Magnetically Assisted Capsule Endoscopy: A Viable Alternative to Conventional Flexible Endoscopy of the Stomach?

INTRODUCTION: Oesophagogastroduodenoscopy is the investigation of choice to identify mucosal lesions of the upper gastrointestinal tract, but it is poorly tolerated by patients. A simple non-invasive technique to image the upper gastrointestinal tract, which could be made widely available, would be beneficial to patients. Capsule endoscopy is well tolerated by patients but the stomach has proved difficult to visualise accurately with capsule technology due to its’ capacious nature and mucosal folds, which can obscure pathology. MiroCam Navi (Intromedic Ltd, Seoul, Korea) is a capsule endoscope containing a small amount of magnetic material which has been made available with a handheld magnet which might allow a degree of control. This body of work aims to address whether this new technology could be a feasible alternative to conventional flexible endoscopy of the stomach. METHODS: Four studies were conducted to test this research question. The first explores the feasibility of magnetically assisted capsule endoscopy of the stomach and operator learning curve in an ex vivo porcine model. This was followed by a randomised, blinded trial comparing magnetically assisted capsule endoscopy to conventional flexible endoscopy in ex vivo porcine stomach models. Subsequently a prospective, single centre randomised controlled trial in humans examined whether magnetically assisted capsule endoscopy could enhance conventional small bowel capsule endoscopy by reducing gastric transit time. Finally a blinded comparison of diagnostic yield of magnetically assisted capsule endoscopy compared to oesophagogastroduodenoscopy was performed in patients with recurrent or refractory iron deficiency anaemia. RESULTS: In the first study all stomach tags were identified in 87.2% of examinations and a learning curve was demonstrated (mean examination times for the first 23 and second 23 procedures 10.28 and 6.26 minutes respectively (p<0.001). In the second study the difference in sensitivities between oesophagogastroduodenoscopy and conventional flexible endoscopy for detecting beads within an ex vivo porcine stomach model was 1.11 (95% CI 0.06, 28.26) proving magnetically assisted capsule endoscopy to be non-inferior to flexible endoscopy. In the first human study, although there was no significant difference in gastric transit time or capsule endoscopy completion rate between the two groups (p=0.12 and p=0.39 respectively), the time to first pyloric image was significantly shorter in the intervention group (p=0.03) suggesting that magnetic control hastens capsular transit to the gastric antrum but cannot impact upon duodenal passage. In the last study, a total of 38 pathological findings were identified in this comparative study of magnetically assisted capsule endoscopy and conventional endoscopy. Of these, 16 were detected at both procedures, while flexible endoscopy identified 14 additional lesions not seen at magnetically assisted capsule endoscopy and magnetically assisted capsule endoscopy detected 8 abnormalities not seen by oesophagogastroduodenoscopy. No adverse events occurred in either of the human trials. Finally magnetically steerable capsule endoscopy induced less procedural pain, discomfort and distress than oesophagogastroduodenoscopy (p=0.0009, p=0.001 and p=0.006 respectively). CONCLUSION: Magnetically assisted capsule endoscopy is safe, well tolerated and a viable alternative to conventional endoscopy. Further research to develop and improve this new procedure is recommended

Diagnosis of Barrett’s esophagus and Esophageal Varices using a Magnetically Assisted Capsule Endoscopy system

Background and AimsMagnetically assisted capsule endoscopy (MACE) potentially offers a comfortable, patient friendly, and community-based alternative to gastroscopy (EGD). This pilot study aims to explore whether this approach can be used to accurately diagnose Barrett’s esophagus and esophageal varices.MethodsThe MiroCam Navi capsule system was used to examine the upper GI tract in patients due to undergo a clinically indicated EGD. A total of 50 participants were enrolled, of which 34 had known pathology, 17 Barrett’s esophagus (BE), 17 esophageal varices (EV), with 16 controls. Patients underwent the MACE procedure, with the operator blinded to the indication and any previous endoscopic diagnoses. The subsequent EGD was performed by an endoscopist blinded to the MACE findings. Diagnostic yield, comfort and patient preference between the 2 modalities were compared.ResultsParticipants had a mean age of 61 years old, a M:F ratio of 2.1:1, a mean body mass index (BMI) of 29.5, with an average chest measurement of 105.3 cm. Forty-seven patients undertook both procedures; 3 patients were unable to swallow the capsule. With the use of the magnet, it was possible to hold the capsule within the esophagus for a mean duration of 190 seconds and up to a maximum of 634 seconds. A correct real-time MACE diagnosis was made in 11 of 15 patients with EV (sensitivity 73.3% [95% CI, 44.9% - 92.2%] and specificity 100% [95% CI, 89.1% - 100%]) and 15 of 16 patients with BE (sensitivity 93.8% [95% CI, 69.8% - 99.8%] and a specificity of 100% [95% CI, 88.8% - 100%]). MACE was considered more comfortable than conventional endoscopy (p [less than] 0.0001) with a mean score of 9.2 with MACE compared with 6.7 with EGD, when assessed on a 10-point scale. No MACE or EGD -elated adverse events occurred.ConclusionThis pilot study demonstrates that MACE is both safe and well tolerated by patients. Accuracy for the diagnosis of BE was high and may therefore have a role in screening for this condition

Low-Cost Technologies for Flexible Endoscopy: Design, Control and Autonomy for a Water-Jet Actuated Soft Continuum Endoscope

Despite the outstanding diagnostic performance brought by new technologies in medicine, cancer remains a significant burden worldwide. In addition to prevention strategies, the ability to detect malignancy early is crucial in enabling effective treatment and dramatically increasing the survival rate of patients. In the case of gastric cancer, diagnosis is generally performed using Flexible Endoscopy (or Endoscope) (FE). The FE has been proven to be a powerful, reliable and cost-effective tool in the fight against gastric cancer. However, its effectiveness strongly depends on the skills of trained Gastro Enterologists (GE) who perform the procedures. Moreover, accessibility and availability of such tools are often limited to people residing in major cities, while remote and rural areas remain poorly served by their health systems. The advent of robotics in medicine offers a new solution to these problems. When possible, automating diagnostic procedures or surgical tasks has the potential to deliver reliable, repeatable and cost-effective alternatives to standard human-in-the-loop procedures. Embedding autonomous capabilities into a machine, optimally designed to execute a specific task, could enable the device to automatically adapt to different conditions and non-skilled personnel to perform the procedure by supervising the actions of the robotic platform. In these scenarios, safety represents a major concern and in the majority of the cases, a safe interaction between the robot and the tissues can be guaranteed by building compliant robots made of soft materials. However, if the possibility of using compliant devices offers a number of advantages to the final user or patient, it defines a series of technical challenges that have to be addressed to deliver a stable and reliable control of the platform. Finally, by adopting low-cost designs, single-use solutions can be realised to address the issue and complication of sterilisation. This dissertation discusses the research effort targeted at the development of a water-jet actuated low-cost, disposable gastroscopy platform to offer a safe, cost-effective, fault-free alternative to standard FE

Design, analysis and trajectory tracking control of underactuated mobile capsule robots.

The research on capsule robots (capsubots) has received attraction in recent years because of their compactness, simple structure and their potential use in medical diagnosis (e.g. capsule endoscopy), treatment and surgical assistance. The medical diagnostic capability of a capsule endoscope - which moves with the aid of visceral peristalsis - in the GI (gastro-intestinal) tract can be improved by adding propulsion to it e.g. legged, magnetic or capsubot-type propulsion. Driven by the above needs this thesis presents the design, analysis, trajectory tracking control and implementation of underactuated mobile capsule robots. These capsule robots can be modified and used in in-vivo medical applications. Researches on the capsubottype underactuated system focus on the stabilization of the robot and tracking the actuated configuration. However trajectory tracking control of an unactuated configuration (i.e. the robotmotion)was not considered in the literature though it is the primary requirement of any mobile robot and also crucial for many applications such as in-vivo inspection. Trajectory tracking control for this class of underactuated mechanical systems is still an open issue. This thesis presents a strategy to solve this issue. This thesis presents three robots namely a one-dimensional (1D) capsule robot, a 2D capsule robot and a 2D hybrid capsule robot with incremental capability. Two new acceleration profiles (utroque and contrarium) for the inner mass (IM) - internal moving part of the capsule robot - are proposed, analysed and implemented for the motion generation of the capsule robots. This thesis proposes a two-stage control strategy for the motion control of an underactuated capsule robot. A segment-wise trajectory tracking algorithm is developed for the 1D capsule robot. Theoretical analysis of the algorithm is presented and simulation is performed in the Matlab/Simulink environment based on the theoretical analysis. The algorithm is implemented in the developed capsule robot, the experimentation is performed and the results are critically analyzed. A trajectory tracking control algorithm combining segment-wise and behaviour-based control is proposed for the 2D capsule robot. Detailed theoretical analysis is presented and the simulation is performed to investigate the robustness of the trajectory tracking algorithm to friction uncertainties. A 2D capsule robot prototype is developed and the experimentation is performed. A novel 2D hybrid robot with four modes of operation - legless motion mode, legged motion mode, hybrid motion mode and anchoring mode - is also designed which uses one set of actuators in all operating modes. The theoretical analysis, modelling and simulation is performed. This thesis demonstrates effective ways of propulsion for in-vivo applications. The outer-shape of the 1D and 2D capsule robots can be customized according to the requirement of the applications, as the propulsion mechanisms are completely internal. These robots are also hermetically sealable (enclosed) which is a safety feature for the in-vivo robots. This thesis addresses the trajectory tracking control of the capsubot-type robot for the first time. During the experimentation the 1D robot prototype tracks the desired position trajectory with some error (relative mean absolute error: 16%). The trajectory tracking performance for the 2D capsubot improves as the segment time decreases whereas tracking performance declines as the friction uncertainty increases. The theoretical analysis, simulation and experimental results validate the proposed acceleration profiles and trajectory tracking control algorithms. The designed hybrid robot combines the best aspects of the legless and legged motions. The hybrid robot is capable of stopping in a suspected region and remain stationary for a prolonged observation for the in-vivo applications while withstanding the visceral peristalsis

European position paper on rhinosinusitis and nasal polyps 2020

The European Position Paper on Rhinosinusitis and Nasal Polyps 2020 is the update of similar evidence based position papers published in 2005 and 2007 and 2012. The core objective of the EPOS2020 guideline is to provide revised, up-to-date and clear evidence-based recommendations and integrated care pathways in ARS and CRS. EPOS2020 provides an update on the literature published and studies undertaken in the eight years since the EPOS2012 position paper was published and addresses areas not extensively covered in EPOS2012 such as paediatric CRS and sinus surgery. EPOS2020 also involves new stakeholders, including pharmacists and patients, and addresses new target users who have become more involved in the management and treatment of rhinosinusitis since the publication of the last EPOS document, including pharmacists, nurses, specialised care givers and indeed patients themselves, who employ increasing self-management of their condition using over the counter treatments. The document provides suggestions for future research in this area and offers updated guidance for definitions and outcome measurements in research in different settings. EPOS2020 contains chapters on definitions and classification where we have defined a large number of terms and indicated preferred terms. A new classification of CRS into primary and secondary CRS and further division into localized and diffuse disease, based on anatomic distribution is proposed. There are extensive chapters on epidemiology and predisposing factors, inflammatory mechanisms, (differential) diagnosis of facial pain, allergic rhinitis, genetics, cystic fibrosis, aspirin exacerbated respiratory disease, immunodeficiencies, allergic fungal rhinosinusitis and the relationship between upper and lower airways. The chapters on paediatric acute and chronic rhinosinusitis are totally rewritten. All available evidence for the management of acute rhinosinusitis and chronic rhinosinusitis with or without nasal polyps in adults and children is systematically reviewed and integrated care pathways based on the evidence are proposed. Despite considerable increases in the amount of quality publications in recent years, a large number of practical clinical questions remain. It was agreed that the best way to address these was to conduct a Delphi exercise . The results have been integrated into the respective sections. Last but not least, advice for patients and pharmacists and a new list of research needs are included

European Position Paper on Rhinosinusitis and Nasal Polyps 2020

The European Position Paper on Rhinosinusitis and Nasal Polyps 2020 is the update of similar evidence based position papers published in 2005 and 2007 and 2012. The core objective of the EPOS2020 guideline is to provide revised, up-to-date and clear evidence-based recommendations and integrated care pathways in ARS and CRS. EPOS2020 provides an update on the literature published and studies undertaken in the eight years since the EPOS2012 position paper was published and addresses areas not extensively covered in EPOS2012 such as paediatric CRS and sinus surgery. EPOS2020 also involves new stakeholders, including pharmacists and patients, and addresses new target users who have become more involved in the management and treatment of rhinosinusitis since the publication of the last EPOS document, including pharmacists, nurses, specialised care givers and indeed patients themselves, who employ increasing self-management of their condition using over the counter treatments. The document provides suggestions for future research in this area and offers updated guidance for definitions and outcome measurements in research in different settings. EPOS2020 contains chapters on definitions and classification where we have defined a large number of terms and indicated preferred terms. A new classification of CRS into primary and secondary CRS and further division into localized and diffuse disease, based on anatomic distribution is proposed. There are extensive chapters on epidemiology and predisposing factors, inflammatory mechanisms, (differential) diagnosis of facial pain, allergic rhinitis, genetics, cystic fibrosis, aspirin exacerbated respiratory disease, immunodeficiencies, allergic fungal rhinosinusitis and the relationship between upper and lower airways. The chapters on paediatric acute and chronic rhinosinusitis are totally rewritten. All available evidence for the management of acute rhinosinusitis and chronic rhinosinusitis with or without nasal polyps in adults and children is systematically reviewed and integrated care pathways based on the evidence are proposed. Despite considerable increases in the amount of quality publications in recent years, a large number of practical clinical questions remain. It was agreed that the best way to address these was to conduct a Delphi exercise. The results have been integrated into the respective sections. Last but not least, advice for patients and pharmacists and a new list of research needs are included.Peer reviewe

European Position Paper on Rhinosinusitis and Nasal Polyps 2020

The European Position Paper on Rhinosinusitis and Nasal Polyps 2020 is the update of similar evidence based position papers published in 2005 and 2007 and 2012. The core objective of the EPOS2020 guideline is to provide revised, up-to-date and clear evidence-based recommendations and integrated care pathways in ARS and CRS. EPOS2020 provides an update on the literature published and studies undertaken in the eight years since the EPOS2012 position paper was published and addresses areas not extensively covered in EPOS2012 such as paediatric CRS and sinus surgery. EPOS2020 also involves new stakeholders, including pharmacists and patients, and addresses new target users who have become more involved in the management and treatment of rhinosinusitis since the publication of the last EPOS document, including pharmacists, nurses, specialised care givers and indeed patients themselves, who employ increasing self-management of their condition using over the counter treatments. The document provides suggestions for future research in this area and offers updated guidance for definitions and outcome measurements in research in different settings. EPOS2020 contains chapters on definitions and classification where we have defined a large number of terms and indicated preferred terms. A new classification of CRS into primary and secondary CRS and further division into localized and diffuse disease, based on anatomic distribution is proposed. There are extensive chapters on epidemiology and predisposing factors, inflammatory mechanisms, (differential) diagnosis of facial pain, allergic rhinitis, genetics, cystic fibrosis, aspirin exacerbated respiratory disease, immunodeficiencies, allergic fungal rhinosinusitis and the relationship between upper and lower airways. The chapters on paediatric acute and chronic rhinosinusitis are totally rewritten. All available evidence for the management of acute rhinosinusitis and chronic rhinosinusitis with or without nasal polyps in adults and children is systematically reviewed and integrated care pathways based on the evidence are proposed. Despite considerable increases in the amount of quality publications in recent years, a large number of practical clinical questions remain. It was agreed that the best way to address these was to conduct a Delphi exercise . The results have been integrated into the respective sections. Last but not least, advice for patients and pharmacists and a new list of research needs are included. The full document can be downloaded for free on the website of this journal: http://www.rhinologyjournal.com