Evidence-based cross validation for acoustic power transmission for a novel treatment system

Introduction: The novel Trans-Fusimo Treatment System (TTS) is designed to control Magnetic Resonance guided Focused Ultrasound (MRgFUS) therapy to ablate liver tumours under respiratory motion. It is crucial to deliver the acoustic power within tolerance limits for effective liver tumour treatment via MRgFUS. Before application in a clinical setting, evidence of reproducibility and reliability is a must for safe practice. Materials and methods: The TTS software delivers the acoustic power via ExAblate-2100 Conformal Bone System (CBS) transducer. A built-in quality assurance application was developed to measure the force values, using a novel protocol to measure the efficiency for the electrical power values of 100 and 150W for 6s of sonication. This procedure was repeated 30 times by two independent users against the clinically approved ExAblate-2100 CBS for cross-validation. Results: Both systems proved to deliver the power within the accepted efficiency levels (70–90%). Two sample t-tests were used to assess the differences in force values between the ExAblate-2100 CBS and the TTS (p > 0.05). Bland-Altman plots were used to demonstrate the limits of agreement between the two systems falling within the 10% limits of agreement. Two sample t-tests indicated that TTS does not have user dependency (p > 0.05). Conclusions: The TTS software proved to deliver the acoustic power without exceeding the safety levels. Results provide evidence as a part of ISO13485 regulations for CE marking purposes. The developed methodology could be utilised as a part of quality assurance system in clinical settings; when the TTS is used in clinical practice

Methodology on Quantification of Sonication Duration for Safe Application of MR Guided Focused Ultrasound for Liver Tumour Ablation

Background and objective Magnetic Resonance Guided Focused Ultrasound (MRgFUS) for liver tumour ablation is a challenging task due to motion caused by breathing and occlusion due the ribcage between the transducer and the tumour. To overcome these challenges, a novel system for liver tumour ablation during free breathing has been designed. Methods The novel TRANS-FUSIMO Treatment System (TTS, EUFP7) interacts with a Magnetic Resonance (MR) scanner and a focused ultrasound transducer to sonicate to a moving target in liver. To meet the requirements of ISO 13485; a quality management system for medical device design, the system needs to be tested for certain process parameters. The duration of sonication and, the delay after the sonication button is activated, are among the parameters that need to be quantified for efficient and safe ablation of tumour tissue. A novel methodology is developed to quantify these process parameters. A computerised scope is programmed in LabVIEW to collect data via hydrophone; where the coordinates of fiber-optic sensor assembly was fed into the TRANS-FUSIMO treatment software via Magnetic Resonance Imaging (MRI) to sonicate to the tip of the sensor, which is synchronised with the clock of the scope, embedded in a degassed water tank via sensor assembly holder. The sonications were executed for 50 W, 100 W, 150 W for 10 s to quantify the actual sonication duration and the delay after the emergency stop by two independent operators for thirty times. The deviation of the system from the predefined specs was calculated. Student's-T test was used to investigate the user dependency. Results The duration of sonication and the delay after the sonication were quantified successfully with the developed method. TTS can sonicate with a maximum deviation of 0.16 s (Std 0.32) from the planned duration and with a delay of 14 ms (Std 0.14) for the emergency stop. Student's T tests indicate that the results do not depend on operators (p > .05). Conclusion The evidence obtained via this protocol is crucial for translation- of-research into the clinics for safe application of MRgFUS. The developed protocol could be used for system maintenance in compliance with quality systems in clinics for daily quality assurance routines

Video capsule endoscopy in small-bowel malignancy: A multicenter Belgian study

SCOPUS: ar.jinfo:eu-repo/semantics/publishe

Capsule Endoscopy in paediatrics: Multicentric Belgian study

Bacground and study aims :Capsule Endoscopy (CE) is a non-invasive procedure for evaluating small bowel disease. Data concerning children are scarce. The aim of the present report was to review all paediatric cases investigated by CE in Belgium. Patients and methods :The seven Belgian academic hospitals using the CE device (Given) were asked to collect information on CE performed in patients ≤ 18 years. Main indications for performing VCE, former radiological and endoscopic procedures were collected, as well as final diagnosis and clinical impact of VCE findings. Results :From November 2002 until December 2005, VCE was performed in 17 children (mean age :11.9 years, range :5-18). Indications were occult gastro-intestinal bleeding (OGIB) and/or iron deficiency anaemia (IDA) (10 cases) and chronic and/or recurrent abdominal pain (7 cases). Mean duration of symptoms was 8.6 months. The mean number of endoscopic and radiological procedures before performing CE was 4.2 per patient. Detected lesions were ulcerations (6 cases), jejunal varices (1), ileo-ileal invagination (2), active bleeding (1), and normal findings (7). In the indication of OGIB/IDA, relevant findings having an impact on the diagnosis were found in 60% of the cases. In the group with chronic and recurrent abdominal pain, CE brought relevant findings in 43%. CE findings had an impact on therapy in 44% of the patients. Conclusions :CE could be a useful tool for clinical work-up of difficult paediatric cases, not only in the indication of IDA/OGIB, but also for selected cases of recurrent abdominal pain, but prospective controlled trials including emerging techniques like CT enterography are mandatory.SCOPUS: ar.jinfo:eu-repo/semantics/publishe

BSGIE survey on COVID-19 and gastrointestinal endoscopy in Belgium :results and recommendations

Background and aims: With the first wave of the COVID-19 pandemic declining, activities in the gastrointestinal clinic are being recommenced after a period of stringent measures. Since a second COVID-19 wave is not entirely ruled out health care professionals might remain faced with the need to perform endoscopic procedures in patients with a confirmed positive or unknown COVID-19 status. With this report we aim to provide a practical relevant overview of preparation and protective measures for gastroenterologists based on the currently available guidelines and our local experience and results of a national Belgian survey, to guarantee a fast recall of an adequate infection prevention if COVID-19 reoccurs. Methods: From the 23rd of March 2020 and the 13th of May 2020 we performed a Pubmed, Embase and Medline search, resulting in 37 papers on COVID-19 and endoscopy. Additionally, we combined these data with data acquired from the national BSGIE survey amongst Belgian gastroenterologists. Results: Based on 72 completed surveys in both university and non-university hospitals, the results show (1) a dramatic (<20%) or substantial (<50%) decrease of normal daily endoscopy in 74% and 22% of the units respectively, (2) a difference in screening and protective measures between university and non-university hospitals. These findings were subsequently compared with the current guidelines. Conclusion: Based on new data from the BSGIE survey and current guidelines we tried to realistically represent the current COVID-19 trends in protective measures, screening and indications for endoscopy and to provide a practical overview as preparation for a possible second wave.SCOPUS: re.jinfo:eu-repo/semantics/publishe

Management of COPD according to guidelines. A national survey among Belgian physicians

SCOPUS: ar.jinfo:eu-repo/semantics/publishe