2,774 research outputs found

    Post-Ablation Cavity Evaluation: A Prospective Multicenter Observational Clinical Study to Evaluate Hysteroscopic Access to the Uterine Cavity 4 Years after Water Vapor Endometrial Ablation for the Treatment of Heavy Menstrual Bleeding

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    Study Objective: Patients who have undergone endometrial ablation may present a diagnostic challenge when they subsequently develop vaginal bleeding, pelvic pain, or postmenopausal bleeding. Extensive scarring of the uterine cavity often precludes evaluation and/or conservative treatment. For further research on this topic, we performed hysteroscopic examination in study subjects a mean duration of 4 years after they had undergone water vapor endometrial ablation. Design: Prospective, multicenter, observational clinical study. Setting: Eight private practice or outpatient sites in the United States and Mexico. Patients: Seventy subjects who had completed their 36-month follow-up in the AEGEA Pivotal Trial. Interventions: Diagnostic hysteroscopy. Measurements and Main Results: The subjects were screened for general health and infection and underwent diagnostic hysteroscopy. Menstrual bleeding status was recorded. The video of the hysteroscopic examination was analyzed by an independent reviewer, who assessed uterine cavity access and visualization of the cornua and tubal ostia as well as characterized adhesions on the basis of the criteria by March et al. An independent reviewer also subjectively assessed whether Pipelle endometrial biopsy or intrauterine device placement would be feasible. Uterine cavity access was achieved in 90% (63/70) of subjects. Among subjects with cavity access, the cornua and ostia were visualized in 79% (50/63) and adhesions were absent in 75% (47/63), with only 2 women having severe adhesions (3%, 2/63). Biopsy was projected to be feasible in 86% (62/70) and intrauterine device placement in 60% (42/70) of all subjects. The subjects’ bleeding statuses were not correlated with uterine cavity access. The results were consistent for subjects with large uterine cavities and International Federation of Gynecologic and Obstetrics type II to VI myomas ≤4 cm. Conclusion: Water vapor endometrial ablation preserved an accessible uterine cavity and visualization of the ostia in most subjects, with minimal incidence of severe adhesions, a mean of 4 years after the ablation procedure

    JWST Ground Segment and Operations Integration and Testing

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    This viewgraph presentation reviews the operations integration and testing associated with the JWST ground network

    James Webb Space Telescope - Applying Lessons Learned to I&T

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    The James Webb Space Telescope (JWST) is part of a new generation of spacecraft acquiring large data volumes from remote regions in space. To support a mission such as the JWST, it is imperative that lessons learned from the development of previous missions such as the Hubble Space Telescope and the Earth Observing System mission set be applied throughout the development and operational lifecycles. One example of a key lesson that should be applied is that core components, such as the command and telemetry system and the project database, should be developed early, used throughout development and testing, and evolved into the operational system. The purpose of applying lessons learned is to reap benefits in programmatic or technical parameters such as risk reduction, end product quality, cost efficiency, and schedule optimization. In the cited example, the early development and use of the operational command and telemetry system as well as the establishment of the intended operational database will allow these components to be used by the developers of various spacecraft components such that development, testing, and operations will all use the same core components. This will reduce risk through the elimination of transitions between development and operational components and improve end product quality by extending the verification of those components through continual use. This paper will discuss key lessons learned that have been or are being applied to the JWST Ground Segment integration and test program

    James Webb Space Telescope - L2 Communications for Science Data Processing

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    JWST is the first NASA mission at the second Lagrange point (L2) to identify the need for data rates higher than 10 megabits per second (Mbps). JWST will produce approximately 235 Gigabits of science data every day that will be downlinked to the Deep Space Network (DSN). To get the data rates desired required moving away from X-band frequencies to Ka-band frequencies. To accomplish this transition, the DSN is upgrading its infrastructure. This new range of frequencies are becoming the new standard for high data rate science missions at L2. With the new frequency range, the issues of alternatives antenna deployment, off nominal scenarios, NASA implementation of the Ka-band 26 GHz, and navigation requirements will be discussed in this paper. JWST is also using Consultative Committee for Space Data Systems (CCSDS) standard process for reliable file transfer using CCSDS File Delivery Protocol (CFDP). For JWST the use of the CFDP protocol provides level zero processing at the DSN site. This paper will address NASA implementations of Ground Stations in support of Ka-band 26 GHz and lesson learned from implementing a file base (CFDP) protocol operational system

    12-Month Outcomes of the US Patient Cohort in the SONATA Pivotal IDE Trial of Transcervical Ablation of Uterine Fibroids.

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    Objective: The prospective SONATA pivotal Investigational Device Exemption (IDE) trial was performed in the United States (US) and Mexico to examine the safety and effectiveness of transcervical fibroid ablation (TFA) in the treatment of symptomatic uterine fibroids. This is an analysis of 12-month clinical outcomes in the US cohort. Methods: TFA with the Sonata System was performed on women with symptomatic uterine fibroids. The 12-month co-primary endpoints were reduction in menstrual blood loss and freedom from surgical reintervention. Symptom severity, quality of life, patient satisfaction, safety, and reductions in uterine and fibroid volumes were also evaluated. Results: One hundred twenty-five patients were enrolled and treated in the US. Both co-primary endpoints were achieved in this US-based cohort, as 65.3% of patients reported ≥50% reduction in menstrual bleeding and 99.2% of patients were free from surgical reintervention. Symptom improvement was noted by 97.4% of patients and 98.3% were satisfied. Ninety-five percent of patients reported reduced menstrual bleeding at 12 months, and 86.8% noted \u3e20% reduction. Significant mean improvements at 12 months were realized in both symptom severity and health-related quality of life (33.8 points and 45.8 points, respectively; all P\u3c0.0001). Mean maximal fibroid volume reduction per patient was 63.8%. There was a 0% incidence of device related adverse events. Mean length of stay was 2.5 hrs and 50% of patients returned to normal activity within 1 day. Conclusion: This analysis of US patients in the SONATA pivotal IDE trial demonstrates results consistent with those in the full cohort. TFA with Sonata significantly reduced fibroid symptoms with a low surgical reintervention rate through 12 months. These results support the efficacy and safety of the Sonata system as a first-line treatment for women affected by symptomatic uterine fibroids

    The Building Blocks for JWST I and T (Integrations and Test) to Operations - From Simulator to Flight Units

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    The James Webb Space Telescope (JWST) Project has an extended integration and test (I&T) phase due to long procurement and development times of various components as well as recent launch delays. The JWST Ground Segment and Operations group has developed a roadmap of the various ground and flight elements and their use in the various JWST I&T test programs. The JWST Project s building block approach to the eventual operational systems, while not new, is complex and challenging; a large-scale mission like JWST involves international partners, many vendors across the United States, and competing needs for the same systems. One of the challenges is resource balancing so simulators and flight products for various elements congeal into integrated systems used for I&T and flight operations activities. This building block approach to an incremental buildup provides for early problem identification with simulators and exercises the flight operations systems, products, and interfaces during the JWST I&T test programs. The JWST Project has completed some early I&T with the simulators, engineering models and some components of the operational ground system. The JWST Project is testing the various flight units as they are delivered and will continue to do so for the entire flight and operational system. The JWST Project has already and will continue to reap the value of the building block approach on the road to launch and flight operations

    A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results

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    AbstractStudy ObjectiveTo assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women.DesignMulticenter, randomized, controlled, international study (Canadian Task Force classification I).SettingThirteen academic and private medical centers.PatientsPremenopausal women (n = 153) suffering from heavy menstrual bleeding (PALM-COEIN: E, O).InterventionPatients were treated using the Minerva Endometrial Ablation System or rollerball ablation.Measurements and Main ResultsAt 1-year post-treatment, study success (alkaline hematin ≤80 mL) was observed in 93.1% of Minerva subjects and 80.4% of rollerball subjects with amenorrhea reported by 71.6% and 49% of subjects, respectively. The mean procedure times were 3.1 minutes for Minerva and 17.2 minutes for rollerball. There were no intraoperative adverse events and/or complications reported.ConclusionThe results of this multicenter randomized controlled trial demonstrate that at the 12-month follow-up, the Minerva procedure produces statistically significantly higher rates of success, amenorrhea, and patient satisfaction as well as a shorter procedure time when compared with the historic criterion standard of rollerball ablation. Safety results were excellent and similar for both procedures

    The inpatient burden of abdominal and gynecological adhesiolysis in the US

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    <p>Abstract</p> <p>Background</p> <p>Adhesions are fibrous bands of scar tissue, often a result of surgery, that form between internal organs and tissues, joining them together abnormally. Postoperative adhesions frequently occur following abdominal surgery, and are associated with a large economic burden. This study examines the inpatient burden of adhesiolysis in the United States (i.e., number and rate of events, cost, length of stay [LOS]).</p> <p>Methods</p> <p>Hospital discharge data for patients with primary and secondary adhesiolysis were analyzed using the 2005 Healthcare Cost and Utilization Project's Nationwide Inpatient Sample. Procedures were aggregated by body system.</p> <p>Results</p> <p>We identified 351,777 adhesiolysis-related hospitalizations: 23.2% for primary and 76.8% for secondary adhesiolysis. The average LOS was 7.8 days for primary adhesiolysis. We found that 967,332 days of care were attributed to adhesiolysis-related procedures, with inpatient expenditures totaling 2.3billion(2.3 billion (1.4 billion for primary adhesiolysis; 926millionforsecondaryadhesiolysis).Hospitalizationsforadhesiolysisincreasedsteadilybyageandwerehigherforwomen.Ofsecondaryadhesiolysisprocedures,46.3926 million for secondary adhesiolysis). Hospitalizations for adhesiolysis increased steadily by age and were higher for women. Of secondary adhesiolysis procedures, 46.3% involved the female reproductive tract, resulting in 57,005 additional days of care and 220 million in attributable costs.</p> <p>Conclusions</p> <p>Adhesiolysis remain an important surgical problem in the United States. Hospitalization for this condition leads to high direct surgical costs, which should be of interest to providers and payers.</p
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