Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: Endoscopic Bariatric Therapies.
- Кому может быть актуально
- Состояния в реестре: Obesity, Weight Loss, Gastro Esophageal Reflux, Bariatric Surgery Candidate. Базовые параметры: 18 лет — 89 лет · Все.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- США
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The purpose of this registry study is to collect data through medical chart review and in patient visits on the efficacy and safety of various Endoscopic Bariatric therapies (EBTs). This is a retrospective and prospective, observational, medical chart review study for at least 6 standard of care visits up to 1 years after a subject consents for study participation.
Подробное описание
Endoscopic bariatric therapies such as intragastric balloons, space occupying EBTs, endoscopic sleeve gastroplasty (ESG), primary obesity surgery endolumenal (POSE), and small bowel interventions including gastrointestinal bypass sleeves, etc. are recommended alone or in conjunction with other weight loss treatment modules for patients who cannot or do not want to undergo conventional bariatric surgery or other therapies for obesity (with BMI ≥30 kg/m2) or BMI \>27 with comorbidities.
This research is being done in order to find out if endoscopic bariatric therapies work as well as, or better or worse than, other currently available treatment modules to achieve weight loss.
The study is to create a registry to analyze a longitudinal observational cohort of patients who have undergone endobariatric procedures. We will collect information through standard of practice visits and through chart review.
Laboratory data, patient characteristics, imaging, histology will be collected. In certain patients - after specific consent extra blood may be collected for research purposes.
Вмешательства
- Другое Endoscopic Bariatric Therapies
Participation in this study will allow for data collection through medical chart review for at least 6 standard of care visits up to 1 year after consenting to participate in this registry study. The exposure of interest is total body weight loss, safety and efficacy
Первичные конечные точки
- Change of weight of the various bariatric therapies [Срок оценки: Baseline, 1 month, 6 months, and 1 year post procedure]
- Safety of procedure measured by in the number of adverse events of procedure [Срок оценки: at baseline]
- Safety of procedure measured by in the number of adverse events that occur within 30 days [Срок оценки: Within 30 days of the procedure]
Вторичные конечные точки (9)
- Technical success of each bariatric therapy. [Срок оценки: through study completion at one year.]
- Change and Improvement in comorbidities [Срок оценки: 6 months, 1 year post procedure]
- Change and Improvement in comorbidities [Срок оценки: 6 months, 1 year post procedure]
- Change and Improvement in comorbidities [Срок оценки: 6 months, 1 year post procedure]
- Change in the effect of Endoscopic Bariatric Therapies on reflux [Срок оценки: Baseline, 6 months,and 1 year post procedure]
- Change in the effect of Endoscopic Bariatric Therapies on reflux [Срок оценки: Baseline, 6 months,and 1 year post procedure]
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Срок оценки: Baseline, 6 months,and 1 year post procedure]
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Срок оценки: Baseline, 6 months,and 1 year post procedure]
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Срок оценки: Baseline, 6 months,and 1 year post procedure]
Критерии участия
Критерии включения
- Any patient who is considering undergoing EBT for weight loss within 6 months, or has undergone clinically indicated EBT for weight loss within the past 6 months
- Above or equal to 18 years of age.
Критерии исключения
- Any patient who has not undergone or will undergo EBT for weight loss
- Below 18 years of age.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Дизайн исследования
- Модель наблюдения
- Другое
Центры проведения
США · 1 центр
- Weill Cornell Medicine — New York
Публикации
- Lahooti A, Westerveld D, Johnson K, Aneke-Nash C, Baig MU, Akagbosu C, Hanscom M, Buckholz A, Newberry C, Herr A, Schwartz R, Yeung M, Sampath K, Mahadev S, Kumar S, Carr-Locke D, Aronne L, Shukla A, Sharaiha RZ. Improvement in obesity-related comorbidities 5 years after endoscopic sleeve gastroplasty: a prospective cohort study. Gastrointest Endosc. 2025 Jul;102(1):26-36. doi: 10.1016/j.gie.2024. PMID 39694295
Идентификаторы
NCT: NCT04494048 · 1510016654