Clinical trial NCT04494048: Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry
Official title: Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Obesity
Weight Loss
Gastro Esophageal Reflux
Bariatric Surgery Candidate
Lead sponsor: Weill Medical College of Cornell University
Sponsor class: OTHER
First posted: 2020-07-31
Enrollment: 9999
Sex: ALL
Minimum age (years): 18
Maximum age (years): 89
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals who will undergo Endoscopic bariatric therapies.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* Any patient who has not undergone or will undergo EBT for weight loss
* Below 18 years of age.

Primary outcomes:
measure: Change of weight of the various bariatric therapies
timeFrame: Baseline, 1 month, 6 months, and 1 year post procedure
measure: Safety of procedure measured by in the number of adverse events of procedure
timeFrame: at baseline
measure: Safety of procedure measured by in the number of adverse events that occur within 30 days
timeFrame: Within 30 days of the procedure
Secondary outcomes:
measure: Technical success of each bariatric therapy.
timeFrame: through study completion at one year.
measure: Change and Improvement in comorbidities
timeFrame: 6 months, 1 year post procedure
measure: Change and Improvement in comorbidities
timeFrame: 6 months, 1 year post procedure
measure: Change and Improvement in comorbidities
timeFrame: 6 months, 1 year post procedure
measure: Change in the effect of Endoscopic Bariatric Therapies on reflux
timeFrame: Baseline, 6 months,and 1 year post procedure
measure: Change in the effect of Endoscopic Bariatric Therapies on reflux
timeFrame: Baseline, 6 months,and 1 year post procedure
measure: Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease
timeFrame: Baseline, 6 months,and 1 year post procedure
measure: Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease
timeFrame: Baseline, 6 months,and 1 year post procedure
measure: Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease
timeFrame: Baseline, 6 months,and 1 year post procedure
Other outcomes:
Locations:
city: New York
country: United States
facility: Weill Cornell Medicine
state: New York
Study officials:
affiliation: Weill Medical College of Cornell University
name: Reem Z Sharaiha, MD
role: PRINCIPAL_INVESTIGATOR
References: