Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry

Sponsors

Lead Sponsor: Weill Medical College of Cornell University

Source Weill Medical College of Cornell University
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 5 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.

Laboratory data, patient characteristics, imaging, histology will be collected. In certain patients - after specific consent extra blood may be collected for research purposes.

Overall Status Recruiting
Start Date April 5, 2016
Completion Date October 31, 2025
Primary Completion Date October 31, 2025
Study Type Observational
Primary Outcome
Measure Time Frame
Change of weight of the various bariatric therapies Baseline, 1 month, 6 months, and 1 year post procedure
Safety of procedure measured by in the number of adverse events of procedure at baseline
Safety of procedure measured by in the number of adverse events that occur within 30 days Within 30 days of the procedure
Secondary Outcome
Measure Time Frame
Technical success of each bariatric therapy. through study completion at one year.
Change and Improvement in comorbidities 6 months, 1 year post procedure
Change and Improvement in comorbidities 6 months, 1 year post procedure
Change and Improvement in comorbidities 6 months, 1 year post procedure
Change in the effect of Endoscopic Bariatric Therapies on reflux Baseline, 6 months,and 1 year post procedure
Change in the effect of Endoscopic Bariatric Therapies on reflux Baseline, 6 months,and 1 year post procedure
Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease Baseline, 6 months,and 1 year post procedure
Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease Baseline, 6 months,and 1 year post procedure
Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease Baseline, 6 months,and 1 year post procedure
Enrollment 9999
Condition
Intervention

Intervention Type: Other

Intervention Name: Endoscopic Bariatric Therapies

Description: 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

Arm Group Label: Endoscopic Bariatric Therapies (EBT).

Eligibility

Sampling Method: Non-Probability Sample

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.

Gender: All

Minimum Age: 18 Years

Maximum Age: 89 Years

Overall Official
Last Name Role Affiliation
Reem Z Sharaiha, MD Principal Investigator Weill Cornell Medicine
Overall Contact

Last Name: Reem Z Sharaiha, MD, MSc.

Phone: 646-962-2382

Email: [email protected]

Location
Facility: Status: Contact: Contact Backup: Investigator: Weill Cornell Medicine Reem Z Sharaiha, MD 646-962-2382 [email protected] Reem Z Sharaiha, MD Principal Investigator
Location Countries

United States

Verification Date

July 2020

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Arm Group

Label: Endoscopic Bariatric Therapies (EBT).

Description: patients undergoing Endoscopic Bariatric Therapies

Acronym EBT
Patient Data No
Study Design Info

Observational Model: Other

Time Perspective: Other

Source: ClinicalTrials.gov