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

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.

Study Overview

• Status: Recruiting
• Conditions: Obesity; Weight Loss; Gastro Esophageal Reflux; Bariatric Surgery Candidate
• Intervention / Treatment: Other: Endoscopic Bariatric Therapies

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.

• Study Type: Observational
• Enrollment (Estimated): 9999

Contacts and Locations

• Study Contact: Name: Reem Z Sharaiha, MD, MSc.; Phone Number: 646-962-2382; Email: rzs9001@med.cornell.edu
• Study Contact Backup: Name: Andrea M Herr, NP; Phone Number: 646-962-2382; Email: anb9057@med.cornell.edu

Study Locations

• United States
  • New York
    • New York, New York, United States, 10021
      • Recruiting
      • Weill Cornell Medicine
      • Contact: Reem Z Sharaiha, MD; Phone Number: 646-962-2382; Email: rzs9001@med.cornell.edu
      • Contact: Andrea M Herr, NP; Phone Number: 6469622382; Email: anb9057@med.cornell.edu
      • Principal Investigator: Reem Z Sharaiha, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 89 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

Individuals who will undergo Endoscopic bariatric therapies.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Other

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endoscopic Bariatric Therapies (EBT).; patients undergoing Endoscopic Bariatric Therapies	Other: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change of weight of the various bariatric therapies	Compare mean percentage total body weight loss achieved via various Endoscopic Bariatric Therapies compared to baseline, 1 month, 6 months and 1 . year post procedure. This will be calculated by measuring the patients weight on a scale and comparing it to their baseline weight pre procedure.	Baseline, 1 month, 6 months, and 1 year post procedure
Safety of procedure measured by in the number of adverse events of procedure	Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline	at baseline
Safety of procedure measured by in the number of adverse events that occur within 30 days	Number of adverse events; Type (unexpected, expected, related, possibly related)	Within 30 days of the procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Technical success of each bariatric therapy.	Technical success is the technical success of the procedure.	through study completion at one year.
Change and Improvement in comorbidities	measuring certain anthropometric measurements at baseline and at 6 months and one year. Waist Circumference in cm	6 months, 1 year post procedure
Change and Improvement in comorbidities	measuring certain anthropometric measurements at baseline and at 6 months and one year. Blood pressure mmHg	6 months, 1 year post procedure
Change and Improvement in comorbidities	measuring certain anthropometric measurements at baseline and at 6 months and one year. These include laboratory measurements (tryglicerides, LDL, A1C, Insulin)	6 months, 1 year post procedure
Change in the effect of Endoscopic Bariatric Therapies on reflux	measuring change in gastrointestinal reflux disease (GERD) questionnaire answers	Baseline, 6 months,and 1 year post procedure
Change in the effect of Endoscopic Bariatric Therapies on reflux	measuring change in ph measurement on ph manometry	Baseline, 6 months,and 1 year post procedure
Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease	Measuring change in fibroscan score	Baseline, 6 months,and 1 year post procedure
Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease	Measuring change in liver biopsy results	Baseline, 6 months,and 1 year post procedure
Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease	Measuring change in liver functions tests (on blood draw alanine alanine aminotransferase (ALT), AST (aspartate aminotransferase) )	Baseline, 6 months,and 1 year post procedure

Collaborators and Investigators

• Sponsor: Weill Medical College of Cornell University
• Investigators: Principal Investigator: Reem Z Sharaiha, MD, Weill Medical College of Cornell University

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2016
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: May 13, 2020
• First Submitted That Met QC Criteria: July 27, 2020
• First Posted (Actual): July 31, 2020

Study Record Updates

• Last Update Posted (Actual): July 27, 2023
• Last Update Submitted That Met QC Criteria: July 25, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Body Weight; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Body Weight Changes; Gastroesophageal Reflux; Weight Loss
• Other Study ID Numbers: 1510016654

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No