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

Obesity Clinical Trial

— EBT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04494048
• Other study ID #: 1510016654
• Status: Recruiting
• Start date: April 5, 2016
• Est. completion date: October 31, 2025

Study information

• Verified date: July 2023
• Source: Weill Medical College of Cornell University
• Contact: Reem Z Sharaiha, MD, MSc.
• Phone: 646-962-2382
• Email: rzs9001[@]med.cornell.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 9999
• Est. completion date: October 31, 2025
• Est. primary completion date: October 31, 2025
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Bariatric Surgery Candidate
• Gastro Esophageal Reflux
• Gastroesophageal Reflux
• Obesity
• Weight Loss

Intervention

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

Locations

Country	Name	City	State
United States	Weill Cornell Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Weill Medical College of Cornell University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	Technical success of each bariatric therapy.	Technical success is the technical success of the procedure.	through study completion at one year.
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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