Endoscopic Bariatric Therapies (EBTs): A Retrospective and Prospective Multicenter Registry
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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 Design
Arms and Interventions
| Arm | 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
|
Outcome Measures
Primary Outcome Measures
- Change of weight of the various bariatric therapies [Baseline, 1 month, 6 months, and 1 year post procedure]
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.
- Safety of procedure measured by in the number of adverse events of procedure [at baseline]
Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline
- Safety of procedure measured by in the number of adverse events that occur within 30 days [Within 30 days of the procedure]
Number of adverse events; Type (unexpected, expected, related, possibly related)
Secondary Outcome Measures
- Technical success of each bariatric therapy. [through study completion at one year.]
Technical success is the technical success of the procedure.
- Change and Improvement in comorbidities [6 months, 1 year post procedure]
measuring certain anthropometric measurements at baseline and at 6 months and one year. Waist Circumference in cm
- Change and Improvement in comorbidities [6 months, 1 year post procedure]
measuring certain anthropometric measurements at baseline and at 6 months and one year. Blood pressure mmHg
- Change and Improvement in comorbidities [6 months, 1 year post procedure]
measuring certain anthropometric measurements at baseline and at 6 months and one year. These include laboratory measurements (tryglicerides, LDL, A1C, Insulin)
- Change in the effect of Endoscopic Bariatric Therapies on reflux [Baseline, 6 months,and 1 year post procedure]
measuring change in gastrointestinal reflux disease (GERD) questionnaire answers
- Change in the effect of Endoscopic Bariatric Therapies on reflux [Baseline, 6 months,and 1 year post procedure]
measuring change in ph measurement on ph manometry
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Baseline, 6 months,and 1 year post procedure]
Measuring change in fibroscan score
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Baseline, 6 months,and 1 year post procedure]
Measuring change in liver biopsy results
- Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease [Baseline, 6 months,and 1 year post procedure]
Measuring change in liver functions tests (on blood draw alanine alanine aminotransferase (ALT), AST (aspartate aminotransferase) )
Eligibility Criteria
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Weill Cornell Medicine | New York | New York | United States | 10021 |
Sponsors and Collaborators
- Weill Medical College of Cornell University
Investigators
- Principal Investigator: Reem Z Sharaiha, MD, Weill Medical College of Cornell University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 1510016654