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

Study Overview
=================
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.

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

Conditions
-----------------
Obesity, Weight Loss, Gastro Esophageal Reflux, Bariatric Surgery Candidate

Intervention / Treatment
-----------------
* Other: Endoscopic Bariatric Therapies


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Endoscopic Bariatric Therapies (EBT).<br>patients undergoing Endoscopic Bariatric Therapies | Other: Endoscopic Bariatric Therapies<br>* 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<br>|

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 |