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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 1 years after a subject consents for study participation.
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.
The study is to create a registry to analyze a longitudinal observational cohort of patients who have undergone endobariatric procedures. We will collect information through standard of practice visits and through chart review.
Laboratory data, patient characteristics, imaging, histology will be collected. In certain patients - after specific consent extra blood may be collected for research purposes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Endoscopic Bariatric Therapies (EBT). | patients undergoing Endoscopic Bariatric Therapies |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Endoscopic Bariatric Therapies | Other | 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 |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Individuals who will undergo Endoscopic bariatric therapies.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Reem Z Sharaiha, MD, MSc. | Contact | 646-962-2382 | rzs9001@med.cornell.edu | |
| Andrea M Herr, NP | Contact | 646-962-2382 | anb9057@med.cornell.edu |
| Name | Affiliation | Role |
|---|---|---|
| Reem Z Sharaiha, MD | Weill Medical College of Cornell University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Weill Cornell Medicine | Recruiting | New York | New York | 10021 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39694295 | Derived | Lahooti A, Westerveld D, Johnson K, Aneke-Nash C, Baig MU, Akagbosu C, Hanscom M, Buckholz A, Newberry C, Herr A, Schwartz R, Yeung M, Sampath K, Mahadev S, Kumar S, Carr-Locke D, Aronne L, Shukla A, Sharaiha RZ. Improvement in obesity-related comorbidities 5 years after endoscopic sleeve gastroplasty: a prospective cohort study. Gastrointest Endosc. 2025 Jul;102(1):26-36. doi: 10.1016/j.gie.2024.12.017. Epub 2024 Dec 16. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D015431 | Weight Loss |
| D005764 | Gastroesophageal Reflux |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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|
| 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 |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |