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NCT Number: NCT04494048

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

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.

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Key information

Conditions

Obesity Bariatric Surgery Candidate Body Weight Body Weight Changes Deglutition Disorders Digestive System Diseases Esophageal Diseases Esophageal Motility Disorders Gastro Esophageal Reflux Gastroesophageal Reflux Gastrointestinal Diseases Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms Weight Loss

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Change of weight of the various bariatric therapies

    Time frame: 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.

  2. Safety of procedure measured by in the number of adverse events of procedure

    Time frame: at baseline

    Number of adverse events; Type (unexpected, expected, related, possibly related), frequency and intensity of adverse events at baseline

  3. Safety of procedure measured by in the number of adverse events that occur within 30 days

    Time frame: Within 30 days of the procedure

    Number of adverse events; Type (unexpected, expected, related, possibly related)

Secondary outcomes

  1. Technical success of each bariatric therapy.

    Time frame: through study completion at one year.

    Technical success is the technical success of the procedure.

  2. Change and Improvement in comorbidities

    Time frame: 6 months, 1 year post procedure

    measuring certain anthropometric measurements at baseline and at 6 months and one year. Waist Circumference in cm

  3. Change and Improvement in comorbidities

    Time frame: 6 months, 1 year post procedure

    measuring certain anthropometric measurements at baseline and at 6 months and one year. Blood pressure mmHg

  4. Change and Improvement in comorbidities

    Time frame: 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)

  5. Change in the effect of Endoscopic Bariatric Therapies on reflux

    Time frame: Baseline, 6 months,and 1 year post procedure

    measuring change in gastrointestinal reflux disease (GERD) questionnaire answers

  6. Change in the effect of Endoscopic Bariatric Therapies on reflux

    Time frame: Baseline, 6 months,and 1 year post procedure

    measuring change in ph measurement on ph manometry

  7. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Time frame: Baseline, 6 months,and 1 year post procedure

    Measuring change in fibroscan score

  8. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Time frame: Baseline, 6 months,and 1 year post procedure

    Measuring change in liver biopsy results

  9. Change in the effect of bariatric endoscopic procedure on individuals with fatty liver disease

    Time frame: Baseline, 6 months,and 1 year post procedure

    Measuring change in liver functions tests (on blood draw alanine alanine aminotransferase (ALT), AST (aspartate aminotransferase) )

Study contacts

Contact information is provided by the study sponsor or research team.

Andrea M Herr, NP

CONTACT

[email protected]

646-962-2382

Reem Z Sharaiha, MD, MSc.

CONTACT

[email protected]

646-962-2382

Sponsors and collaborators

Lead sponsor

Weill Medical College of Cornell University

Other

Registry information

Acronym: EBT

Important dates

Study start
2016
Primary completion
2035
Study completion
2035
First posted
Jul 31, 2020
Registry last updated
Apr 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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