NCT04494048

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 1 years after a subject consents for study participation.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9,999

participants targeted

Target at P75+ for all trials

Timeline
115mo left

Started Apr 2016

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress52%
Apr 2016Oct 2035

Study Start

First participant enrolled

April 5, 2016

Completed
4.1 years until next milestone

First Submitted

Initial submission to the registry

May 13, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

July 31, 2020

Completed
15.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2035

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2035

Last Updated

April 23, 2026

Status Verified

April 1, 2026

Enrollment Period

19.6 years

First QC Date

May 13, 2020

Last Update Submit

April 21, 2026

Conditions

Gastro Esophageal RefluxBariatric Surgery CandidateObesityWeight Loss

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (9)

  • Technical success of each bariatric therapy.

    through study completion at one year.

  • Change and Improvement in comorbidities

    6 months, 1 year post procedure

  • Change and Improvement in comorbidities

    6 months, 1 year post procedure

  • Change and Improvement in comorbidities

    6 months, 1 year post procedure

  • Change in the effect of Endoscopic Bariatric Therapies on reflux

    Baseline, 6 months,and 1 year post procedure

  • +4 more secondary outcomes

Study Arms (1)

Endoscopic Bariatric Therapies (EBT).

patients undergoing Endoscopic Bariatric Therapies

Other: Endoscopic Bariatric Therapies

Interventions

Endoscopic Bariatric TherapiesOTHER

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

Endoscopic Bariatric Therapies (EBT).

Eligibility Criteria

Age18 Years - 89 Years
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Individuals who will undergo Endoscopic bariatric therapies.

You may qualify if:

  • 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.

You may not qualify if:

  • Any patient who has not undergone or will undergo EBT for weight loss
  • Below 18 years of age.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medicine

New York, New York, 10021, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 39694295DERIVED

MeSH Terms

Conditions

ObesityWeight LossGastroesophageal Reflux

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsBody Weight ChangesEsophageal Motility DisordersDeglutition DisordersEsophageal DiseasesGastrointestinal DiseasesDigestive System Diseases

Study Officials

  • Reem Z Sharaiha, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Reem Z Sharaiha, MD, MSc.

CONTACT

646-962-2382rzs9001@med.cornell.edu

Andrea M Herr, NP

CONTACT

646-962-2382anb9057@med.cornell.edu

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 13, 2020

First Posted

July 31, 2020

Study Start

April 5, 2016

Primary Completion (Estimated)

October 31, 2035

Study Completion (Estimated)

October 31, 2035

Last Updated

April 23, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)