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Impact of Endoscopic Sleeve Gastroplasty (ESG) in Obese Adults With Type 2 Diabetes (T2D)

NCT07639684 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2026-07-24

No results posted yet for this study

Summary

The goal of this clinical trial is to determine whether Endoscopic Sleeve Gastroplasty (ESG)-induced weight loss can improve glycemic outcomes and alter the trajectory toward insulin dependence in adults with obesity and inadequately controlled Type 2 Diabetes (T2D) despite guideline-directed therapy, including Glucagon-Like Peptide-1 Receptor Agonists (GLP-1RA)-based agents.

Conditions

  • Type 2 Diabetes Mellitus (T2D)
  • Obesity (BMI>30)

Interventions

DEVICE

ESG with OverStitch

Endoscopic Sleeve Gastroplasty (ESG) with OverStitch Endoscopic Suturing System.

Sponsors & Collaborators

  • Boston Scientific Corporation

    lead INDUSTRY

Principal Investigators

  • Ildiko Lingvay, MD · UT Southwestern

  • Shailendra Singh, MD · West Virginia University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2027-02-28
Primary Completion
2029-05-31
Completion
2029-05-31
FDA Device
Yes

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07639684 on ClinicalTrials.gov