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Trial Investigating Efficacy of G-POEM

NCT05830994 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2023-04-26

No results posted yet for this study

Summary

The goal of this randomized sham-controlled trial is to ivestigate efficacy and safety of G-POEM in treatment of diabetic gastroparesis and explore impact of G-POEM on glucose metabolism and incretine hormones.

Conditions

  • Gastroparesis With Diabetes Mellitus

Interventions

PROCEDURE

G-POEM

An Endoscopic submucosal tunnel is formed and extended to the first part of the duodenum, followed by a pyloromyotomy, beginning approximately two centimetres proximal to the pylorus and ending in the first part of duodenum.

PROCEDURE

Sham

Endoscopy is performed and tissue samples are collected from fundus and antrum as part of the Sham procedure

Sponsors & Collaborators

  • Zealand University Hospital

    collaborator OTHER

  • Steno Diabetes Center Copenhagen

    collaborator OTHER

  • Hvidovre University Hospital

    lead OTHER

Principal Investigators

  • John G Karstensen, MD · Copenhagen University Hospital, Hvidovre

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-12
Primary Completion
2025-06-01
Completion
2025-06-01

Countries

  • Denmark

Study Locations

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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 NCT05830994 on ClinicalTrials.gov