Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator

Part of paid clinical trials in Dallas, Texas.

Sponsor
Baylor Research Institute
Study ID
NCT07526935
Status
Active Not Recruiting

Conditions

  • Gastroparesis

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • GES + Upper endoscopy — DEVICE
    Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement), without undergoing G-POEM. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.
  • GES on + Upper endscopy — DEVICE
    Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement), without undergoing G-POEM. The stimulator will stay on for the first 6 months and will then be turned off for the following 6 months.
  • GES off + G-POEM — PROCEDURE
    Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement) and G-POEM surgery. The stimulator will remain off for the first 6 months and will then be turned on for the following 6 months.
  • GES on + G-POEM — PROCEDURE
    Participants will receive implantation of a gastric electrical stimulator (GES) with upper endoscopy (which is routine during GES placement) and G-POEM. POEM. The stimulator will stay on for the first 6 months and will then be turned on for the following 6 months.

Study Details

This study is looking at how safe and effective G-POEM, GES and a combination of both are for people with severe stomach problems (gastroparesis) that haven't gotten better with medicine.

Key Dates

Start date
Mar 19, 2025
Status verified
Apr 2026
Primary completion
Dec 30, 2028
Completion
Dec 30, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Control group
    GES off + Upper Endoscopy
  • Active Comparator: GES only
    GES on + Upper Endoscopy
  • Active Comparator: G-POEM only
    GES off + GPOEM
  • Active Comparator: Combination G-POEM and GES
    GES on + GPOEM

Primary Outcome Measure

Gastroparesis Symptom Changes [ Time Frame: Baseline, Preoperative 3 months, 6 months, 9 months, 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
Baylor University Medical CenterDallasTexas75246-

Find similar trials in Dallas, TX

By research site
Baylor University Medical Center· Dallas, TX

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