G-POEM + GES for Gastroparesis

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Baylor Research Institute
Must be taking: Anti-emetics, Prokinetics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

MW

Marc Ward, MD

Principal Investigator

Baylor Health Care System

Are You a Good Fit for This Trial?

Inclusion Criteria

* Patients must be able to consent
I have had gastroparesis symptoms for over a year that did not improve with standard treatments.
* Preoperative Gastroparesis Cardinal Symptom Index (GCSI) Score
See 2 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive G-POEM, GES, or a combination of both for gastroparesis management

12 months
Regular visits at baseline, 3, 6, 9, and 12 months

Follow-up

Participants are monitored for changes in gastroparesis symptoms, nutritional support status, and quality of life

12 months
Follow-up assessments at 6 and 12 months

What Are the Treatments Tested in This Trial?

Interventions

  • GES
  • G-POEM

How Is the Trial Designed?

4

Treatment groups

Active Control

Group I: GES onlyActive Control1 Intervention
Group II: Combination G-POEM and GESActive Control1 Intervention
Group III: Control groupActive Control1 Intervention
Group IV: G-POEM onlyActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Baylor Research Institute

Lead Sponsor

Trials
210
Recruited
205,000+