Active, not recruitingNo phase
Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator
Key facts
- Who runs it
- Baylor Research Institute
- Where
- Dallas, United StatesSee the site
- Trial code
- Status
- Active, not recruiting
- People taking part
- 40 people, planned
- Started
- 19 Mar 2025
- Expected to end
- 30 Dec 2028
- Type of study
- Interventional, 4 groupsOne group gets an existing treatment, for comparison.
- Treatments tested
- GES + Upper endoscopy
- GES on + Upper endscopy
- GES off + G-POEM
- GES on + G-POEM
- Record updated
- 30 April 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 10 criteriaShow less
Who can take part
- Adult patients of age 18 years and older
- Patients must be able to consent
- Documented diagnosis of refractory GP as determined by the following criteria:
- Medically refractory GP symptoms for > 1 year despite treatment with first-line modalities and pharmacotherapies with anti-emetics and prokinetics AND
- Gastric emptying scintigraphy showing delayed gastric emptying with retention of >60% at 2h and/or greater than 10% at 4h based on standardized radionuclide solid meal test
- Preoperative Gastroparesis Cardinal Symptom Index (GCSI) Score
- A decision to treat patient with surgical therapy of G-POEM and/or electric stimulator
Who cannot take part
- Patients with prior surgical intervention for gastroparesis
- Patients less than 18 years old
- Pregnant women
Where in United States
- Baylor University Medical CenterDallas, United StatesNo longer taking part
About the trial
What the trial wants to find out
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.
The 4 groups in the trial
- Control groupExisting treatment, for comparison
GES off + Upper Endoscopy
Treatment: GES + Upper endoscopy
- GES onlyExisting treatment, for comparison
GES on + Upper Endoscopy
Treatment: GES on + Upper endscopy
- G-POEM onlyExisting treatment, for comparison
GES off + GPOEM
Treatment: GES off + G-POEM
- Combination G-POEM and GESExisting treatment, for comparison
GES on + GPOEM
Treatment: GES on + G-POEM
Data and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator in the Management of Refractory Gastroparesis- A Randomized Single Blinded Control Trial
- Record updated
- 30 April 2026