Active — Not RecruitingNot Applicable

Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator

United States40 participantsStarted 2025-03-19

Plain-language summary

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 can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Patients with prior surgical intervention for gastroparesis * Patients less than 18 years old * Pregnant women

What they're measuring

Gastroparesis Symptom Changes

Timeframe: Baseline, Preoperative 3 months, 6 months, 9 months, 12 months

Trial details

NCT IDNCT07526935

SponsorBaylor Research Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2028-12-30

View on ClinicalTrials.gov More Gastroparesis trials