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NCT Number: NCT07526935

Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Gastroparesis Digestive System Diseases Gastrointestinal Diseases Neurologic Manifestations Paralysis Pathological Conditions, Signs and Symptoms Signs and Symptoms Stomach Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Baylor University Medical Center

Dallas, Texas, 75246, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Gastroparesis Symptom Changes

    Time frame: Baseline, Preoperative 3 months, 6 months, 9 months, 12 months

    Monitoring changes in gastroparesis symptom severity as measured by the Gastroparesis Cardinal Symptom Index (GCSI). A 9-item patient reported questionnaire with a rating scale of 0-5 ranging from 0 (none) to 5 (very severe).

Secondary outcomes

  1. Subjects quality of life

    Time frame: Baseline, 6 months, 12 months.

    Measuring changes to Quality of Life as measured by the 36-Item Short Form Survey (SF-36). A self-reported tool consisting of 36 questions with a rating scale of 0 (worst health) to 100 (best health).

  2. Weight

    Time frame: Baseline, 6 months, 12 months

    Assessing changes in weight using clinical measurement

  3. BMI

    Time frame: Baseline, 6 months, 12 months

    Assessing changes in BMI using clinical measurement

  4. Nutritional Support Status

    Time frame: Baseline, 6 months, 12 months

    Assessing for need for tube feeds/TPN by referring to subjects medical records

  5. Gastroparesis-related hospitalizations

    Time frame: 12 month follow-up

    Evaluating rates of reintervention/hospitalizations due to surgical complications by referring to subjects medical records

  6. ED visits for symptoms

    Time frame: 12 month follow-up

    Evaluating number of ED visits, hospitalizations/readmissions due to gastroparesis by referring to subjects medical records

  7. Gastric Emptying

    Time frame: Baseline, 6 months, 12 months

    Evaluating gastric emptying as shown in 4-hour retention on gastric emptying scintigraphy using the nuclear medicine report

  8. Antiemetic/Prokinetic use

    Time frame: Baseline, 6 months, 12 months

    Evaluating changes to pharmacologic use by monitoring active medication use via subjects medical records

Sponsors and collaborators

Lead sponsor

Baylor Research Institute

Other

Registry information

Official study title

Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator in the Management of Refractory Gastroparesis- A Randomized Single Blinded Control Trial

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Apr 30, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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