GastroparesisNCT07526935
Combined Role of Gastric Peroral Endoscopic Myotomy and Gastric Electrical Stimulator
A study testing GES + Upper endoscopy, GES on + Upper endscopy and GES off + G-POEM in people with Gastroparesis, run by Baylor Research Institute at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gastroparesis
- What is being tested?
- GES + Upper endoscopy, GES on + Upper endscopy and GES off + G-POEM
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Mar 2025to 30 Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 join
- Patients with prior surgical intervention for gastroparesis
- Patients less than 18 years old
- Pregnant women
Trial locations and contacts
1 site in 1 country.
United States1 site
Baylor University Medical Center
Dallas, Texas, 75246
About this study
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
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.
- Conditions
- Gastroparesis
- Being tested
- GES + Upper endoscopy, GES on + Upper endscopy, GES off + G-POEM, GES on + G-POEM
- Medical subject headings
- Gastroparesis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GES + Upper endoscopyDevice
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 endscopyDevice
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-POEMProcedure or surgery
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-POEMProcedure or surgery
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 group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | GES off + Upper Endoscopy Receives: Device: GES + Upper endoscopy |
| GES only | Active comparator | GES on + Upper Endoscopy Receives: Device: GES on + Upper endscopy |
| G-POEM only | Active comparator | GES off + GPOEM Receives: Procedure: GES off + G-POEM |
| Combination G-POEM and GES | Active comparator | GES on + GPOEM Receives: Procedure: GES on + G-POEM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gastroparesis Symptom Changes
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).
Measured: Baseline, Preoperative 3 months, 6 months, 9 months, 12 months
Secondary outcomes (8)
Subjects quality of life
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).
Measured: Baseline, 6 months, 12 months.
Weight
Assessing changes in weight using clinical measurement
Measured: Baseline, 6 months, 12 months
BMI
Assessing changes in BMI using clinical measurement
Measured: Baseline, 6 months, 12 months
Nutritional Support Status
Assessing for need for tube feeds/TPN by referring to subjects medical records
Measured: Baseline, 6 months, 12 months
Gastroparesis-related hospitalizations
Evaluating rates of reintervention/hospitalizations due to surgical complications by referring to subjects medical records
Measured: 12 month follow-up
ED visits for symptoms
Evaluating number of ED visits, hospitalizations/readmissions due to gastroparesis by referring to subjects medical records
Measured: 12 month follow-up
Gastric Emptying
Evaluating gastric emptying as shown in 4-hour retention on gastric emptying scintigraphy using the nuclear medicine report
Measured: Baseline, 6 months, 12 months
Antiemetic/Prokinetic use
Evaluating changes to pharmacologic use by monitoring active medication use via subjects medical records
Measured: Baseline, 6 months, 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start19 Mar 2025
- Primary completion30 Dec 2028 (estimated)
- Study completion30 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Baylor Research InstituteThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Baylor Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Marc Ward, MD, Principal investigator, Baylor Health Care System
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526935
- Sponsor's protocol ID
- 024-238
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2026
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07526935
- Acronym / sponsor ID
- 024-238
- Conditions
- Gastroparesis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Baylor Research InstituteUniversity, hospital or other
- Study start
- 19 Mar 2025 (actual)
- Primary completion
- 30 Dec 2028 (estimated)
- Study completion
- 30 Dec 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Device: GES + Upper endoscopyGES off + Upper Endoscopy |
| GES only | Active comparator | Device: GES on + Upper endscopyGES on + Upper Endoscopy |
| G-POEM only | Active comparator | Procedure: GES off + G-POEMGES off + GPOEM |
| Combination G-POEM and GES | Active comparator | Procedure: GES on + G-POEMGES on + GPOEM |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (3 listed)
- Patients with prior surgical intervention for gastroparesis
- Patients less than 18 years old
- Pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GES + Upper endoscopyParticipants 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. | Device | Control group |
| GES on + Upper endscopyParticipants 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. | Device | GES only |
| GES off + G-POEMParticipants 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. | Procedure or surgery | G-POEM only |
| GES on + G-POEMParticipants 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. | Procedure or surgery | Combination G-POEM and GES |
Primary outcome
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).
8 secondary outcomes
Subjects quality of life
Time frame: Baseline, 6 months, 12 months.
Weight
Time frame: Baseline, 6 months, 12 months
BMI
Time frame: Baseline, 6 months, 12 months
Nutritional Support Status
Time frame: Baseline, 6 months, 12 months
Gastroparesis-related hospitalizations
Time frame: 12 month follow-up
ED visits for symptoms
Time frame: 12 month follow-up
Gastric Emptying
Time frame: Baseline, 6 months, 12 months
Antiemetic/Prokinetic use
Time frame: Baseline, 6 months, 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Ward, MD principal investigator
Baylor Health Care System
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing GES + Upper endoscopy, GES on + Upper endscopy and GES off + G-POEM in people with Gastroparesis, run by Baylor Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 30 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gastroparesis Symptom Changes (time frame: Baseline, Preoperative 3 months, 6 months, 9 months, 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Apr 2026.