GastroparesisNCT04869670
A Study to Evaluate Safety and Effectiveness of G-POEM for Gastroparesis
A study testing Gastric peroral endoscopic myotomy. in people with Gastroparesis, run by Mayo Clinic at 2 sites in United States.
Trial summary
The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Gastroparesis
- What is being tested?
- Gastric peroral endoscopic myotomy.
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 12 Jul 2023to 3 Mar 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
- Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
- Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
- Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
- No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.
Who cannot join
- Another active disorder which could explain symptoms in the opinion of the investigator.
- Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.
- Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
- Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
- Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
- New medications for gastroparesis-related symptoms started within 1 month prior to registration.
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- Pregnancy or nursing.
- Failure to give informed consent.
- Any other condition, which in the opinion of the investigator would impede compliance or hinder completion of the study.
- Botox injection into the pylorus within 3 months prior to registration.
- Allergy to eggs or Egg Beaters and Ensure.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Mayo Clinic
Rochester, Minnesota, 55905
Mayo Clinic Arizona
Scottsdale, Arizona, 85259
About this study
Official title: A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy
The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.
- Conditions
- Gastroparesis
- Being tested
- Gastric peroral endoscopic myotomy., Sham Gastric peroral endoscopic myotomy.
- Keywords
- Gastric Peroral Endoscopic Pyloromyotomy (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.
Gastric peroral endoscopic myotomy.Procedure or surgery
Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist.
Sham Gastric peroral endoscopic myotomy.Procedure or surgery
Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind.
| Study group | Role | What they receive |
|---|---|---|
| G-POEM | Experimental | Not described Receives: Procedure: Gastric peroral endoscopic myotomy. |
| Sham procedure | Sham comparator | Not described Receives: Procedure: Sham Gastric peroral endoscopic myotomy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
GCSI-DD Change
The effect of GPOEM on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. ANMS GCSI-DD evaluates five core symptoms: nausea, bloating, upper abdominal pain, stomach fullness and inability to finish a meal. Each symptom is rated 0-4 with 0= none, 1= mild, 2= moderate, 3= severe, and 4= very severe. The five responses are summed and divided by the number of responses completed to compute a total mean score range from 0-4, with higher scores indicating worse symptoms.
Measured: Baseline to 48 weeks post treatment
Secondary outcomes (1)
Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale
The effect of GPOEM on quality of life assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life (PAGI-QoL). The PAGI-QOL instrument consists of 30 items, each with response options based on a 6-point scale ranging from 0 (lowest QoL) to 5 (highest QoL) and with a recall period of the previous 2 weeks. The items are grouped into 5 dimensions: Daily Activities, Clothing, Diet and Food Habits, Relationship and Psychological Well-being and Distress. The 30 responses are summed and divided by the number of responses completed to compute a total mean score range of 0 to 5, with higher scores indicating better quality of life.
Measured: Baseline to 48 weeks post treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2021
- Study start12 Jul 2023
- Primary completion3 Mar 2025
- Study completion3 Mar 2025
Why it stopped: Inability to recruit patients for Sham controlled study; therefore, the study was terminated
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Responsible party
- Principal investigator, Michael Camilleri, MD, Mayo Clinic
- Investigators
- Michael Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04869670
- Sponsor's protocol ID
- 21-001928
- Other IDs
- R01DK125680
- Status last verified
- Apr 2026
- First submitted
- 22 Apr 2021
- Last updated
- 22 May 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot and Feasibility Trial of G-POEM for Gastroparesis to Assess Safety, Physiological Mechanisms and Efficacy
- ClinicalTrials.gov ID
- NCT04869670
- Acronym / sponsor ID
- 21-001928
- Conditions
- Gastroparesis
- Keywords
- Gastric Peroral Endoscopic Pyloromyotomy (G-POEM)
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inability to recruit patients for Sham controlled study; therefore, the study was terminated
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Johns Hopkins University, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- 12 Jul 2023 (actual)
- Primary completion
- 3 Mar 2025 (actual)
- Study completion
- 3 Mar 2025 (actual)
- First posted
- 3 May 2021 (actual)
- Results
- Posted 22 May 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research is to evaluate the 12-month treatment effect of peroral endoscopic pyloromyotomy (G-POEM) vs. sham surgery in patients with gastroparesis that is not helped by medications and to analyze factors that may predict the outcome of the surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| G-POEM | Experimental | Procedure: Gastric peroral endoscopic myotomy. |
| Sham procedure | Sham comparator | Procedure: Sham Gastric peroral endoscopic myotomy. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Symptoms of chronic nausea or vomiting compatible with gastroparesis (idiopathic or diabetic) must be present for at least one year (does not have to be contiguous) prior to registration.
- Must have a mean total Gastroparesis Cardinal Symptom Index (GCSI) score of ≥ 3 at screening visit.
- Refractory gastroparesis, defined using our previously published data5, as a failure to improve over the last 6 months, despite an adequate trial of one or more standard prokinetics (metoclopramide, erythromycin, prucalopride), antinauseants (5-HT3 antagonists, promethazine, prochlorperazine, dronabinol), or neuromodulators (mirtazapine, buspirone).
- Moderate to severe delay in gastric emptying, defined as > 25% solid retained at 4 hours or > 75% retained at 2 hours. The qualifying gastric emptying scintigraphy must be performed within 18 months prior to registration or can be the baseline gastric emptying.
- No evidence of mechanical obstruction based on upper GI endoscopy or upper GI series in their medical history.
Key exclusion criteria (11 listed)
- Another active disorder which could explain symptoms in the opinion of the investigator.
- Gastric retention of solids at 4 hours < 25% or < 75% at 2 hours.
- Ongoing use of prokinetic agents (e.g., metoclopramide, erythromycin, prucalopride) GLP -1 analog or agonists, or drugs that slow down gastric emptying (narcotics). Neuromodulators such as tricyclic antidepressants (amitriptyline or nortriptyline) or others that are being used at stable doses for a month prior to randomization may continue at the discretion of the care provider.
- Significant systemic illness such as chronic renal failure (adjusted for age) or liver disease as defined by Child-Pugh score of 10 or greater.
- Poorly controlled diabetes with HbA1c of greater than 10% at time of screening.
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 |
|---|---|---|
| Gastric peroral endoscopic myotomy.Under propofol anesthesia, EndoFLIP will be used to assess pyloric diameter and distensibility, prior to and after G-POEM, performed by an endoscopist skilled in this technique. After the procedure, the patient will be observed in the hospital for 2 days. Patients will undergo an upper GI series the next day to rule out perforation. If the patient develops a complication from the procedure, he or she will be managed per standard clinical practice by the treating (unblinded) endoscopist. | Procedure or surgery | G-POEM |
| Sham Gastric peroral endoscopic myotomy.Patients assigned to the sham procedure will be treated identically as above, except for the performance of the G-POEM. Endoscopy and EndoFLIP will be performed and sedation will be stopped when the upper endoscopy is completed. Since sham endoscopy is expected to take less time than G-POEM, the patient should remain in the endoscopy procedure room for a minimum of 30 minutes (including the time required to complete the upper endoscopy). After the procedure, the patient will be observed in the hospital for 2 days. All patients will undergo an upper GI series radiographic examination the next day to rule out perforation in order to maintain study blind. | Procedure or surgery | Sham procedure |
Primary outcome
GCSI-DD Change
Time frame: Baseline to 48 weeks post treatment
The effect of GPOEM on nausea, early satiety, postprandial fullness, and upper abdominal pain as per changes in patient scoring in The American Neurogastroenterology and Motility Society Gastroparesis Cardinal Symptom Index Daily Diary (ANMS GCSI-DD) which has been designed to assess symptoms associated with gastroparesis. ANMS GCSI-DD evaluates five core symptoms: nausea, bloating, upper abdominal pain, stomach fullness and inability to finish a meal. Each symptom is rated 0-4 with 0= none, 1= mild, 2= moderate, 3= severe, and 4= very severe. The five responses are summed and divided by the number of responses completed to compute a total mean score range from 0-4, with higher scores indicating worse symptoms.
1 secondary outcome
Change in Quality of Life as Assessed by the Patient Assessment of Upper Gastrointestinal Disorders-Quality of Life Scale
Time frame: Baseline to 48 weeks post treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Mayo Clinic Clinical TrialsLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Michael Camilleri, MD principal investigator
Mayo Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Gastric peroral endoscopic myotomy. in people with Gastroparesis, run by Mayo Clinic at 2 sites 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 5 inclusion and 11 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: stopped early, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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. Some participants in this study may receive a placebo. 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?
Yes. Results are posted in the registry (first posted 22 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
GCSI-DD Change (time frame: Baseline to 48 weeks post treatment). 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 22 May 2026.