GastroparesisCOMET-GPNCT06173336
Comparison of Outcomes for Single vs Double Pyloromyotomy for Gastroparesis Randomized Controlled Trial
A study testing gastric per-oral endoscopic myotomy (G-POEM) in people with Gastroparesis, run by University of Arkansas.
Trial summary
Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort Gastroparesis cardinal symptoms index (GCSI) is a reliable… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- What is being tested?
- gastric per-oral endoscopic myotomy (G-POEM)
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 17 Jun 2025to 17 Jun 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients with refractory (persistent symptoms for >6 months refractory to medical therapy) and severe gastroparesis based on GCSI > 2, with confirmed im-paired gastric emptying based on gastric emptying.
- Persons 18 years or older at the time of signing the informed consent
Who cannot join
- No previous attempt with at least one prokinetic drug.
- Previous gastric surgery.
- Esophageal or gastric varices and /or portal gastropathy.
- Pregnant patients.
- Malignant or pre-malignant gastric diseases.
About this study
Official title: A Randomized Controlled Prospective Trial Comparing Clinical Outcomes and Efficacy of Single vs. Double Pyloromyotomy Technique for Gastric Peroral Endoscopic Pyloromyotomy (G-POEM) in the Treatment of Gastroparesis
Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort Gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis.
This will be a randomized controlled trial of all the patients who are referred to the University of Arkansas Medical Sciences (UAMS) for gastric peroral endoscopic pyloromyotomy (G-POEM) for treatment of refractory and severe gastroparesis. During G-POEM procedure, either single or double pyloromyotomy will be performed with randomization. The aim is to compare clinical outcomes and the efficacy of single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.
Read the detailed description
Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. It is a chronic alteration of gastric motility that leads to a delay in stomach emptying. It is an underdiagnosed condition. The prevalence is estimated at around 3% in the United States (mean age of 37.7 years, with an F: M ratio of 4:1. It is mainly an idiopathic condition; however, it can also be caused by diabetes mellitus and post-surgical conditions, such as fundoplication, vagotomy, bariatric surgery, and esophagectomy. Less frequently by conditions like post-infectious gastro-paresis, neurological or autoimmune diseases. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort. The gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis. It is based on three sub-scales (post-prandial fullness/early satiety-4 items; nausea/vomiting-3 items; bloating-2 items), and each item ranges from 0 (none) to 5 (severe). GCSI is not a diagnostic tool, but it is helpful to measure the severity of the disease and the post-treatment improvement. Though the prevalence of gastroparesis has significantly increased over the last decade, management is still challenging. Patients with mild symptoms can be referred for dietary modifications coupled with medical therapy with prokinetics, especially metoclopramide. However, the response to prokinetics decreases over time. Moreover, these drugs have side effects, such as extrapyramidal symptoms and amenorrhea. Surgical approaches have been proposed; however, the invasive nature of those procedures and the low rate of clinical success have made them less favorable. Endoscopic interventions have also been described, including intra-pyloric injection of botulinum toxin, endoscopic gastrojejunostomy, and transpyloric stenting. For patients with refractory (persistent symptoms for >6 months refractory to medical therapy) and severe gastroparesis based on GCSI > 2, gastric per-oral endoscopic myotomy can be considered. In 2013, the first human gastric per-oral endoscopic myotomy (G-POEM) was performed. It was inspired by the per-oral endoscopic myotomy technique, with a similar dissection method, that allows pyloromyotomy. The technical steps of G-POEM involve mucosal incision about 5 cm from the pylorus with the creation of access to the submucosal plane after detaching the planes by injection of lifting solution; creation of the submucosal tunnel with dissection technique up to the duodenal bulb and exposure of the pylorus; verification of the integrity of the mucosal surface; pyloromyotomy and closure of the mucosal flap with multiple endoclips. In the single pyloromyotomy group, a selective circular pyloromyotomy is performed at the 6 or 7 o'clock position after identifying the pyloric ring. In the double pyloromyotomy group, another selective cut is performed at the 4 or 5 o'clock position to keep at least 1 cm between the two pyloromyotomies.
Only one retrospective case-controlled study compares single versus double pyloromyotomy at G-POEM for refractory gastroparesis. It showed a higher clinical response rate with double pyloromyotomy when compared with single pyloromyotomy in a 3- to 6-month follow-up period.
In this randomized controlled prospective multicenter study, the aim is to compare clinical outcomes and the efficacy of single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis. Prospective subjects will be approached regarding study inclusion either during a pre-endoscopy visit or shortly before the planned endoscopy procedure. If the latter, the prospective subject will be approached during intake and before being brought to the back for the procedure. The prospective subjects will be approached before any pre-procedure medication is administered. The study will be explained in detail and, if the prospective participant agrees, an informed consent form - HIPAA Research Authorization will be taken.
Prospective subjects will be randomized into one of two study groups: Single pyloromyotomy vs Double pyloromyotomy G-POEM using a computer-generated random sequence (prepared by the UAMS Biostatistics group) that will be placed in sealed envelopes. The envelopes will accompany the informed consent form will be opened after obtaining informed consent from the patients to determine their group assignment. The patient will open the envelop and hand it to the endoscopist performing the procedure.
Once randomized, the subjects will undergo the scheduled endoscopic procedure as planned.
Subjects will be followed up in the clinic at 3 months, 6 months, and 12 months (one year) after procedure per routine care.
- Conditions
- Gastroparesis
- Being tested
- gastric per-oral endoscopic myotomy (G-POEM)
- Keywords
- Gastric Per-Oral Endoscopic Myotomy (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 per-oral endoscopic myotomy (G-POEM)Procedure or surgery
Comparing single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.
| Study group | Role | What they receive |
|---|---|---|
| Single pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM) | Active comparator | Single cut pyloromyotomy technique during gastric per-oral endoscopic myotomy (G-POEM) procedure Receives: Procedure: gastric per-oral endoscopic myotomy (G-POEM) |
| Double pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM) | Active comparator | Double cut pyloromyotomy technique during gastric per-oral endoscopic myotomy (G-POEM) procedure Receives: Procedure: gastric per-oral endoscopic myotomy (G-POEM) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical success at 3 months, 6 months and 12 months follow up
Measuring clinical success
Measured: 3, 6 and 12 months
Gastroparesis Cardinal Symptom Index (GCSI) score before and after GPOEM at 3, 6 months and 12 months follow up
Measuring GCSI scores
Measured: 3, 6 and 12 months
Technical success rate
Measuring technical success
Measured: At time of procedure
Secondary outcomes (3)
Total procedure time for each method
Documenting total time to perform procedure
Measured: At time of procedure
Adverse events like pneumoperitoneum, gi bleeding, perforation, infection and abdominal pain
Adverse events with both techniques
Measured: 0 and1 month
Recurrence of symptoms
Any recurrence of gastroparesis symptoms
Measured: 3, 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start17 Jun 2025
- Primary completion17 Jun 2025
- Study completion17 Jun 2025
Why it stopped: Study never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by University of ArkansasThe 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
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arkansas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sumant Inamdar, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06173336
- Sponsor's protocol ID
- 275425
- Acronym
- COMET-GP
- Status last verified
- Sep 2024
- First submitted
- 7 Dec 2023
- Last updated
- 25 Jun 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jung HK, Choung RS, Locke GR 3rd, Schleck CD, Zinsmeister AR, Szarka LA, Mullan B, Talley NJ. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009 Apr;136(4):1225-33. doi: 10.1053/j.gastro.2008.12.047. Epub 2008 Dec 24.
PubMed 19249393Verga MC, Mazza S, Azzolini F, Cereatti F, Conti CB, Drago A, Soro S, Elvo B, Grassia R. Gastric per-oral endoscopic myotomy: Indications, technique, results and comparison with surgical approach. World J Gastrointest Surg. 2022 Jan 27;14(1):12-23. doi: 10.4240/wjgs.v14.i1.12.
PubMed 35126859Camilleri M, Chedid V, Ford AC, Haruma K, Horowitz M, Jones KL, Low PA, Park SY, Parkman HP, Stanghellini V. Gastroparesis. Nat Rev Dis Primers. 2018 Nov 1;4(1):41. doi: 10.1038/s41572-018-0038-z.
PubMed 30385743Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Gastroparesis Cardinal Symptom Index (GCSI): development and validation of a patient reported assessment of severity of gastroparesis symptoms. Qual Life Res. 2004 May;13(4):833-44. doi: 10.1023/B:QURE.0000021689.86296.e4.
PubMed 15129893Lacy BE, Parkman HP, Camilleri M. Chronic nausea and vomiting: evaluation and treatment. Am J Gastroenterol. 2018 May;113(5):647-659. doi: 10.1038/s41395-018-0039-2. Epub 2018 Mar 15.
PubMed 29545633Hirsch W, Nee J, Ballou S, Petersen T, Friedlander D, Lee HN, Cheng V, Lembo A. Emergency Department Burden of Gastroparesis in the United States, 2006 to 2013. J Clin Gastroenterol. 2019 Feb;53(2):109-113. doi: 10.1097/MCG.0000000000000972.
PubMed 29256990Rao AS, Camilleri M. Review article: metoclopramide and tardive dyskinesia. Aliment Pharmacol Ther. 2010 Jan;31(1):11-9. doi: 10.1111/j.1365-2036.2009.04189.x.
PubMed 19886950Ahuja NK, Clarke JO. Pyloric Therapies for Gastroparesis. Curr Treat Options Gastroenterol. 2017 Mar;15(1):230-240. doi: 10.1007/s11938-017-0124-4.
PubMed 28124202Aghaie Meybodi M, Qumseya BJ, Shakoor D, Lobner K, Vosoughi K, Ichkhanian Y, Khashab MA. Efficacy and feasibility of G-POEM in management of patients with refractory gastroparesis: a systematic review and meta-analysis. Endosc Int Open. 2019 Mar;7(3):E322-E329. doi: 10.1055/a-0812-1458. Epub 2019 Feb 28.
PubMed 30842971Khashab MA, Stein E, Clarke JO, Saxena P, Kumbhari V, Chander Roland B, Kalloo AN, Stavropoulos S, Pasricha P, Inoue H. Gastric peroral endoscopic myotomy for refractory gastroparesis: first human endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2013 Nov;78(5):764-8. doi: 10.1016/j.gie.2013.07.019. No abstract available.
PubMed 24120337Abdelfatah MM, Li B, Kapil N, Noll A, Li L, Luo H, Chen H, Xia L, Chen X, Patel V, Mekaroonkamol P, Massaad J, Keilin S, Cai Q. Short-term outcomes of double versus single pyloromyotomy at peroral endoscopic pyloromyotomy in the treatment of gastroparesis (with video). Gastrointest Endosc. 2020 Sep;92(3):603-609. doi: 10.1016/j.gie.2020.01.016. Epub 2020 Jan 17.
PubMed 31958460
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Prospective Trial Comparing Clinical Outcomes and Efficacy of Single vs. Double Pyloromyotomy Technique for Gastric Peroral Endoscopic Pyloromyotomy (G-POEM) in the Treatment of Gastroparesis
- ClinicalTrials.gov ID
- NCT06173336
- Acronym / sponsor ID
- COMET-GP / 275425
- Conditions
- Gastroparesis
- Keywords
- Gastric Per-Oral Endoscopic Myotomy (G-POEM)
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Study never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of ArkansasUniversity, hospital or other
- Study start
- 17 Jun 2025 (actual)
- Primary completion
- 17 Jun 2025 (actual)
- Study completion
- 17 Jun 2025 (actual)
- First posted
- 15 Dec 2023 (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.
Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort Gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis.
This will be a randomized controlled trial of all the patients who are referred to the University of Arkansas Medical Sciences (UAMS) for gastric peroral endoscopic pyloromyotomy (G-POEM) for treatment of refractory and severe gastroparesis. During G-POEM procedure, either single or double pyloromyotomy will be performed with randomization. The aim is to compare clinical outcomes and the efficacy of single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis.
Detailed description
Gastroparesis is a chronic disease of the stomach that causes delayed gastric emptying without stenosis. It is a chronic alteration of gastric motility that leads to a delay in stomach emptying. It is an underdiagnosed condition. The prevalence is estimated at around 3% in the United States (mean age of 37.7 years, with an F: M ratio of 4:1. It is mainly an idiopathic condition; however, it can also be caused by diabetes mellitus and post-surgical conditions, such as fundoplication, vagotomy, bariatric surgery, and esophagectomy. Less frequently by conditions like post-infectious gastro-paresis, neurological or autoimmune diseases. The clinical symptoms of gastroparesis include nausea, vomiting, early satiety, post-prandial fullness, bloating, belching, and upper abdominal discomfort. The gastroparesis cardinal symptoms index (GCSI) is a reliable, reproducible, and valid instrument for measuring symptom severity in patients with gastroparesis. It is based on three sub-scales (post-prandial fullness/early satiety-4 items; nausea/vomiting-3 items; bloating-2 items), and each item ranges from 0 (none) to 5 (severe). GCSI is not a diagnostic tool, but it is helpful to measure the severity of the disease and the post-treatment improvement. Though the prevalence of gastroparesis has significantly increased over the last decade, management is still challenging. Patients with mild symptoms can be referred for dietary modifications coupled with medical therapy with prokinetics, especially metoclopramide. However, the response to prokinetics decreases over time. Moreover, these drugs have side effects, such as extrapyramidal symptoms and amenorrhea. Surgical approaches have been proposed; however, the invasive nature of those procedures and the low rate of clinical success have made them less favorable. Endoscopic interventions have also been described, including intra-pyloric injection of botulinum toxin, endoscopic gastrojejunostomy, and transpyloric stenting. For patients with refractory (persistent symptoms for >6 months refractory to medical therapy) and severe gastroparesis based on GCSI > 2, gastric per-oral endoscopic myotomy can be considered. In 2013, the first human gastric per-oral endoscopic myotomy (G-POEM) was performed. It was inspired by the per-oral endoscopic myotomy technique, with a similar dissection method, that allows pyloromyotomy. The technical steps of G-POEM involve mucosal incision about 5 cm from the pylorus with the creation of access to the submucosal plane after detaching the planes by injection of lifting solution; creation of the submucosal tunnel with dissection technique up to the duodenal bulb and exposure of the pylorus; verification of the integrity of the mucosal surface; pyloromyotomy and closure of the mucosal flap with multiple endoclips. In the single pyloromyotomy group, a selective circular pyloromyotomy is performed at the 6 or 7 o'clock position after identifying the pyloric ring. In the double pyloromyotomy group, another selective cut is performed at the 4 or 5 o'clock position to keep at least 1 cm between the two pyloromyotomies.
Only one retrospective case-controlled study compares single versus double pyloromyotomy at G-POEM for refractory gastroparesis. It showed a higher clinical response rate with double pyloromyotomy when compared with single pyloromyotomy in a 3- to 6-month follow-up period.
In this randomized controlled prospective multicenter study, the aim is to compare clinical outcomes and the efficacy of single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis. Prospective subjects will be approached regarding study inclusion either during a pre-endoscopy visit or shortly before the planned endoscopy procedure. If the latter, the prospective subject will be approached during intake and before being brought to the back for the procedure. The prospective subjects will be approached before any pre-procedure medication is administered. The study will be explained in detail and, if the prospective participant agrees, an informed consent form - HIPAA Research Authorization will be taken.
Prospective subjects will be randomized into one of two study groups: Single pyloromyotomy vs Double pyloromyotomy G-POEM using a computer-generated random sequence (prepared by the UAMS Biostatistics group) that will be placed in sealed envelopes. The envelopes will accompany the informed consent form will be opened after obtaining informed consent from the patients to determine their group assignment. The patient will open the envelop and hand it to the endoscopist performing the procedure.
Once randomized, the subjects will undergo the scheduled endoscopic procedure as planned.
Subjects will be followed up in the clinic at 3 months, 6 months, and 12 months (one year) after procedure per routine care.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM) | Active comparator | Procedure: gastric per-oral endoscopic myotomy (G-POEM)Single cut pyloromyotomy technique during gastric per-oral endoscopic myotomy (G-POEM) procedure |
| Double pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM) | Active comparator | Procedure: gastric per-oral endoscopic myotomy (G-POEM)Double cut pyloromyotomy technique during gastric per-oral endoscopic myotomy (G-POEM) procedure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients with refractory (persistent symptoms for >6 months refractory to medical therapy) and severe gastroparesis based on GCSI > 2, with confirmed im-paired gastric emptying based on gastric emptying.
- Persons 18 years or older at the time of signing the informed consent
Key exclusion criteria (5 listed)
- No previous attempt with at least one prokinetic drug.
- Previous gastric surgery.
- Esophageal or gastric varices and /or portal gastropathy.
- Pregnant patients.
- Malignant or pre-malignant gastric diseases.
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 per-oral endoscopic myotomy (G-POEM)Comparing single versus double pyloromyotomy in G-POEM for refractory and severe gastroparesis. | Procedure or surgery | Double pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM), Single pyloromyotomy gastric per-oral endoscopic myotomy (G-POEM) |
Primary outcome
Clinical success at 3 months, 6 months and 12 months follow up
Time frame: 3, 6 and 12 months
Measuring clinical success
Gastroparesis Cardinal Symptom Index (GCSI) score before and after GPOEM at 3, 6 months and 12 months follow up
Time frame: 3, 6 and 12 months
Measuring GCSI scores
Technical success rate
Time frame: At time of procedure
Measuring technical success
3 secondary outcomes
Total procedure time for each method
Time frame: At time of procedure
Adverse events like pneumoperitoneum, gi bleeding, perforation, infection and abdominal pain
Time frame: 0 and1 month
Recurrence of symptoms
Time frame: 3, 6 and 12 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2025.
- Results publication: PubMed 19249393Jung HK, Choung RS, Locke GR 3rd, Schleck CD, Zinsmeister AR, Szarka LA, Mullan B, Talley NJ. The incidence, prevalence, and outcomes of patients with gastroparesis in Olmsted County, Minnesota, from 1996 to 2006. Gastroenterology. 2009 Apr;136(4):1225-33. doi: 10.1053/j.gastro.2008.12.047. Epub 2008 Dec 24.
- Results publication: PubMed 35126859Verga MC, Mazza S, Azzolini F, Cereatti F, Conti CB, Drago A, Soro S, Elvo B, Grassia R. Gastric per-oral endoscopic myotomy: Indications, technique, results and comparison with surgical approach. World J Gastrointest Surg. 2022 Jan 27;14(1):12-23. doi: 10.4240/wjgs.v14.i1.12.
- Results publication: PubMed 30385743Camilleri M, Chedid V, Ford AC, Haruma K, Horowitz M, Jones KL, Low PA, Park SY, Parkman HP, Stanghellini V. Gastroparesis. Nat Rev Dis Primers. 2018 Nov 1;4(1):41. doi: 10.1038/s41572-018-0038-z.
- Results publication: PubMed 15129893Revicki DA, Rentz AM, Dubois D, Kahrilas P, Stanghellini V, Talley NJ, Tack J. Gastroparesis Cardinal Symptom Index (GCSI): development and validation of a patient reported assessment of severity of gastroparesis symptoms. Qual Life Res. 2004 May;13(4):833-44. doi: 10.1023/B:QURE.0000021689.86296.e4.
- Results publication: PubMed 29545633Lacy BE, Parkman HP, Camilleri M. Chronic nausea and vomiting: evaluation and treatment. Am J Gastroenterol. 2018 May;113(5):647-659. doi: 10.1038/s41395-018-0039-2. Epub 2018 Mar 15.
- Results publication: PubMed 29256990Hirsch W, Nee J, Ballou S, Petersen T, Friedlander D, Lee HN, Cheng V, Lembo A. Emergency Department Burden of Gastroparesis in the United States, 2006 to 2013. J Clin Gastroenterol. 2019 Feb;53(2):109-113. doi: 10.1097/MCG.0000000000000972.
- Results publication: PubMed 19886950Rao AS, Camilleri M. Review article: metoclopramide and tardive dyskinesia. Aliment Pharmacol Ther. 2010 Jan;31(1):11-9. doi: 10.1111/j.1365-2036.2009.04189.x.
- Results publication: PubMed 28124202Ahuja NK, Clarke JO. Pyloric Therapies for Gastroparesis. Curr Treat Options Gastroenterol. 2017 Mar;15(1):230-240. doi: 10.1007/s11938-017-0124-4.
- Results publication: PubMed 30842971Aghaie Meybodi M, Qumseya BJ, Shakoor D, Lobner K, Vosoughi K, Ichkhanian Y, Khashab MA. Efficacy and feasibility of G-POEM in management of patients with refractory gastroparesis: a systematic review and meta-analysis. Endosc Int Open. 2019 Mar;7(3):E322-E329. doi: 10.1055/a-0812-1458. Epub 2019 Feb 28.
- Results publication: PubMed 24120337Khashab MA, Stein E, Clarke JO, Saxena P, Kumbhari V, Chander Roland B, Kalloo AN, Stavropoulos S, Pasricha P, Inoue H. Gastric peroral endoscopic myotomy for refractory gastroparesis: first human endoscopic pyloromyotomy (with video). Gastrointest Endosc. 2013 Nov;78(5):764-8. doi: 10.1016/j.gie.2013.07.019. No abstract available.
- Results publication: PubMed 31958460Abdelfatah MM, Li B, Kapil N, Noll A, Li L, Luo H, Chen H, Xia L, Chen X, Patel V, Mekaroonkamol P, Massaad J, Keilin S, Cai Q. Short-term outcomes of double versus single pyloromyotomy at peroral endoscopic pyloromyotomy in the treatment of gastroparesis (with video). Gastrointest Endosc. 2020 Sep;92(3):603-609. doi: 10.1016/j.gie.2020.01.016. Epub 2020 Jan 17.
- 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.
Sumant Inamdar, MD principal investigator
University of Arkansas
Questions about this trial
What is this clinical trial studying?
A study testing gastric per-oral endoscopic myotomy (G-POEM) in people with Gastroparesis, run by University of Arkansas.
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 2 inclusion and 5 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: withdrawn, as of the sponsor's last update on 25 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Clinical success at 3 months, 6 months and 12 months follow up (time frame: 3, 6 and 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06173336, which also lists 11 linked publications.
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 25 Jun 2025.