GastroparesisG-POEMNCT04434781
Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis
An observational study of Gastroparesis, run by Indiana University at 1 site in United States.
Trial summary
Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Gastroparesis
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Aug 2018to 15 Aug 2026
- Phase
- Observational
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: As long as patients fall under the inclusion criteria and do not fall under exclusions, every patient can be considered. Patient must be declared safe to undergo procedure on individual basis from an evaluation from head doctor on study.
Who may be able to join
- 18 years of age
- Referral for endoscopic treatment of Gastroparesis for symptom management
Who cannot join
- < 18 years of age
- Absence of gastroparesis based on scintigraphy studies
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Indiana University Hospital
Indianapolis, Indiana, 46202
Mohammad Al-Haddad, MD, 3179440980, moalhadd@iu.edu
About this study
Official title: Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis: A Database Repository
Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.
Read the detailed description
Gastroparesis is a disease of the stomach where there is significant delay in gastric emptying of contents to the intestines. This disease results in a multitude of symptoms including nausea, vomiting, weight loss, and malnutrition.
Current treatments for gastroparesis include dietary changes, oral medications (prokinetic agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and vomiting), gastric stimulators and rarely surgery.
G-POEM (Gastric Per-Oral Endoscopic Myotomy-creating a cut in the muscle that controls gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic procedure, is increasingly being performed to assist in the management of certain groups of patients with gastroparesis.
This data will be used for research purposes only to determine the clinical impact of endoscopic treatments on gastroparesis. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.
- Conditions
- Gastroparesis
- Keywords
- GPOEM, Gastric Per-Oral Endoscopic Myotomy, Myotomy, Gastroparesis, g-poem
- Medical subject headings
- Gastroparesis
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM
The Gastroparesis Cardinal Symptom Index (GCSI) is used for assessing severity of symptoms associated with gastroparesis. Patients are to score each of the 9 symptom criteria on 0 (None) to 5 (Very Severe) Likert Scale. The higher the score the more symptomatic from gastroparesis the patient is.
Nausea or Vomiting (score 0-5 for each of the following 3 criteria)
- Nausea
- Retching
- Vomiting Postprandial fullness or early satiety (score 0-5 for each of the following 4 criteria)
- Stomach Fullness
- Not able to finish a normal-sized meal
- Feeling excessively full after meals
- Loss of appetite Bloating (score 0-5 for each of the following 2 criteria)
- Bloating
- Stomach visibly larger
Measured: 60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months
Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM
Change in PAGI-Sym score: The PAGI-SYM is composed of 20 items and 6 subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe)
Measured: 60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months
Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM
Change in health belief questionnaire (SF-36) score: Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher scores indicate better health
Measured: baseline and assess change at 1,3,6,12,24,36,48 & 60 months
Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM
we will track change in GES at 6 months and 24 months post G-POEM and compare to baseline. Normal GES should have under 5% at 4 hours
Measured: baseline; and assess change at 6, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2020
- Study start7 Aug 2018
- Primary completion15 Aug 2026 (estimated)
- Study completion15 Aug 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GastroparesisStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammad Al-Haddad, Indiana University
- Investigators
- Mohammad Al-Haddad, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04434781
- Sponsor's protocol ID
- 1708840627
- Acronym
- G-POEM
- Status last verified
- Feb 2026
- First submitted
- 10 Oct 2018
- Last updated
- 18 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Ichkhanian Y, Salame M, Wo JM, Nowak TV, Stainko S, Saito A, Siwiec RM, Kais A, Hwang JH, Li AA, Yang J, Broucek JR, Esfandyari T, Joseph S, Ujiki MB, Williams AE, Moremen J, Gouda Z, Schlachterman A, Hugova K, Martinek J, Geng CX, Podboy A, Wang AY, Lajin M, Gregor L, Miller PM, Al Bunni H, DeWitt JM, Al-Haddad M. A New International Scheme for the Classification and Management of Clinical Outcomes Post-gastric Peroral Endoscopic Myotomy. Clin Gastroenterol Hepatol. 2025 Dec;23(13):2477-2487.e1. doi: 10.1016/j.cgh.2025.03.022. Epub 2025 May 14.
PubMed 40378985Salame M, Ichkhanian Y, Hadaki N, Wo JM, Stainko SA, Saito A, Siwiec RM, Nowak TV, Li A, Hwang JH, Yang J, Broucek J, Esfandyari T, Joseph S, Ujiki M, Williams AE, Moremen JR, Gouda Z, Schlachterman A, Hugova K, Martinek J, Geng CX, Podboy A, Wang AY, Lajin M, Miller P, Gregor L, Albunni H, Dewitt JM, Al-Haddad MA. Safety of same-day discharge after gastric peroral endoscopic myotomy in patients with refractory gastroparesis: an international multicenter study. Gastrointest Endosc. 2025 Oct;102(4):595-599.e1. doi: 10.1016/j.gie.2025.02.020. Epub 2025 Feb 19.
PubMed 39983999
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis: A Database Repository
- ClinicalTrials.gov ID
- NCT04434781
- Acronym / sponsor ID
- G-POEM / 1708840627
- Conditions
- Gastroparesis
- Keywords
- GPOEM, Gastric Per-Oral Endoscopic Myotomy, Myotomy, Gastroparesis, g-poem
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 7 Aug 2018 (actual)
- Primary completion
- 15 Aug 2026 (estimated)
- Study completion
- 15 Aug 2026 (estimated)
- First posted
- 17 Jun 2020 (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.
Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.
Detailed description
Gastroparesis is a disease of the stomach where there is significant delay in gastric emptying of contents to the intestines. This disease results in a multitude of symptoms including nausea, vomiting, weight loss, and malnutrition.
Current treatments for gastroparesis include dietary changes, oral medications (prokinetic agents to enhance gastric motility, acid reducers, anti-emetics to reduce nausea and vomiting), gastric stimulators and rarely surgery.
G-POEM (Gastric Per-Oral Endoscopic Myotomy-creating a cut in the muscle that controls gastric emptying), an incision-less (no cutting of the surface of the body) endoscopic procedure, is increasingly being performed to assist in the management of certain groups of patients with gastroparesis.
This data will be used for research purposes only to determine the clinical impact of endoscopic treatments on gastroparesis. The physicians will also be able to better understand the patient's condition and disease process that may lead to improved standard of care and improved patient management.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- As long as patients fall under the inclusion criteria and do not fall under exclusions, every patient can be considered. Patient must be declared safe to undergo procedure on individual basis from an evaluation from head doctor on study.
Key inclusion criteria (2 listed)
- 18 years of age
- Referral for endoscopic treatment of Gastroparesis for symptom management
Key exclusion criteria (2 listed)
- < 18 years of age
- Absence of gastroparesis based on scintigraphy studies
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM
Time frame: 60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months
The Gastroparesis Cardinal Symptom Index (GCSI) is used for assessing severity of symptoms associated with gastroparesis. Patients are to score each of the 9 symptom criteria on 0 (None) to 5 (Very Severe) Likert Scale. The higher the score the more symptomatic from gastroparesis the patient is. Nausea or Vomiting (score 0-5 for each of the following 3 criteria) * Nausea * Retching * Vomiting Postprandial fullness or early satiety (score 0-5 for each of the following 4 criteria) * Stomach Fullness * Not able to finish a normal-sized meal * Feeling excessively full after meals * Loss of appetite Bloating (score 0-5 for each of the following 2 criteria) * Bloating * Stomach visibly larger
Assessment of Change in Patient Assessment of gastrointestinal disorders-symptom severity index (PAGI-SYM) score from baseline to post G-POEM
Time frame: 60 months span: baseline and assess change at 1,3,6,12,24, 36,48 & 60 months
Change in PAGI-Sym score: The PAGI-SYM is composed of 20 items and 6 subscales: heartburn/regurgitation (7 items), nausea/vomiting (3 items), postprandial fullness/early satiety (4 items), bloating (2 items), upper abdominal pain (2 items), and lower abdominal pain (2 items). Subscale scores are calculated by averaging across items comprising the subscale; scores vary from 0 (none or absent) to 5 (very severe)
Assessment of Change in G-POEM SF-36 Health Survey score from baseline to post G-POEM
Time frame: baseline and assess change at 1,3,6,12,24,36,48 & 60 months
Change in health belief questionnaire (SF-36) score: Short Form (36) Health Survey is a 36-item, patient-reported survey of patient health. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability and the higher scores indicate better health
Assessment of change in Gastric Emptying Scan (GES) (solid phase, 4 hour study) from baseline to post G-POEM
Time frame: baseline; and assess change at 6, and 24 months
we will track change in GES at 6 months and 24 months post G-POEM and compare to baseline. Normal GES should have under 5% at 4 hours
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 18 Feb 2026.
- Derived from this study: PubMed 40378985Ichkhanian Y, Salame M, Wo JM, Nowak TV, Stainko S, Saito A, Siwiec RM, Kais A, Hwang JH, Li AA, Yang J, Broucek JR, Esfandyari T, Joseph S, Ujiki MB, Williams AE, Moremen J, Gouda Z, Schlachterman A, Hugova K, Martinek J, Geng CX, Podboy A, Wang AY, Lajin M, Gregor L, Miller PM, Al Bunni H, DeWitt JM, Al-Haddad M. A New International Scheme for the Classification and Management of Clinical Outcomes Post-gastric Peroral Endoscopic Myotomy. Clin Gastroenterol Hepatol. 2025 Dec;23(13):2477-2487.e1. doi: 10.1016/j.cgh.2025.03.022. Epub 2025 May 14.
- Derived from this study: PubMed 39983999Salame M, Ichkhanian Y, Hadaki N, Wo JM, Stainko SA, Saito A, Siwiec RM, Nowak TV, Li A, Hwang JH, Yang J, Broucek J, Esfandyari T, Joseph S, Ujiki M, Williams AE, Moremen JR, Gouda Z, Schlachterman A, Hugova K, Martinek J, Geng CX, Podboy A, Wang AY, Lajin M, Miller P, Gregor L, Albunni H, Dewitt JM, Al-Haddad MA. Safety of same-day discharge after gastric peroral endoscopic myotomy in patients with refractory gastroparesis: an international multicenter study. Gastrointest Endosc. 2025 Oct;102(4):595-599.e1. doi: 10.1016/j.gie.2025.02.020. Epub 2025 Feb 19.
Related trials for Gastroparesis
Recruiting
Gastric Focused Ultrasound Stimulation
Gastroparesis, Delayed Gastric Emptying
RecruitingObservational study
Rare Disease Patient Registry & Natural History Study - Coordination of Rare Diseases at Sanford
Rare Disorders, Undiagnosed Disorders
Enrolling by invitationObservational study
Body Surface Gastric Mapping to Evaluate Patients With Upper Gastrointestinal Symptoms and Controls
Motility Disorder, Gastroparesis
Not yet recruiting
Stomach-Partitioning Versus Conventional Gastrojejunostomy for Malignant Gastric Outlet Obstruction: A Multicenter Randomized Controlled Trial
Gastric Cancer, Gastric Outlet Obstruction
Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
Type 1 Diabetes, Gastroparesis Due to Diabetes Mellitus Type I
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.
Mohammad Al-Haddad, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroparesis, run by Indiana University 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 2 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 18 Feb 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?
Contact Jacque Peterman (317-944-0980, petermaj@iu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Change in Gastroparesis Cardinal Symptom Index (GCSI) from baseline to post G-POEM (time frame: 60 months span: baseline and assess change at 1 month, 3 month, 6 month, 12 month, 24 month, 36 month, 48 month & 60 months). The study lists 4 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 NCT04434781, which also lists 2 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 18 Feb 2026.