Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis
NCT ID: NCT04434781
Last Updated: 2025-01-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
75 participants
OBSERVATIONAL
2018-08-07
2026-08-15
Brief Summary
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Detailed Description
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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
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Study Design
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OTHER
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
* Referral for endoscopic treatment of Gastroparesis for symptom management
Exclusion Criteria
* Absence of gastroparesis based on scintigraphy studies
18 Years
ALL
Yes
Sponsors
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Indiana University
OTHER
Responsible Party
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Mohammad Al-Haddad
Associate Professor of Medicine, Associate Clinical Director
Principal Investigators
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Mohammad Al-Haddad, MD
Role: PRINCIPAL_INVESTIGATOR
Indiana University
Locations
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Indiana University Hospital
Indianapolis, Indiana, United States
Countries
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Central Contacts
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Facility Contacts
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References
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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 May 14:S1542-3565(25)00410-0. doi: 10.1016/j.cgh.2025.03.022. Online ahead of print.
Salame 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.
Other Identifiers
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1708840627
Identifier Type: -
Identifier Source: org_study_id
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