Gastric Per-Oral Endoscopic Myotomy (G-POEM) for the Treatment of Gastroparesis

NCT04434781 | Recruiting

• 1 other identifier: 1708840627
• Study Type: observational
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

Gastric Per-Oral Endoscopic Myotomy (G-POEM) is a procedure for the Treatment of Gastroparesis.

Conditions

Gastroparesis

Keywords

GPOEM; Gastric Per-Oral Endoscopic Myotomy; Myotomy; Gastroparesis; g-poem

Outcome Measures

Primary Outcomes (4)

• 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

  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)

  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

  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

  baseline; and assess change at 6, and 24 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• years of age
• Referral for endoscopic treatment of Gastroparesis for symptom management

You may not qualify if:

• \< 18 years of age
• Absence of gastroparesis based on scintigraphy studies

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 40378985 DERIVED

• 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.

  PMID: 39983999 DERIVED

MeSH Terms

Conditions

Gastroparesis

Condition Hierarchy (Ancestors)

Stomach Diseases; Gastrointestinal Diseases; Digestive System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mohammad Al-Haddad, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacque Peterman

CONTACT

317-944-0980; petermaj@iu.edu

Mohammad Al-Haddad, MD

CONTACT

317-944-0980; moalhadd@iu.edu

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Medicine, Associate Clinical Director

Study Record Dates

• First Submitted: October 10, 2018
• First Posted: June 17, 2020
• Study Start: August 7, 2018
• Primary Completion (Estimated): August 15, 2026
• Study Completion (Estimated): August 15, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (1)