Recruiting

G-POEM

Sponsor:

Indiana University

Code:

NCT04434781

Conditions

Gastroparesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Study Details

Brief summary:

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

Conditions

Gastroparesis

Study ID

NCT04434781

Start date

Aug 7, 2018

Status verified date

Feb, 2026

Completion date

Aug 15, 2026

Anticipated

Primary completion date

Aug 15, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

75 participants

Anticipated

Interventions and Outcome Measures

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 ]
  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Jacque Peterman

317-944-0980petermaj@iu.edu

Mohammad Al-Haddad, MD

317-944-0980moalhadd@iu.edu

Locations

Indiana University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Mohammad Al-Haddad, MD

3179440980moalhadd@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Feb 18, 2026

Last verified

Feb, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-11. This information was provided to ClinicalTrials.gov by Indiana University on 2026-02-18. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.