Recruiting

G-POEM

Sponsor:

Indiana University

Code:

NCT06493032

Conditions

Gastroparesis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Gastric Alimetry System

Study Details

Brief summary:

The purpose of this study is to investigate whether or not the investigators can utilize Body Surface Gastric Mapping to determine who would best benefit to receive G-POEM procedure and how Body Surface Gastric Mapping can be utilized with patients who have gastroparesis symptoms. the investigators may also be able to find more ways how Body Surface Gastric Mapping testing can benefit patients with gastroparesis and/or G-POEM procedure.

Conditions

Gastroparesis

Study ID

NCT06493032

Start date

Nov 7, 2024

Status verified date

Sep, 2026

Completion date

Jun 1, 2028

Anticipated

Primary completion date

Jun 1, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • • Patients clinically eligible for G-Poem at our center.

Exclusion Criteria:

  • • Pregnant or breast-feeding

  • Patients with gastroparesis due to spinal cord injuries due to difficulties in conducting the BSGM. Of note, we rarely see gastroparesis in this context.
  • Inability to perform BSGM: history of severe skin allergies or sensitivity to cosmetics or lotions; chronically damaged or vulnerable epigastric skin (fragile skin, wounds, inflammation); patients unable to remain in a relaxed reclined position for the test duration.
  • Patients with abdominal drains or tubes

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Body Surface Gastric Mapping

Interventions

Gastric Alimetry System

medical device that uses a large sheet of electrodes to assess gastric motility

Primary outcome measure

  • Body Surface Gastric Mapping Rhythm IndexTM (GA-RI) [ Time Frame: Baseline, 3 months,6 months, up to 5 hours. ]
  • Principal Gastric Frequency [ Time Frame: Baseline, 3 months,6 months, up to 5 hours. ]
  • BMI-Adjusted Amplitude (μV) [ Time Frame: Baseline, 3 months,6 months, up to 5 hours. ]
  • Fed: Fasted Amplitude Ratio (ff-AR) [ Time Frame: Baseline, 3 months,6 months, up to 5 hours. ]
  • SF-36 [ Time Frame: Baseline, 3 months,6 months, up to 5 hours. ]

Central Contacts and Locations

Central contacts

Jacqueline Peterman

317-278-9242petermaj@iu.edu

Marita Salame, MD

masalame@iu.edu

Locations

Indiana University Health University Hospital

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Jacque Peterman

317-278-9242petermaj@iu.edu

Lainna Cohen

317-278-0621larcohen@iu.edu

More Information

Sponsor

Indiana University

Last update posted

Sep 8, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-12. This information was provided to ClinicalTrials.gov by Indiana University on 2026-09-08. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.