The Use of Body Surface Gastric Mapping in Assessing the Clinical Success of G-POEM

NCT06493032 | Recruiting FDA Device

• 1 other identifier: 20972
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• Body Surface Gastric Mapping Rhythm IndexTM (GA-RI)

  A measure of the concentration of amplitude in the gastric frequency band over time (between 0 and 1), which characterizes the rhythmic stability of the recorded gastric activity; also adjusted for BMI.

  Baseline, 3 months,6 months, up to 5 hours.

• Principal Gastric Frequency

  Characterizes the frequency associated with stable, persistent gastric activity as defined by GA-R

  Baseline, 3 months,6 months, up to 5 hours.

• BMI-Adjusted Amplitude (μV)

  characterizes the strength of the recorded gastric activity as an average of the whole-test amplitude, adjusted for BMI

  Baseline, 3 months,6 months, up to 5 hours.

• Fed: Fasted Amplitude Ratio (ff-AR)

  characterizes the responsiveness to a meal stimulus, which is calculated as a ratio of the maximal 1-h average postprandial amplitude to the amplitude in the preprandial period.

  Baseline, 3 months,6 months, up to 5 hours.

• SF-36

  a set of generic, coherent, and easily administered quality-of-life measures

  Baseline, 3 months,6 months, up to 5 hours.

Secondary Outcomes (1)

• Body surface gastric mapping (BSMG)

  Baseline, 3 months,6 months, up to 5 hours.

Study Arms (1)

Body Surface Gastric Mapping

EXPERIMENTAL

Device: Gastric Alimetry System

Interventions

Gastric Alimetry System DEVICE

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

Also known as: Body Surface Gastric Mapping, BSMG, Electrogastrography System

Body Surface Gastric Mapping

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Indiana University Health University Hospital

Indianapolis, Indiana, 46202, United States

RECRUITING

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 Unversity/Indiana University Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jacqueline Peterman

CONTACT

317-278-9242; petermaj@iu.edu

Marita Salame, MD

CONTACT

masalame@iu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: enrolling 20 participants who are being referred for G-POEM procedure into this study for a baseline alimetry and then again at 3-6 months.

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: July 9, 2024
• Study Start: November 7, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)