Myoelectric GutPrint-Crohn's Disease

Completed

• Conditions: Crohn Disease
• Interventions: Device: G-Tech Gutcheck Myoelectric recording device

• Registration Number: NCT03774485
• Lead Sponsor: Stanford University

Brief Summary

A feasibility study for assessing and recording myoelectric activity in patients for early detection of flare in patients with Crohn's disease and differentiating the myoelectric signals from Crohn's disease patients in remission state and healthy controls.

Detailed Description

Crohn's disease (CD) patients can have a chronic, relapsing course with frequent flares despite aggressive therapy. Flares are often difficult to predict. The goal of disease monitoring is to identify patients at risk for flare in order to treat earlier, with the hope of maintaining remission and avoiding irreversible bowel damage such as fistulas and strictures that may lead to surgery. Although endoscopic visualization of the mucosa allows in some cases ability to predict flare and determine deep remission, this procedure is invasive and requires anesthesia and a bowel preparation, and is not without risk. Abdominal pain, cramps and diarrhea are particularly common symptoms of CD, which are associated with alteration of gastrointestinal (GI) motility. Thus better understanding of GI motility patterns in CD flare and remission states may be helpful for prediction of flare for guiding appropriate therapy.

The goal of this study is to determine whether the motility patterns measured by the G-Tech non-invasive, wireless patch system can provide useful insight for routine CD care. Three G-Tech patches will be placed on the patients' abdomen and they will be given an iPod Touch to carry with them for the next 3-6 days. Data from the patches is processed offline to obtain motility patterns of the stomach, small intestine and colon. These patterns represent a rich trove of data that can be studied in multiple ways to provide comparisons and insight. Some examples are the overall strength of motor activity in each of the organs, the duration and rhythmicity, the correlation with meals, pain events and bowel movements, day to day variations and their correlation with symptoms, and diurnal effects.

Study Timeline

• Study First Submitted: 2018-11-29
• Study First Submitted QC: 2018-12-10
• Study First Posted: 2018-12-13
• Study Start: 2019-01-01
• Primary Completion: 2023-03-31
• Study Completion: 2023-06-15
• Status Verified: 2023-10
• Last Update Submitted: 2023-10-03
• Last Update Posted: 2023-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

Inclusion Criteria

• Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.

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Exclusion Criteria

• Patients or subjects under the age of 18, pregnant, and those unable to give consent or follow direction.
• Healthy subjects with gastrointestinal symptoms or history of gastrointestinal surgeries.
• Patients with severe Crohn's disease due to complexity of disease, complication, and potential needs for surgery.
• Patients with bowel surgeries due to potential impact on the G-Tech results. For similar reasons we will exclude patients on new medications (e.g. within 3 months of enrollment) known to alter GI motility but we will not exclude patients on stable doses or chronic GI motility agents as this mimics "real world" in which the G-Tech patch will be used and we can learn the stability of the motility recordings over time in stable patients.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy controls	G-Tech Gutcheck Myoelectric recording device	Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in healthy controls. The investigator does not change the routine medical care of study participants.
Crohn's disease (flare state)	G-Tech Gutcheck Myoelectric recording device	Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (flare state). The investigator does not change the routine medical care of study participants.
Crohn's disease (remission state)	G-Tech Gutcheck Myoelectric recording device	Record gastrointestinal motility by G-Tech Gutcheck Myoelectric recording device in subjects with Crohn's disease (remission state). The investigator does not change the routine medical care of study participants.

Primary Outcome Measures

Name	Time	Method
Myoelectric activity pattern (physiological parameters)	change from baseline at 1 month, 3 months and 6 months after recruitment	Myoelectric activity pattern in Crohn's disease patients versus healthy controls

Secondary Outcome Measures

Name	Time	Method
Number of unanticipated adverse device effects	Up to 6 days	Unanticipated adverse device effects
Number of anticipated Adverse Events	Up to 6 days	Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.

Trial Locations

Locations (1)

Stanford University; 🇺🇸 Palo Alto, California, United States