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Completed

NCT Number: NCT03774485

Myoelectric GutPrint-Crohn's Disease

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Stanford University

Palo Alto, California, 94305, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

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.

Treatment and study plan

G-Tech Gutcheck Myoelectric recording device

Device

Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.

Other names: Gastro-intestinal electrical recording

Primary outcomes

  1. Myoelectric activity pattern (physiological parameters)

    Time frame: 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 outcomes

  1. Number of anticipated Adverse Events

    Time frame: Up to 6 days

    Device related anticipated adverse events; such as, skin irritation due to adhesive from the skin patch.

  2. Number of unanticipated adverse device effects

    Time frame: Up to 6 days

    Unanticipated adverse device effects

Sponsors and collaborators

Lead sponsor

Stanford University

Other

Collaborators

  • G-Tech Corporation
  • The Leona M. and Harry B. Helmsley Charitable Trust

Registry information

Official study title

Longitudinal Study of Myoelectric GutPrint of Healthy Controls and Crohn's Disease Patients During Flare and Remission

Acronym: Gutcheck-CD

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
Dec 13, 2018
Registry last updated
Oct 6, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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