Myoelectric GutPrint-Crohn's Disease

NCT ID: NCT03774485

Last Updated: 2023-10-06

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 136 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2019-01-01
• Study Completion Date: 2023-06-15

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.

Conditions

Crohn Disease

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Healthy controls

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.

G-Tech Gutcheck Myoelectric recording device

Intervention Type: DEVICE

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

Crohn's disease (remission state)

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.

G-Tech Gutcheck Myoelectric recording device

Intervention Type: DEVICE

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

Crohn's disease (flare state)

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.

G-Tech Gutcheck Myoelectric recording device

Intervention Type: DEVICE

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

Interventions

G-Tech Gutcheck Myoelectric recording device

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

Intervention Type: DEVICE

Other Intervention Names

Gastro-intestinal electrical recording

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Leona M. and Harry B. Helmsley Charitable Trust

OTHER

Sponsor Role: collaborator

G-Tech Corporation

INDUSTRY

Sponsor Role: collaborator

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Sidhartha Ranjit Sinha

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sidhartha Sinha, MD

Role: PRINCIPAL_INVESTIGATOR

Stanford University

Locations

Stanford University

Palo Alto, California, United States

Countries

United States

References

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Other Identifiers

IRB48539

Identifier Type: -

Identifier Source: org_study_id