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Myoelectric GutPrint-Crohn's Disease (Gutcheck-CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03774485
Recruitment Status : Recruiting
First Posted : December 13, 2018
Last Update Posted : November 1, 2019
Sponsor:
Collaborators:
The Leona M. and Harry B. Helmsley Charitable Trust
G-Tech Corporation
Information provided by (Responsible Party):
Aida Habtezion, 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.

Condition or disease Intervention/treatment
Crohn Disease Device: G-Tech Gutcheck Myoelectric recording device

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 three 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.

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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Longitudinal Study of Myoelectric GutPrint of Healthy Controls and Crohn's Disease Patients During Flare and Remission
Actual Study Start Date : January 1, 2019
Estimated Primary Completion Date : June 30, 2020
Estimated Study Completion Date : June 30, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort Intervention/treatment
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.
Device: G-Tech Gutcheck Myoelectric recording device
Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
Other Name: Gastro-intestinal electrical recording

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.
Device: G-Tech Gutcheck Myoelectric recording device
Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
Other Name: Gastro-intestinal electrical recording

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.
Device: G-Tech Gutcheck Myoelectric recording device
Three G-Tech patches are placed on the abdomen of the patient to record myoelectric activity.
Other Name: Gastro-intestinal electrical recording




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Healthy subjects without gastrointestinal symptoms or history of gastrointestinal surgeries.

Patients with Crohn's disease in remission state or flare state (exclude severe Crohn's disease due to complexity of disease, complication, and potential needs for surgery; on new medications 【e.g. within 3 months of enrollment】 known to alter GI motility or bowel surgeries due to potential impact on the G-Tech results)

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03774485


Contacts
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Contact: Aida Habtezion, MD (650) 736-5555 aida.habtezion@stanford.edu
Contact: Steve Axelrod, PhD 650-269-1479 steve.axelrod@gtechhealth.com

Locations
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United States, California
Stanford University Recruiting
Palo Alto, California, United States, 94305
Contact: AIDA HABTEZION, MD       aidah@stanford.edu   
Contact: Akshar Patel, BA    4088575682    aksharp1@stanford.edu   
Sponsors and Collaborators
Stanford University
The Leona M. and Harry B. Helmsley Charitable Trust
G-Tech Corporation
Investigators
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Principal Investigator: Aida Habtezion, MD Stanford University

Publications:

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Responsible Party: Aida Habtezion, Associate professor, Stanford University
ClinicalTrials.gov Identifier: NCT03774485    
Other Study ID Numbers: IRB48539
First Posted: December 13, 2018    Key Record Dates
Last Update Posted: November 1, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: We will share the data through publication of results. Individual participant data was not promised to be shared.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases