Myoelectric GutPrint-Crohn's Disease (Gutcheck-CD)
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| ClinicalTrials.gov Identifier: NCT03774485 |
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Recruitment Status :
Recruiting
First Posted : December 13, 2018
Last Update Posted : April 28, 2022
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| Condition or disease | Intervention/treatment |
|---|---|
| Crohn Disease | Device: G-Tech Gutcheck Myoelectric recording device |
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 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, 2023 |
| Estimated Study Completion Date : | June 30, 2023 |
| Group/Cohort | Intervention/treatment |
|---|---|
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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.
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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 |
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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.
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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 |
- 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
- 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.
- Number of unanticipated adverse device effects [ Time Frame: Up to 6 days ]Unanticipated adverse device effects
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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 |
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)
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.
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
| Contact: Sidhartha Sinha, MD | 650-497-6216 | sidsinha@stanford.edu | |
| Contact: Steve Axelrod, PhD | 650-269-1479 | steve.axelrod@gtechhealth.com |
| United States, California | |
| Stanford University | Recruiting |
| Palo Alto, California, United States, 94305 | |
| Contact: Sidhartha Sinha, MD sidsinha@stanford.edu | |
| Contact: Akshar Patel, BA 4088575682 aksharp1@stanford.edu | |
| Principal Investigator: | Sidhartha Sinha, MD | Stanford University |
| Responsible Party: | Sidhartha Ranjit Sinha, Associate Professor, Stanford University |
| ClinicalTrials.gov Identifier: | NCT03774485 |
| Other Study ID Numbers: |
IRB48539 |
| First Posted: | December 13, 2018 Key Record Dates |
| Last Update Posted: | April 28, 2022 |
| Last Verified: | April 2022 |
| 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. |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |
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Crohn Disease Inflammatory Bowel Diseases Gastroenteritis |
Gastrointestinal Diseases Digestive System Diseases Intestinal Diseases |