Status:
COMPLETED
Myoelectric GutPrint-Crohn's Disease
Lead Sponsor:
Stanford University
Collaborating Sponsors:
The Leona M. and Harry B. Helmsley Charitable Trust
G-Tech Corporation
Conditions:
Crohn Disease
Eligibility:
All Genders
18-75 years
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 ...
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...
Eligibility Criteria
Inclusion
- Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.
Exclusion
- 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.
Key Trial Info
Start Date :
January 1 2019
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
June 15 2023
Estimated Enrollment :
136 Patients enrolled
Trial Details
Trial ID
NCT03774485
Start Date
January 1 2019
End Date
June 15 2023
Last Update
October 6 2023
Active Locations (1)
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1
Stanford University
Palo Alto, California, United States, 94305