Myoelectric GutPrint-Crohn's Disease

Trial ID or NCT#

NCT03774485

Status

not recruiting iconNOT RECRUITING

Purpose

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.

Official Title

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

Eligibility Criteria

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: Yes
Inclusion Criteria:
  1. - Patients with Crohn's disease and healthy subjects above the age of 18 who are able to give consent and follow direction.
Exclusion Criteria:
  1. - 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.
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Investigator(s)

Sidhartha Sinha
Sidhartha Sinha
Gastroenterologist, Inflammatory bowel disease specialist
Assistant Professor of Medicine (Gastroenterology and Hepatology)

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Contact

Sidhartha Sinha, MD

View on ClinicalTrials.gov