Tolerability of a Modified Health-Dx

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Description

Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.

Targeted Conditions

Study Overview

Start Date
July 26, 2023
Completion Date
July 31, 2024
Enrollment
10
Date Posted
February 5, 2024
Accepts Healthy Volunteers?
Yes
Gender
All

Locations

Full Address
West Virginia University
Morgantown, West Virginia 26506, United States

Eligibility

Minimum Age (years)
18
Maximum Age (years)
75
Eligibility Criteria
Inclusion Criteria:

Healthy individuals ages 18 - 75 inclusive
Subject is a suitable candidate for study participation in the opinion of the Investigator
Subject has been informed of the nature of the study and has provided written informed consent as approved by the WVU IRB

Exclusion Criteria:

Subjects with a history of any condition that may impact the GI tract
Subjects who are unable to swallow a 000 sized capsule
Subjects with an implanted medical device that has wireless data communication capability
Subjects planning to undergo an MRI within 30 days after the study
Subjects with a BMI > 40 (severe obesity)
Subjects who are pregnant or are nursing
Any subject deemed to be at risk of a gastrointestinal complication as evaluated by a gastroenterologist prior to study enrollment

Study Contact Info

Study Contact Name
Shannon Schuetz
Study Contact Email
Study Contact Phone

Contact Listings Owner Form

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Other Details

FDA Regulated Drug?
No
FDA Regulated Device?
Yes
NCTid (if applicable)
NCT06240650