Tolerability of a Modified Health-Dx
Not Applicable
Completed
- Conditions
- Healthy Volunteers
- Registration Number
- NCT06240650
- Lead Sponsor
- Celero Systems, Inc.
- Brief Summary
Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 10
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 & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The difference, if any, in tolerability between the Study and Control as reported via the study questionnaire. mHDx as reported by the subjects. day 1
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
West Virginia University
🇺🇸Morgantown, West Virginia, United States
West Virginia University🇺🇸Morgantown, West Virginia, United States