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NCT06240650 Clinical Trial

Tolerability of a Modified Health-Dx

Healthy Volunteers Clinical Trial

Official title:
Randomized Controlled Study to Evaluate Tolerability of a Modified Health-Dx

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT06240650
Other study ID # CEL-005
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 26, 2023
Est. completion date July 31, 2024

Study information
Verified date January 2024
Source Celero Systems, Inc.
Contact Shannon Schuetz
Phone 2169068416
Email sschuetz@celerosystems.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 10
Est. completion date July 31, 2024
Est. primary completion date July 31, 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 75 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Device:
• modified Health- Dx™ (mHDx) study capsule
The Study mHDx capsule has a mechanism that allows the mHDx to remain resident in the stomach for no more than six (6) hours. After this residency period, the Study mHDx will disassemble and pass safely through the subject's gastrointestinal system.
• modified Health- Dx™ (mHDx) control capsule
The Control mHDX capsule does not have a functional residency mechanism so it will disassemble once safely through the esophagus (within 10 minutes) and will then pass safely through the subject's gastrointestinal system.

Locations
Country Name City State
United States West Virginia University Morgantown West Virginia

Sponsors (1)
Lead Sponsor Collaborator
Celero Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
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