Tolerability of a Modified Health-Dx

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

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

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Device: modified Health- Dx™ (mHDx) study capsule; Device: modified Health- Dx™ (mHDx) control capsule

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • West Virginia
    • Morgantown, West Virginia, United States, 26506
      • West Virginia University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: modified Health- Dx™ (mHDx) study capsule	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.
Other: modified Health- Dx™ (mHDx) control capsule	Device: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Collaborators and Investigators

• Sponsor: Celero Systems, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): July 26, 2023
• Primary Completion (Actual): July 2, 2024
• Study Completion (Actual): July 2, 2024

Study Registration Dates

• First Submitted: December 28, 2023
• First Submitted That Met QC Criteria: January 26, 2024
• First Posted (Actual): February 5, 2024

Study Record Updates

• Last Update Posted (Actual): August 9, 2024
• Last Update Submitted That Met QC Criteria: August 7, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: CEL-005

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes