Tolerability of a Modified Health-Dx
Randomized Controlled Study to Evaluate Tolerability of a Modified Health-Dx
1 other identifier
interventional
10
1 country
1
Brief Summary
Single Blind, Randomized Control Study is designed to evaluate the tolerability of the Celero Systems' modified Health-Dx™ (mHDx) capsule.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable healthy-volunteers
Started Jul 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2023
CompletedFirst Submitted
Initial submission to the registry
December 28, 2023
CompletedFirst Posted
Study publicly available on registry
February 5, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 2, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
July 2, 2024
CompletedAugust 9, 2024
August 1, 2024
11 months
December 28, 2023
August 7, 2024
Conditions
Outcome Measures
Primary Outcomes (1)
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
Study Arms (2)
modified Health- Dx™ (mHDx) study capsule
EXPERIMENTALmodified Health- Dx™ (mHDx) control capsule
OTHERInterventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
West Virginia University
Morgantown, West Virginia, 26506, United States
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 28, 2023
First Posted
February 5, 2024
Study Start
July 26, 2023
Primary Completion
July 2, 2024
Study Completion
July 2, 2024
Last Updated
August 9, 2024
Record last verified: 2024-08
Data Sharing
- IPD Sharing
- Will not share