Tolerability of a Modified Health-Dx

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT06240650

Enrollment

Registered

2024-02-05

Start date

2023-07-26

Completion date

2024-07-02

Last updated

2024-08-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Healthy Volunteers

Brief summary

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

Interventions

DEVICEmodified 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.

DEVICEmodified 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026