Tolerability of a Modified Health-Dx

NCT ID: NCT06240650

Last Updated: 2024-08-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-07-26

Study Completion Date

2024-07-02

Brief Summary

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

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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modified Health- Dx™ (mHDx) study capsule

Group Type EXPERIMENTAL

modified Health- Dx™ (mHDx) study capsule

Intervention Type DEVICE

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

Group Type OTHER

modified Health- Dx™ (mHDx) control capsule

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celero Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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West Virginia University

Morgantown, West Virginia, United States

Site Status

Countries

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United States

Other Identifiers

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CEL-005

Identifier Type: -

Identifier Source: org_study_id

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