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Completed

NCT Number: NCT06240650

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.

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Key information

Conditions

Healthy Volunteers

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

West Virginia University

Morgantown, West Virginia, 26506, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

modified Health- Dx™ (mHDx) study capsule

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

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.

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.

    Time frame: day 1

Sponsors and collaborators

Lead sponsor

Celero Systems, Inc.

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Feb 5, 2024
Registry last updated
Aug 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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