Status:

COMPLETED

Monitoring Vital Signs With a Wireless Ingestible Device in Subjects Undergoing Polysomnography

Lead Sponsor:

Celero Systems, Inc.

Conditions:

Sleep

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief Summary

This Minimal Risk study is designed to evaluate the ability of the Celero ingestible Vitals Monitoring Pill (i.e., VM Pill) to measure respiration from within the gastrointestinal tract, in addition t...

Eligibility Criteria

Inclusion

  • Healthy individuals ages 18 - 65 inclusive who are indicated for a polysomnography study.

Exclusion

  • Patients with a history of abdominal surgery and/or any condition that may impact the GI tract, including but not limited to:
  • Constipation
  • Esophageal stricture
  • Esophagitis
  • Gastritis
  • Gastric ulcers
  • Peptic ulcer
  • Gallstones
  • Celiac Disease
  • Crohn's Disease
  • Ulcerative Colitis
  • Irritable Bowel Syndrome
  • Diverticulitis
  • Colorectal cancer

Key Trial Info

Start Date :

December 14 2021

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

October 31 2023

Estimated Enrollment :

20 Patients enrolled

Trial Details

Trial ID

NCT05183529

Start Date

December 14 2021

End Date

October 31 2023

Last Update

August 9 2024

Active Locations (1)

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West Virginia University

Morgantown, West Virginia, United States, 26506