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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05183529
Other study ID # CIP-002
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date December 14, 2021
Est. completion date October 2024

Study information

Verified date February 2024
Source Celero Systems, Inc.
Contact Shannon M Schuetz
Phone 2169068416
Email sschuetz@celerosystems.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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 to performing an exploratory comparative analysis of data collected by the VM Pill and data collected from clinical monitoring sensors as part of polysomnography.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility Inclusion Criteria: - Healthy individuals ages 18 - 65 inclusive who are indicated for a polysomnography study. Exclusion Criteria: - 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Vitals Monitoring Pill System
The Celero Vitals Monitoring Pill (VM Pill) uses 3 axis accelerometry to measure physiological signals from within the GI tract.

Locations

Country Name City State
United States West Virginia University Morgantown West Virginia

Sponsors (1)

Lead Sponsor Collaborator
Celero Systems, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evaluate the ability of the VM Pill to monitor respiration from within the GI tract Mean absolute error between respiratory rate measured by the VM Pill and respiratory rate measured by PSG monitoring equipment during periods of normal breathing while the patient is sleeping or at rest. During polysomnography
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