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

NCT ID: NCT05183529

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

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-12-14

Study Completion Date

2023-10-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sleep

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Patients undergoing polysomnography

Group Type EXPERIMENTAL

Vitals Monitoring Pill System

Intervention Type DEVICE

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

Interventions

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Vitals Monitoring Pill System

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

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celero Systems, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Justin Kupec, MD

Role: PRINCIPAL_INVESTIGATOR

West Virginia University

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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CIP-002

Identifier Type: -

Identifier Source: org_study_id

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