NCT05183529

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 14, 2021

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

December 21, 2021

Completed
20 days until next milestone

First Posted

Study publicly available on registry

January 10, 2022

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2023

Completed
Last Updated

August 9, 2024

Status Verified

August 1, 2024

Enrollment Period

1.8 years

First QC Date

December 21, 2021

Last Update Submit

August 7, 2024

Conditions

Sleep

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Patients undergoing polysomnography

EXPERIMENTAL
Device: Vitals Monitoring Pill System

Interventions

Vitals Monitoring Pill SystemDEVICE

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

Patients undergoing polysomnography

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Interventions

Drug Delivery Systems

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Justin Kupec, MD

    West Virginia University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 21, 2021

First Posted

January 10, 2022

Study Start

December 14, 2021

Primary Completion

September 30, 2023

Study Completion

October 31, 2023

Last Updated

August 9, 2024

Record last verified: 2024-08

Locations

US(1)