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Comparison of the Atmo Motility Gas Capsule System to the Reference Standard

NCT05718505 · Status: ACTIVE_NOT_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 209

Last updated 2024-01-10

No results posted yet for this study

Summary

The study objective is to demonstrate the equivalence of the Atmo Motility Gas Capsule System with the predicate SmartPill in measuring gastric emptying time and colonic transit time through examination of device agreement.

Conditions

Interventions

DEVICE

Atmo Motility Gas Capsule System

The Atmo System measures whole gut and regional gut transit times. Measurements of GI tract transit times are used for evaluating motility disorders. Gastric emptying time (GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed GET is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation, to aid in differentiating slow and normal transit constipation. In the case where ileocecal junction transit cannot be determined the system will report combined Small and Large Bowel Transit Time (SLBTT). Transit times are derived from measures of temperature, relative humidity, hydrogen concentration, and carbon dioxide concentration, in conjunction with indicators of fermentation activity, capsule tumble, and antenna reflectance. Not for use in pediatric patients.

DEVICE

SmartPill Monitoring System

The SmartPill GI Monitoring System (Medtronic) offers a method for measuring gastric emptying time (GET), small bowel transit time (SBTT), colonic transit time (CTT), small bowel large bowel transit time (SLBTT) and whole gut transit time (WGTT) with a single test, which can be used as an aid for the diagnosis of both gastroparesis and slow transit constipation. The SmartPill System measures pH, temperature and pressure. It is approved for use in the measurement of GI transit times by the FDA.

Sponsors & Collaborators

  • Atmo Biosciences Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Braden Kuo, MD · Massachusetts General Hospital

  • William Chey, MD · University of Michigan

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-05
Primary Completion
2023-12-15
Completion
2024-04-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05718505 on ClinicalTrials.gov