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Atmo SmartPill Comparison in Gastroparetic and Slow Transit Constipation Patients

NCT04977063 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 53

Last updated 2023-07-20

No results posted yet for this study

Summary

This study will compare gastrointestinal transit time measured by the SmartPill and the Atmo gas capsule in patients with gastrointestinal motility disorders. Both of these devices allow gastrointestinal transit time to be measured, however the SmartPill senses pH changes whereas the Atmo Capsule measures gas profiles. A total of 60 participants (30 diagnosed with gastroparesis, 30 with slow transit constipation) will attend Macarthur Clinical School at Western Sydney University after an overnight fast. Participants will consume a standardised meal before ingesting the SmartPill and Atmo Capsule. Each participant will carry a data receiver until passage of the capsules. Anatomical landmarks will be defined by pH changes (SmartPill) or oxygen profiles (Atmo Capsule). Statistical analysis will be performed via linear regression and degrees of agreement for measurements between the two devices. Primary end-points will be the agreement between gastric emptying, small intestinal and colonic transit times generated by the devices.

Conditions

Interventions

DEVICE

Atmo gas capsule

The Atmo Gas Capsule measures the capsules location and motility/transit times through gas sensing capabilities

DEVICE

SmartPill

The SmartPill measures the capsules location and motility/transit times through pH sensing

Sponsors & Collaborators

  • University of Western Sydney

    collaborator OTHER

  • Atmo Biosciences Pty Ltd

    lead INDUSTRY

Principal Investigators

  • Jerry Zhou, PhD BSc · School of Medicine, Western Sydney University

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-15
Primary Completion
2023-03-15
Completion
2023-03-15

Countries

  • Australia

Study Locations

More Related Trials

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 NCT04977063 on ClinicalTrials.gov