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

NAActive, not recruitingINTERVENTIONAL
Enrollment

209

Participants

Timeline

Start Date

June 5, 2023

Primary Completion Date

December 15, 2023

Study Completion Date

April 30, 2024

Conditions
GastroparesisSlow Transit ConstipationIBS
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."

Trial Locations (2)

48109

University of Michigan, Ann Arbor

02114

Massachusetts General Hospital, Boston

Sponsors
All Listed Sponsors
lead

Atmo Biosciences Pty Ltd

INDUSTRY

NCT05718505 - Comparison of the Atmo Motility Gas Capsule System to the Reference Standard | Biotech Hunter | Biotech Hunter