Trials US – Atmo Biosciences

Website Under Construction

PIVOTAL STUDY

Primary endpoints reached in dysmotility pivotal clinical study

In April 2024 Atmo reported it had successfully reached its primary endpoints in a pivotal clinical study to assess whole and regional gut transit time in subjects with suspected gastrointestinal motility disorders.

More than 200 subjects from 12 trial sites in the U.S. and Australia ingested the Atmo Gas Capsule and a predicate device, the Wireless Motility Capsule, to test the comparative ability of Atmo to assess the primary endpoints of gastric emptying time (emptying from the stomach) and colonic transit time (transit time in the large bowel) to assist with diagnosis of gastroparesis and slow transit constipation.

READ ARTICLE

PILOT TRIAL

Results show Atmo Gas Capsule can be used to assess whole gut transit times

A multicenter study, including 43 patients with suspected dysmotility ingested the Atmo capsule and SmartPill simultaneously and researchers compared the transit times of the two capsules through the different regions of the gastrointestinal tract.

SmartPill uses pH, temperature and pressure to identify when the pill moves through different gut regions, whereas the Atmo capsule uses a range of measures including hydrogen and carbon dioxide concentration, and temperature.

Results showed the two devices had similar transit times and diagnostic agreement, thereby validating the Atmo capsule relative to SmartPill for measurements of gastric emptying time and colonic transit time for patients with gastroparesis and chronic constipation.

The study follows a clinical trial demonstrating strong agreement between the Atmo Gas Capsule and SmartPill for measuring transit time in healthy subjects.The results showed that the Atmo Gas Capsule was readily ingested, well-tolerated and technically reliable.

READ ARTICLE