In August 2023 Atmo commenced a pivotal clinical study to assess the use of the Atmo Gas Capsule® to measure gastrointestinal transit time in patients with suspected motility disorders.
The study involves simultaneous ingestion of the Atmo Gas Capsule and predicate device SmartPill to demonstrate the ability of Atmo’s gas-sensing capsule to assess whole and regional gut transit. Clinicians evaluate regional gut transit to help diagnose motility disorders such as gastroparesis (delayed emptying from the stomach), and slow transit constipation (slow transit through the colon).
During the study, patients ingest both the Atmo capsule and SmartPill, then go about their lives while the capsules continuously record measures as they travel through the different regions of the gastrointestinal tract.
This pivotal study follows a series of pilot trials comparing transit measurements from the Atmo Capsule to SmartPill, including one trial in healthy subjects and one in patients with symptoms of gastrointestinal motility disorders. Both studies validated the Atmo capsule relative to the SmartPill for measuring transit time.
The results from the study will be used to submit a 510(k) application to the U.S. Food and Drug Administration (FDA) to obtain marketing clearance for the device in the U.S.
Institutions participating in the pivotal study include Houston Methodist, Hartford HealthCare and Cleveland Clinic.