Gastrointestinal Transit Monitoring Devices Comparison
Trial Summary
What is the purpose of this trial?
This trial aims to compare two different systems for measuring how long it takes for food to move through the stomach and intestines in patients with delayed stomach emptying and slow intestinal transit.
Do I need to stop my current medications for the trial?
Yes, you may need to stop certain medications. Specifically, you must stop medications that alter stomach acid levels (like proton pump inhibitors) 7 days before and during the study, and medications that affect gut movement (like GLP-1 agonists and anticholinergics) 72 hours before and during the study. Laxatives must also be stopped 72 hours before and during the study, with limited use allowed under certain conditions.
What data supports the effectiveness of the Atmo Motility Gas Capsule System and SmartPill Monitoring System treatment?
Research shows that wireless motility capsules, like the ones used in the Atmo Motility Gas Capsule System and SmartPill Monitoring System, can effectively measure how quickly food moves through the stomach and intestines. This helps doctors understand and treat conditions where the digestive system is too slow or too fast.12345
Is the wireless motility capsule safe for humans?
Research Team
Braden Kuo, MD
Principal Investigator
Massachusetts General Hospital
William Chey, MD
Principal Investigator
University of Michigan
Eligibility Criteria
Adults aged 22-80 with IBS-C, chronic idiopathic constipation, or delayed gastric emptying can join. They must have symptoms like nausea, bloating, or infrequent bowel movements and be likely to follow the study rules. Excluded are those with recent surgeries, certain diseases or drug use that affects digestion.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo testing with the Atmo Motility Gas Capsule System and SmartPill to measure gastric emptying time and colonic transit time
Follow-up
Participants are monitored for adverse events and device deficiencies
Treatment Details
Interventions
- Atmo Motility Gas Capsule System
- SmartPill Monitoring System
Find a Clinic Near You
Who Is Running the Clinical Trial?
Atmo Biosciences Pty Ltd
Lead Sponsor