Gastrointestinal Transit Monitoring Devices Comparison
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new device, the Atmo Motility Gas Capsule System, to determine if it performs as well as the already-approved SmartPill Monitoring System in tracking food movement through the digestive system. It focuses on conditions such as delayed stomach emptying, chronic constipation, or irritable bowel syndrome with constipation (IBS-C). Participants should have experienced issues like nausea, bloating, or constipation, or have had a previous test indicating slow stomach emptying. The goal is to find an effective way to measure digestive health and aid in diagnosing related conditions. As an unphased trial, this study allows participants to contribute to innovative research that could enhance diagnostic tools for digestive health.
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 prior data suggests that these gastrointestinal transit monitoring devices are safe?
Research has shown that the Atmo Motility Gas Capsule System is as safe and effective as the SmartPill GI Monitoring System. Both devices track food movement through the digestive system. The Atmo Capsule, a new tool, measures gases and temperature in the gut. Studies indicate it performs as well as the SmartPill, which the FDA has already approved for assessing food transit time. This suggests that the Atmo Capsule is safe and well-tolerated for use in people.12345
Why are researchers excited about this trial?
The Atmo Motility Gas Capsule System is unique because it goes beyond standard measures of transit times by also capturing detailed data on the fermentation and gas profiles within the gastrointestinal (GI) tract. Unlike the SmartPill Monitoring System, which measures pH, temperature, and pressure, the Atmo system offers insights into hydrogen and carbon dioxide concentrations, which can illuminate gut health in new ways. Researchers are excited about this device as it could provide a more comprehensive understanding of GI motility and conditions like gastroparesis and slow transit constipation, potentially leading to more accurate diagnoses and targeted treatments.
What evidence suggests that these gastrointestinal transit monitoring devices are effective?
This trial will compare the Atmo Motility Gas Capsule System with the SmartPill Monitoring System. Research has shown that the Atmo Motility Gas Capsule System effectively checks how quickly food moves through the gut, aiding in diagnosing digestive movement problems. This system measures various gases and conditions in the stomach to determine if the gut moves too fast or too slow. Early results suggest that the Atmo Capsule provides reliable data similar to the SmartPill, which is already approved. Although the Atmo Capsule is not yet FDA-approved, studies indicate it performs as well as current technology. Overall, the Atmo Capsule offers a new way to understand stomach and intestinal function.15678
Who Is on the Research Team?
Braden Kuo, MD
Principal Investigator
Massachusetts General Hospital
William Chey, MD
Principal Investigator
University of Michigan
Are You a Good Fit for This Trial?
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 for a Trial Participant
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
What Are the Treatments Tested in This Trial?
Interventions
- Atmo Motility Gas Capsule System
- SmartPill Monitoring System
Trial Overview
The trial is testing if the Atmo Gas Capsule is as good as the SmartPill at measuring how fast food moves through the stomach and intestines in people with digestive issues.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
The Atmo Motility Gas Capsule System (Atmo Biosciences) offers a novel method for measuring GET, SBTT, SLBTT, CTT and WGTT. This device measures temperature, relative humidity, hydrogen concentration and carbon dioxide concentration, along with indicators of fermentation activity, capsule tumble and antenna reflectance as it transit through the GI tract. It has the added benefit of recording information on the fermentation and gas profiles within the GI tract.
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.
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Who Is Running the Clinical Trial?
Atmo Biosciences Pty Ltd
Lead Sponsor
Citations
Comparison of the 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 ...
2.
atmobiosciences.com
atmobiosciences.com/media-release-positive-atmo-capsule-clinical-trial-results-published/Positive Atmo Capsule Clinical Trial Results Published
The gas-sensing capsule is able to provide useful data to determine if a person's gut motility is too fast or slow. This personalised ...
The Assessment of Gastrointestinal Transit by the Atmo ...
These results demonstrate that the Atmo Capsule is a valid method for evaluating gastrointestinal transit.
K250940 - Ian Macfarlane - accessdata.fda.gov
Performance data demonstrate that the Atmo Gas Capsule System is as safe and effective as the SmartPill GI Monitoring. System, version 2.0.
5.
researchgate.net
researchgate.net/publication/388542411_The_assessment_of_gastrointestinal_transit_by_the_Atmo_Capsule_A_comparison_with_the_SmartPill_CapsuleThe Assessment of Gastrointestinal Transit by the Atmo ...
Although it has not yet been FDA-approved, comparative study data show that the Atmo capsule correlates well with existing technology in ...
The Assessment of Gastrointestinal Transit by the Atmo ...
The Atmo Capsule is a novel WMC that measures gases (H2, CO2, O2) and temperature. We aimed to compare and evaluate the performance characteristics of the Atmo ...
Comparison of Gas-sensing Capsule With Wireless Motility ...
Gas-sensing capsule transit data were analyzed by independently two trained representatives from Atmo Biosciences, who were blinded to the WMC results. A third ...
Atmo Biosciences
The Atmo Gas Capsule is an ingestible gas-sensing capsule that measures gases directly at the source of production throughout the gastrointestinal tract.
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