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The study objective is to demonstrate the equivalence of the Atmo Motility Gas Capsule System with the predicate SmartPill in measuring gastric emptying time and colonic transit time through examination of device agreement.
The clinical protocol for the study is designed to compare the performance of the Atmo Motility Gas Capsule System to the predicate device, the SmartPill GI Monitoring System, in patients with chronic GI symptoms suggestive of GI motility disorders (specifically gastroparesis and slow transit constipation), in order to demonstrate substantial equivalence. This study will involve the recruitment of symptomatic participants from a population that is representative of that for which the device is intended.
The primary objective of this study is the assessment of the agreement of Atmo Motility and SmartPill Systems' results with regards to both GET and CTT. The SmartPill is the accepted gold standard test for GI motility transit time analysis. Device agreement will be primarily examined through Bland-Altman analyses for GET and CTT measurements from the Atmo Motility and SmartPill Systems.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SmartPill Monitoring System | Active Comparator | 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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| Atmo Motility Gas Capsule System | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Atmo Motility Gas Capsule System | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| GET as measured by the Atmo Motility System | Interpretation of gastric emptying time by central readers using the Atmo Motility System | Day 1 to Day 10 |
| GET as measured by the SmartPill System | Interpretation of gastric emptying time by central readers of the SmartPill System | Day 1 to Day 10 |
| CTT as measured by the Atmo Motility System | Interpretation of colonic transit time by central readers using the Atmo Motility System | Day 1 to Day 10 |
| CTT as measured by the SmartPill System | Interpretation of colonic transit time by central readers using the SmartPill System | Day 1 to Day 10 |
| Measure | Description | Time Frame |
|---|---|---|
| Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by Atmo Motility System | Classification of all gut transit times as either delayed or not as measured by the Atmo System | Day 1 to Day 10 |
| Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by SmartPill |
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Inclusion Criteria:
Adults (M/F/other) between the ages of 22-80 years of age
High probability of compliance and completion of study.
Fulfilling one or more of the following criteria:
A. Received a delayed gastric emptying result from a gastric emptying study (gastric scintigraphy [GES] or gastric emptying breath test [GEBT] or SmartPill) in the last two years AND/OR presenting with 2 or more of the following symptoms or signs: i. Nausea, vomiting, or retching (dry heaves) ii. Postprandial fullness or early satiety iii. Bloating or visible abdominal distention iv. Postprandial discomfort or pain AND/OR; B. Suffering from symptoms of chronic idiopathic constipation based on ROME IV criteria (exclusion of constipation caused by structural abnormalities), participant should have at least 1 bowel motion per week (either assisted or unassisted by medication) AND/OR; C. Suffering from symptoms of IBS-C based on ROME IV criteria
Participant or their legally authorized representative has the ability to provide informed consent and comply with the protocol.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Braden Kuo, MD | Massachusetts General Hospital | Principal Investigator |
| William Chey, MD | University of Michigan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Massachusetts General Hospital | Boston | Massachusetts | 02114 | United States | ||
| University of Michigan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39889900 | Derived | Kuo B, Lee AA, Abell T, Attaluri A, Cline M, Hasler W, Ho V, Lembo AJ, Masoud A, McCallum R, Moshiree B, Quigley EMM, Rao SSC, Stocker A, Sanchez M, Sarosiek I, Surjanhata B, Zhou J, Chey WD. The Assessment of Gastrointestinal Transit by the Atmo Capsule: A Comparison With the SmartPill Capsule. Clin Gastroenterol Hepatol. 2025 Aug;23(9):1633-1641.e8. doi: 10.1016/j.cgh.2024.12.013. Epub 2025 Jan 30. |
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| ID | Term |
|---|---|
| D018589 | Gastroparesis |
| ID | Term |
|---|---|
| D013272 | Stomach Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010243 | Paralysis |
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| ID | Term |
|---|---|
| D016503 | Drug Delivery Systems |
| ID | Term |
|---|---|
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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All participants will ingest the investigational and predicate device in a tandem ingestion. The order of device ingestion will be randomized, controlled centrally via an Electronic Data Capture system.
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|
| SmartPill Monitoring System | Device | 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. |
|
Classification of all gut transit times as either delayed or not as measured by SmartPill |
| Day 1 to Day 10 |
| Classification as rapid or not for all transit times: GET, SBTT, OCTT, SLBTT, CTT and WGTT as determined by the Atmo Motility System | Classification of all gut transit times as either rapid or not as measured by Atmo | Day 1 to Day 10 |
| Classification as rapid or not for all transit times: GET, SBTT, OCTT, SLBTT, CTT and WGTT as determined by SmartPill | Classification of all gut transit times as either rapid or not as measured by SmartPill | Day 1 to Day 10 |
| Continuous transit time measures for SBTT, OCTT, SLBTT and WGTT for SmartPill and Atmo Motility Systems | Measurement of gut transit times as as measured by the SmartPill and Atmo Systems, expressed in hours:minutes | Day 1 to Day 10 |
| Qualitative description of per participant hydrogen and carbon dioxide gas profiles as determined by the Atmo Motility System | Description of gas production profiles as measured by the Atmo Motility System | Day 1 to Day 10 |
| Adverse Events (AEs), Serious Adverse Events (SAEs), Adverse Device Effects (ADEs), Serious Adverse Device Effects (SADEs), Unanticipated Serious Adverse Device Effects (USADEs) and device deficiencies | Description, number and outcomes of all adverse events, serious adverse events and others, summarized by recruitment site | Day 0 to Day 31 |
| Ann Arbor |
| Michigan |
| 48109 |
| United States |
| D009461 |
| Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |