An interventional study of Atmo Motility Gas Capsule System and SmartPill Monitoring System in Gastroparesis, Slow Transit Constipation and IBS, sponsored by Atmo Biosciences Pty Ltd. Active, not recruiting at 2 sites in United States. Open to participants aged 22 Years to 80 Years. Per ClinicalTrials.gov, last updated 2024-01-10.
Sponsored by Atmo Biosciences Pty Ltd · Not applicable, Interventional, and Other
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.
307 studies on the registry are indexed under Gastroparesis; 68 are open to participants now.
This study's enrollment of 209 is above the median of 44 across 202 interventional studies indexed under Gastroparesis.
Browse Gastroparesis studies →Atmo Biosciences Pty Ltd is the lead sponsor of 3 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Exclusion Criteria:
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.
Device: SmartPill Monitoring System
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.
Device: 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 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.
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.
GET as measured by the Atmo Motility System
Interpretation of gastric emptying time by central readers using the Atmo Motility System
Time frame: Day 1 to Day 10
GET as measured by the SmartPill System
Interpretation of gastric emptying time by central readers of the SmartPill System
Time frame: 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
Time frame: Day 1 to Day 10
CTT as measured by the SmartPill System
Interpretation of colonic transit time by central readers using the SmartPill System
Time frame: Day 1 to Day 10
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
Time frame: Day 1 to Day 10
Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by SmartPill
Classification of all gut transit times as either delayed or not as measured by SmartPill
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: Day 0 to Day 31
Plan to share: No
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This study is active, not recruiting, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Atmo Biosciences Pty Ltd