Gastroparesis Clinical Trial
Official title:
Comparison of the Atmo Motility Gas Capsule System to the Reference Standard (SmartPill) for Gastrointestinal Transit Time Measures in Patients With Functional Gastrointestinal Symptoms and Dysmotility
Verified date | January 2024 |
Source | Atmo Biosciences Pty Ltd |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 209 |
Est. completion date | April 2024 |
Est. primary completion date | December 15, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 22 Years to 80 Years |
Eligibility | Inclusion Criteria: 1. Adults (M/F/other) between the ages of 22-80 years of age 2. High probability of compliance and completion of study. 3. 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 4. Participant or their legally authorized representative has the ability to provide informed consent and comply with the protocol. Exclusion Criteria: 1. Recent abdominal and/or pelvic surgery (past 3 months) 2. Acute diverticulitis, confirmed by CT scan in past 3 months, diverticular stricture, and other intestinal strictures 3. Chronic daily use of nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen) 4. Pregnant or breastfeeding 5. Patients on long-acting glucagon-like peptide (GLP-1) 6. Active implantable devices (e.g. gastric stimulator, pacemaker, defibrillator) [continuous glucose monitors are permitted] 7. Evidence of metabolic disease within the last six months (overt hypothyroidism [high TSH, low FT4], uncontrolled diabetes [hemoglobin A1c >10%] within the past 6 months) not stabilized within the past 3 months via constant medication (dosage and type must be consistent) usage 8. History of gastric bezoar formation 9. Presence of fistulas or other mechanical GI obstruction 10. Radiation enteritis 11. History of fecal impaction 12. Suspicion of other organic GI disease 13. Suspicion of obscure GI bleeding 14. Unable to stop medications that may alter gastric pH (such as proton pump inhibitors) for 7 days prior to and during study 15. Unable to stop medications that may alter GI motility (GLP-1 agonists, anticholinergics, metformin, antispasmodic, prokinetics) for 72 hours prior to and during study. 16. Chronic daily use of cannabinoids (e.g., dronabinol, marijuana) 17. Unable to stop laxatives (docusate, lactulose, sorbitol, senna, bisacodyl), suppositories (glycerin), and enema 72 hours prior to and during the study. Limited use of rescue laxatives is permissible at the investigators discretion but must be tracked in the electronic case report form (eCRF). 18. May require an MRI scan during the duration of this study 19. BMI > 40kg/m2 20. Allergies to any of the ingredients used in the standardized meal |
Country | Name | City | State |
---|---|---|---|
United States | University of Michigan | Ann Arbor | Michigan |
United States | Massachusetts General Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Atmo Biosciences Pty Ltd |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | GET as measured by the SmartPill System | Interpretation of gastric emptying time by central readers of the SmartPill System | Day 1 to Day 10 | |
Primary | 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 | |
Primary | CTT as measured by the SmartPill System | Interpretation of colonic transit time by central readers using the SmartPill System | Day 1 to Day 10 | |
Secondary | 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 | |
Secondary | 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 | Day 1 to Day 10 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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