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COMPLETED

NCT05718505

Comparison of the Atmo Motility Gas Capsule System to the Reference Standard

Sponsor: Atmo Biosciences Pty Ltd

View on ClinicalTrials.gov

Summary

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.

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

Key Details

Gender

All

Age Range

22 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

209

Start Date

2023-06-05

Completion Date

2024-05-17

Last Updated

2026-10-28

Healthy Volunteers

Conditions

Gastroparesis Slow Transit Constipation IBS

Interventions

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.

DEVICE

SmartPill Monitoring System

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.

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

Locations (2)

Massachusetts General Hospital

Boston, Massachusetts, United States

University of Michigan

Ann Arbor, Michigan, United States