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Motility Monitoring System
Gastrointestinal Transit Monitoring Devices Comparison
N/A
Waitlist Available
Led By Braden Kuo, MD
Research Sponsored by Atmo Biosciences Pty Ltd
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Adults (M/F/other) between the ages of 22-80 years of age
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up day 1 to day 10
Awards & highlights
Study Summary
This trial aims to compare two medical devices to measure stomach and colon transit times in people. #medicaldevice
Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects aren't specified for this trial but may include discomfort from swallowing capsules or carrying monitoring equipment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am between 22 and 80 years old.
Select...
I have chronic constipation not caused by physical blockages and have at least one bowel movement weekly.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ day 1 to day 10
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~day 1 to day 10
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
CTT as measured by the Atmo Motility System
CTT as measured by the SmartPill System
GET as measured by the Atmo Motility System
+1 moreSecondary outcome measures
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
Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by Atmo Motility System
Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by SmartPill
+4 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Atmo Motility Gas Capsule SystemExperimental Treatment1 Intervention
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.
Group II: SmartPill Monitoring SystemActive Control1 Intervention
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 LtdLead Sponsor
3 Previous Clinical Trials
273 Total Patients Enrolled
1 Trials studying Gastroparesis
53 Patients Enrolled for Gastroparesis
Braden Kuo, MDPrincipal InvestigatorMassachusetts General Hospital
7 Previous Clinical Trials
707 Total Patients Enrolled
5 Trials studying Gastroparesis
609 Patients Enrolled for Gastroparesis
William Chey, MDPrincipal InvestigatorUniversity of Michigan
1 Previous Clinical Trials
60 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have had a blockage of stool in your intestines in the past.You are allergic to any of the ingredients in the standard meal.I have had a bezoar in my stomach before.I am taking long-acting GLP-1 medication.I cannot stop taking my stomach acid medication for a week.I might have another digestive system disease.My thyroid or diabetes condition has been stable for the last 3 months with consistent medication.I might have hidden bleeding in my digestive tract.I cannot stop taking my medications that affect stomach movement for 3 days before and during the study.I can't stop using my laxatives or enemas for 3 days before and during the study.You weigh more than what's considered healthy for your height.You have experienced delayed stomach emptying or have specific symptoms related to digestion and constipation.You have experienced delayed stomach emptying or have specific symptoms related to stomach discomfort, bloating, or constipation.You use cannabinoids like dronabinol or marijuana every day.I have a fistula or blockage in my digestive system.I have inflammation in my intestines from radiation.I have been diagnosed with constipation-predominant IBS.I have had abdominal or pelvic surgery in the last 3 months.You have an active implantable device like a pacemaker or defibrillator, except for a continuous glucose monitor.I have had a CT scan confirm acute diverticulitis in the last 3 months.I use pain relievers like ibuprofen or naproxen every day.I am between 22 and 80 years old.I have chronic constipation not caused by physical blockages and have at least one bowel movement weekly.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Research Study Groups:
This trial has the following groups:- Group 1: Atmo Motility Gas Capsule System
- Group 2: SmartPill Monitoring System
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does the age limit for participation in this clinical trial exceed 18 years of age?
"According to the study's guidelines, participants must be at least 22 years old and no more than 80."
Answered by AI
To whom is this research opportunity available?
"This medical trial is searching for 171 participants with gastroparesis and ages between 22-80."
Answered by AI
Is the research team presently looking for participants to join this trial?
"Affirmative. According to clinicaltrials.gov, the trial which commenced on April 1st 2023 and was last updated a month later is no longer recruiting patients. Nevertheless, 126 other trials are actively seeking participants at this time."
Answered by AI
What are the research objectives associated with this experiment?
"According to the study sponsor Atmo Biosciences Pty Ltd, they are assessing GET as measured by the SmartPill System over a 10-day period. Other secondary outcomes include classification of gut transit times (GET, SBTT, OCTT, SLBTT and CTT) for both Rapid or Not with either Atmo Motility Systems or Smartpill systems; plus continuous gut transit time measures for SBTT, OCTT, SBLBT and WGTT calculated in hours:minutes by both systems."
Answered by AI
Who else is applying?
What state do they live in?
Colorado
Washington
What site did they apply to?
University of Michigan
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
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