UnknownNot Applicable

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

United States209 participantsStarted 2023-06-05

Plain-language 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.

Who can participate

Age range

22 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

Exclusion criteria

. Participant or their legally authorized representative has the ability to provide informed consent and comply with the protocol.
. Recent abdominal and/or pelvic surgery (past 3 months)
. Acute diverticulitis, confirmed by CT scan in past 3 months, diverticular stricture, and other intestinal strictures
. Chronic daily use of nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen)
. Pregnant or breastfeeding
. Patients on long-acting glucagon-like peptide (GLP-1)
. Active implantable devices (e.g. gastric stimulator, pacemaker, defibrillator) \[continuous glucose monitors are permitted\]
. 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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

GET as measured by the Atmo Motility System

Timeframe: Day 1 to Day 10

GET as measured by the SmartPill System

Timeframe: Day 1 to Day 10

CTT as measured by the Atmo Motility System

Timeframe: Day 1 to Day 10

CTT as measured by the SmartPill System

Timeframe: Day 1 to Day 10

Trial details

NCT IDNCT05718505

SponsorAtmo Biosciences Pty Ltd

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-12-15

View on ClinicalTrials.gov More Gastroparesis trials

Who can participate

Age range

22 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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:

Exclusion criteria

. Participant or their legally authorized representative has the ability to provide informed consent and comply with the protocol.
. Recent abdominal and/or pelvic surgery (past 3 months)
. Acute diverticulitis, confirmed by CT scan in past 3 months, diverticular stricture, and other intestinal strictures
. Chronic daily use of nonsteroidal anti-inflammatory drugs (e.g. ibuprofen, naproxen)
. Pregnant or breastfeeding
. Patients on long-acting glucagon-like peptide (GLP-1)
. Active implantable devices (e.g. gastric stimulator, pacemaker, defibrillator) \[continuous glucose monitors are permitted\]
. 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