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 range22 Years – 80 Years

SexALL

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

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 range22 Years – 80 Years

SexALL

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