GastroparesisNCT05718505

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

A study testing Atmo Motility Gas Capsule System and SmartPill Monitoring System in people with Gastroparesis and Slow Transit Constipation, run by Atmo Biosciences Pty Ltd at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 22 to 80 years
Conditions the study is for: Gastroparesis, Slow Transit Constipation, IBS
What is being tested?: Atmo Motility Gas Capsule System and SmartPill Monitoring System
Type of treatment: Pill or oral medicine, Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 209 participants
Where: 2 sitesUnited States
Study dates: 5 Jun 2023to 17 May 2024
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 22 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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:
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
Participant or their legally authorized representative has the ability to provide informed consent and comply with the protocol.

Who cannot join

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]

Show all 20Show fewer

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
History of gastric bezoar formation
Presence of fistulas or other mechanical GI obstruction
Radiation enteritis
History of fecal impaction
Suspicion of other organic GI disease
Suspicion of obscure GI bleeding
Unable to stop medications that may alter gastric pH (such as proton pump inhibitors) for 7 days prior to and during study
Unable to stop medications that may alter GI motility (GLP-1 agonists, anticholinergics, metformin, antispasmodic, prokinetics) for 72 hours prior to and during study.
Chronic daily use of cannabinoids (e.g., dronabinol, marijuana)
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).
May require an MRI scan during the duration of this study
BMI > 40kg/m2
Allergies to any of the ingredients used in the standardized meal

Trial locations and contacts

2 sites in 1 country.

United States2 sites

University of Michigan
Ann Arbor, Michigan, 48109
Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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

Read the detailed description

The clinical protocol for the study is designed to compare the performance of the Atmo Motility Gas Capsule System to the predicate device, the SmartPill GI Monitoring System, in patients with chronic GI symptoms suggestive of GI motility disorders (specifically gastroparesis and slow transit constipation), in order to demonstrate substantial equivalence. This study will involve the recruitment of symptomatic participants from a population that is representative of that for which the device is intended.

The primary objective of this study is the assessment of the agreement of Atmo Motility and SmartPill Systems' results with regards to both GET and CTT. The SmartPill is the accepted gold standard test for GI motility transit time analysis. Device agreement will be primarily examined through Bland-Altman analyses for GET and CTT measurements from the Atmo Motility and SmartPill Systems.

Conditions: Gastroparesis, Slow Transit Constipation, IBS
Being tested: Atmo Motility Gas Capsule System, SmartPill Monitoring System
Medical subject headings: Gastroparesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Atmo Motility Gas Capsule SystemDevice
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.
SmartPill Monitoring SystemDevice
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.

Study groups in NCT05718505
Study group	Role	What they receive
SmartPill Monitoring System	Active comparator	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. Receives: Device: SmartPill Monitoring System
Atmo Motility Gas Capsule System	Experimental	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. Receives: Device: Atmo Motility Gas Capsule System

What is being measured

The primary outcome is the main question the study is designed to answer.

GET as measured by the Atmo Motility System
Interpretation of gastric emptying time by central readers using the Atmo Motility System
Measured: Day 1 to Day 10
GET as measured by the SmartPill System
Interpretation of gastric emptying time by central readers of the SmartPill System
Measured: Day 1 to Day 10
CTT as measured by the Atmo Motility System
Interpretation of colonic transit time by central readers using the Atmo Motility System
Measured: Day 1 to Day 10
CTT as measured by the SmartPill System
Interpretation of colonic transit time by central readers using the SmartPill System
Measured: Day 1 to Day 10

Secondary outcomes (7)

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
Measured: Day 1 to Day 10
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
Measured: Day 1 to Day 10
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
Measured: Day 1 to Day 10
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
Measured: Day 1 to Day 10
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
Measured: Day 1 to Day 10
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
Measured: Day 1 to Day 10
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
Measured: Day 0 to Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 202317 May 2024

First posted8 Feb 2023
Study start5 Jun 2023
Primary completion15 Dec 2023
Study completion17 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for GastroparesisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Model description: All participants will ingest the investigational and predicate device in a tandem ingestion. The order of device ingestion will be randomized, controlled centrally via an Electronic Data Capture system.
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 209 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05718505
Sponsor's protocol ID: A0015
Status last verified: Oct 2026
First submitted: 24 Jan 2023
Last updated: 28 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

Kuo B, Lee AA, Abell T, Attaluri A, Cline M, Hasler W, Ho V, Lembo AJ, Masoud A, McCallum R, Moshiree B, Quigley EMM, Rao SSC, Stocker A, Sanchez M, Sarosiek I, Surjanhata B, Zhou J, Chey WD. The Assessment of Gastrointestinal Transit by the Atmo Capsule: A Comparison With the SmartPill Capsule. Clin Gastroenterol Hepatol. 2025 Aug;23(9):1633-1641.e8. doi: 10.1016/j.cgh.2024.12.013. Epub 2025 Jan 30.
PubMed 39889900

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Recruiting
To Study the Efficacy and Safety of Medtronic 780G Insulin Pump in People With Gastroparesis and Type 1 Diabetes.
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All Gastroparesis trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT05718505
Acronym / sponsor ID: A0015
Conditions: Gastroparesis, Slow Transit Constipation, IBS
Study type: Interventional
Recruitment status: Completed
Enrolment: 209 participants (actual)
Lead sponsor: Atmo Biosciences Pty LtdIndustry (pharma, biotech, devices)
Study start: 5 Jun 2023 (actual)
Primary completion: 15 Dec 2023 (actual)
Study completion: 17 May 2024 (actual)
First posted: 8 Feb 2023 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Other
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (outcomes assessor)
Number of arms: 2
Model description: All participants will ingest the investigational and predicate device in a tandem ingestion. The order of device ingestion will be randomized, controlled centrally via an Electronic Data Capture system.

Arm	Type	Receives
SmartPill Monitoring System	Active comparator	Device: SmartPill Monitoring SystemThe 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.
Atmo Motility Gas Capsule System	Experimental	Device: Atmo Motility Gas Capsule SystemThe 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.

Who may qualify

Ages: 22 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 listed)

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:
Participant or their legally authorized representative has the ability to provide informed consent and comply with the protocol.

Key exclusion criteria (20 listed)

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)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Atmo Motility Gas Capsule SystemThe 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	Atmo Motility Gas Capsule System
SmartPill Monitoring SystemThe 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.	Device	SmartPill Monitoring System

Primary outcome

GET as measured by the Atmo Motility System
Time frame: Day 1 to Day 10
Interpretation of gastric emptying time by central readers using the Atmo Motility System
GET as measured by the SmartPill System
Time frame: Day 1 to Day 10
Interpretation of gastric emptying time by central readers of the SmartPill System
CTT as measured by the Atmo Motility System
Time frame: Day 1 to Day 10
Interpretation of colonic transit time by central readers using the Atmo Motility System
CTT as measured by the SmartPill System
Time frame: Day 1 to Day 10
Interpretation of colonic transit time by central readers using the SmartPill System

7 secondary outcomes

Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by Atmo Motility System
Time frame: Day 1 to Day 10
Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by SmartPill
Time frame: Day 1 to Day 10
Classification as rapid or not for all transit times: GET, SBTT, OCTT, SLBTT, CTT and WGTT as determined by the Atmo Motility System
Time frame: Day 1 to Day 10
Classification as rapid or not for all transit times: GET, SBTT, OCTT, SLBTT, CTT and WGTT as determined by SmartPill
Time frame: Day 1 to Day 10
Continuous transit time measures for SBTT, OCTT, SLBTT and WGTT for SmartPill and Atmo Motility Systems
Time frame: Day 1 to Day 10
Qualitative description of per participant hydrogen and carbon dioxide gas profiles as determined by the Atmo Motility System
Time frame: Day 1 to Day 10
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
Time frame: Day 0 to Day 31

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Oct 2026.
Derived from this study: PubMed 39889900Kuo B, Lee AA, Abell T, Attaluri A, Cline M, Hasler W, Ho V, Lembo AJ, Masoud A, McCallum R, Moshiree B, Quigley EMM, Rao SSC, Stocker A, Sanchez M, Sarosiek I, Surjanhata B, Zhou J, Chey WD. The Assessment of Gastrointestinal Transit by the Atmo Capsule: A Comparison With the SmartPill Capsule. Clin Gastroenterol Hepatol. 2025 Aug;23(9):1633-1641.e8. doi: 10.1016/j.cgh.2024.12.013. Epub 2025 Jan 30.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Braden Kuo, MD principal investigator

Massachusetts General Hospital

William Chey, MD principal investigator

University of Michigan

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

GET as measured by the Atmo Motility System (time frame: Day 1 to Day 10). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05718505, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Oct 2026.