NCT05718505

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
209

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 24, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 8, 2023

Completed
4 months until next milestone

Study Start

First participant enrolled

June 5, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 15, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2024

Completed
Last Updated

January 10, 2024

Status Verified

January 1, 2024

Enrollment Period

6 months

First QC Date

January 24, 2023

Last Update Submit

January 9, 2024

Conditions

GastroparesisSlow Transit ConstipationIBS

Outcome Measures

Primary Outcomes (4)

  • GET as measured by the Atmo Motility System

    Interpretation of gastric emptying time by central readers using the Atmo Motility System

    Day 1 to Day 10

  • GET as measured by the SmartPill System

    Interpretation of gastric emptying time by central readers of the SmartPill System

    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

    Day 1 to Day 10

  • CTT as measured by the SmartPill System

    Interpretation of colonic transit time by central readers using the SmartPill System

    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

    Day 1 to Day 10

  • Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by SmartPill

    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

    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

    Day 1 to Day 10

  • Continuous transit time measures for SBTT, OCTT, SLBTT and WGTT for SmartPill and Atmo Motility Systems

    Day 1 to Day 10

  • +2 more secondary outcomes

Study Arms (2)

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.

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.

Device: Atmo Motility Gas Capsule System

Interventions

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.

Atmo Motility Gas Capsule System
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.

SmartPill Monitoring System

Eligibility Criteria

Age22 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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
  • 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.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (1)

  • 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.

    PMID: 39889900DERIVED

MeSH Terms

Conditions

Gastroparesis

Interventions

Drug Delivery Systems

Condition Hierarchy (Ancestors)

Stomach DiseasesGastrointestinal DiseasesDigestive System DiseasesParalysisNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug TherapyTherapeutics

Study Officials

  • Braden Kuo, MD

    Massachusetts General Hospital

    PRINCIPAL INVESTIGATOR

  • William Chey, MD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 24, 2023

First Posted

February 8, 2023

Study Start

June 5, 2023

Primary Completion

December 15, 2023

Study Completion

April 1, 2024

Last Updated

January 10, 2024

Record last verified: 2024-01

Data Sharing

IPD Sharing
Will not share

Locations

US(2)