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

Primary Purpose

Gastroparesis, Slow Transit Constipation, IBS

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Atmo Motility Gas Capsule System
SmartPill Monitoring System
Sponsored by
Atmo Biosciences Pty Ltd
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Gastroparesis

Eligibility Criteria

22 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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: A. 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. Exclusion Criteria: 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. 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

Sites / Locations

  • Massachusetts General HospitalRecruiting
  • University of MichiganRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

SmartPill Monitoring System

Atmo Motility Gas Capsule System

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

GET as measured by the Atmo Motility System
Interpretation of gastric emptying time by central readers using the Atmo Motility System
GET as measured by the SmartPill System
Interpretation of gastric emptying time by central readers of the SmartPill System
CTT as measured by the Atmo Motility System
Interpretation of colonic transit time by central readers using the Atmo Motility System
CTT as measured by the SmartPill System
Interpretation of colonic transit time by central readers using the SmartPill System

Secondary Outcome Measures

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
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
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
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
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
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
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

Full Information

First Posted
January 24, 2023
Last Updated
July 18, 2023
Sponsor
Atmo Biosciences Pty Ltd
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1. Study Identification

Unique Protocol Identification Number
NCT05718505
Brief Title
Comparison of the Atmo Motility Gas Capsule System to the Reference Standard
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 5, 2023 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
April 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Atmo Biosciences Pty Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gastroparesis, Slow Transit Constipation, IBS

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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
Outcomes Assessor
Allocation
Randomized
Enrollment
171 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SmartPill Monitoring System
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Atmo Motility Gas Capsule System
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Atmo Motility Gas Capsule System
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
SmartPill Monitoring System
Intervention Description
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.
Primary Outcome Measure Information:
Title
GET as measured by the Atmo Motility System
Description
Interpretation of gastric emptying time by central readers using the Atmo Motility System
Time Frame
Day 1 to Day 10
Title
GET as measured by the SmartPill System
Description
Interpretation of gastric emptying time by central readers of the SmartPill System
Time Frame
Day 1 to Day 10
Title
CTT as measured by the Atmo Motility System
Description
Interpretation of colonic transit time by central readers using the Atmo Motility System
Time Frame
Day 1 to Day 10
Title
CTT as measured by the SmartPill System
Description
Interpretation of colonic transit time by central readers using the SmartPill System
Time Frame
Day 1 to Day 10
Secondary Outcome Measure Information:
Title
Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by Atmo Motility System
Description
Classification of all gut transit times as either delayed or not as measured by the Atmo System
Time Frame
Day 1 to Day 10
Title
Classification as delayed or not for GI transit times: SBTT, OCTT, SLBTT and WGTT as determined by SmartPill
Description
Classification of all gut transit times as either delayed or not as measured by SmartPill
Time Frame
Day 1 to Day 10
Title
Classification as rapid or not for all transit times: GET, SBTT, OCTT, SLBTT, CTT and WGTT as determined by the Atmo Motility System
Description
Classification of all gut transit times as either rapid or not as measured by Atmo
Time Frame
Day 1 to Day 10
Title
Classification as rapid or not for all transit times: GET, SBTT, OCTT, SLBTT, CTT and WGTT as determined by SmartPill
Description
Classification of all gut transit times as either rapid or not as measured by SmartPill
Time Frame
Day 1 to Day 10
Title
Continuous transit time measures for SBTT, OCTT, SLBTT and WGTT for SmartPill and Atmo Motility Systems
Description
Measurement of gut transit times as as measured by the SmartPill and Atmo Systems, expressed in hours:minutes
Time Frame
Day 1 to Day 10
Title
Qualitative description of per participant hydrogen and carbon dioxide gas profiles as determined by the Atmo Motility System
Description
Description of gas production profiles as measured by the Atmo Motility System
Time Frame
Day 1 to Day 10
Title
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
Description, number and outcomes of all adverse events, serious adverse events and others, summarized by recruitment site
Time Frame
Day 0 to Day 31

10. Eligibility

Sex
All
Minimum Age & Unit of Time
22 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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: A. 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. Exclusion Criteria: 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. 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Holly Pedersen
Phone
+61 437 719950
Email
holly.pedersen@atmobiosciences.com
First Name & Middle Initial & Last Name or Official Title & Degree
Michelle Butler
Phone
+1 8582206904
Email
michelle.butler@atmobiosciences.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Braden Kuo, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
William Chey, MD
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Braden Kuo, MD
Email
bkuo@mgh.harvard.edu
First Name & Middle Initial & Last Name & Degree
Brian Surjanhata, MD
Email
bsurjanhata@mgh.harvard.edu
Facility Name
University of Michigan
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William Chey, MD
Email
wchey@med.umich.edu
First Name & Middle Initial & Last Name & Degree
Allen Lee, MD
Email
allenlee@med.umich.edu

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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