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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT04977063




Registration number
NCT04977063
Ethics application status
Date submitted
28/06/2021
Date registered
26/07/2021
Date last updated
20/07/2023

Titles & IDs
Public title
Atmo SmartPill Comparison in Gastroparetic and Slow Transit Constipation Patients
Scientific title
Comparison of Gastrointestinal Transit Measurements for the Atmo Capsule With Those of the Gold Standard (SmartPill) in Gastroparesis and Slow Transit Constipation Patients
Secondary ID [1] 0 0
ETH01064
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastroparesis 0 0
Slow Transit 0 0
Condition category
Condition code
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Neurological 0 0 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Atmo gas capsule
Treatment: Devices - SmartPill

Other: SmartPill and Atmo capsule - The SmartPill and Atmo gas capsule will be tested simultaneously. This will allow the ability of the Atmo gas capsule to measure gastrointestinal transit time to be compared to the SmartPill. The order of swallowing will be randomised using a computer-generated list. The two capsules will be swallowed within 5 minutes of each other


Treatment: Devices: Atmo gas capsule
The Atmo Gas Capsule measures the capsules location and motility/transit times through gas sensing capabilities

Treatment: Devices: SmartPill
The SmartPill measures the capsules location and motility/transit times through pH sensing
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Regional gastrointestinal metrics measured by Atmo gas capsule
Timepoint [1] 0 0
2 years
Primary outcome [2] 0 0
Regional gastrointestinal metrics measured by SmartPill
Timepoint [2] 0 0
2 years

Eligibility
Key inclusion criteria
- Diagnosed with gastroparesis (idiopathic or diabetic) for at least 12 weeks (based on
scintigraphy results) and able to eat orally.

- Diagnosed with slow transit constipation for at least 12 weeks (exclusion of
constipation caused by structural abnormalities with colonoscopy, and confirmation of
slow transit by 'marker studies' such as scintigraphy, radiolabelled or opaque X-ray
study). Participant would have at least 1 bowel motion per week (either assisted or
unassisted by medication).

- No evidence of metabolic disease (hypothyroidism, uncontrolled diabetes [hemoglobin
A1c >10% within the past 6 months], electrolyte imbalance).

- An endoscopy or gastrointestinal barium series within the past 3 years showing no
organic disease that is potentially causative of symptoms.

- Ability to stop medications that may alter gastric pH (such as proton pump inhibitors)
for 3 days prior to and during study.

- Ability to stop medications that may alter gastrointestinal motility (GLP-1 angonists,
anticholinergics, cannabinoids, metformin, antispasmodic, prokinetics) for 3 days
prior to and during study.

- Ability to stop antibiotic, probiotic and, prebiotic supplements 7 days before prior
to and during study.

- Ability to stop laxatives (docusate, lactulose, sorbitol, senna, bisacodyl),
suppositories (glycerin), and enema 3 days prior to and during the study.

- Does not require a MRI scan during the duration of this study
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Previous abdominal and/or pelvic surgery

- History of diverticulitis, diverticular stricture, and other intestinal strictures

- Chronic daily use of nonsteroidal anti-inflammatory drugs (ibuprofen, naproxen, etc.)

- Pregnant or nursing

- Patients on long-acting glucagon-like peptide (GLP-1)

- Implantable devices (e.g. pacemaker, defibrillator) [continuous glucose monitors are
permitted].

- History of bezoar formation

- Dysphagia to solid foods

- Gastric/jejunal feeding tubes

Study design
Purpose of the study
Diagnosis
Allocation to intervention
N/A
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
15/08/2021
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
15/03/2023
Sample size
Target
Accrual to date
Final
53
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Blacktown Hospital - Blacktown
Recruitment hospital [2] 0 0
School of Medicine, Western Sydney University - Campbelltown
Recruitment hospital [3] 0 0
Alfred Hospital - Melbourne
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2560 - Campbelltown
Recruitment postcode(s) [3] 0 0
3004 - Melbourne

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Atmo Biosciences Pty Ltd
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
University of Western Sydney
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
This study will compare gastrointestinal transit time measured by the SmartPill and the Atmo
gas capsule in patients with gastrointestinal motility disorders. Both of these devices allow
gastrointestinal transit time to be measured, however the SmartPill senses pH changes whereas
the Atmo Capsule measures gas profiles. A total of 60 participants (30 diagnosed with
gastroparesis, 30 with slow transit constipation) will attend Macarthur Clinical School at
Western Sydney University after an overnight fast. Participants will consume a standardised
meal before ingesting the SmartPill and Atmo Capsule. Each participant will carry a data
receiver until passage of the capsules. Anatomical landmarks will be defined by pH changes
(SmartPill) or oxygen profiles (Atmo Capsule). Statistical analysis will be performed via
linear regression and degrees of agreement for measurements between the two devices. Primary
end-points will be the agreement between gastric emptying, small intestinal and colonic
transit times generated by the devices.
Trial website
https://clinicaltrials.gov/ct2/show/NCT04977063
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Jerry Zhou, PhD BSc
Address 0 0
School of Medicine, Western Sydney University
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT04977063