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Trial registered on ANZCTR


Registration number
ACTRN12619001219178
Ethics application status
Approved
Date submitted
5/08/2019
Date registered
3/09/2019
Date last updated
3/09/2019
Date data sharing statement initially provided
3/09/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Comparison of gut transit measurements for the Atmo Gas Capsule with the Smart Pill
Scientific title
Comparison of regional transit measurements for the Atmo Capsule with those of a gold standard (Smart Pill)
Secondary ID [1] 298923 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gastrointestinal function 314173 0
Condition category
Condition code
Oral and Gastrointestinal 312317 312317 0 0
Normal oral and gastrointestinal development and function

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The study will involve simultaneous ingestion of two medical devices - the Atmo gas capsule and the SmartPill capsule. This will be completed only once.

Following an overnight fast (water only for at least 8 hours), participants will attend the Department of Gastroenterology, Alfred Hospital where a simultaneous transit study with the SmartPill capsule will be performed with the gas-sensing capsule. Participants will first be asked to be consume a cereal bar with 200 mL water within a 5 min timeframe, followed immediately by ingestion of both the SmartPill and Atmo gas capsule, simultaneously. They will fast for the next 6 hours, then consume their normal meals for the rest of the day.

Once the Atmo capsule is swallowed, it transmits information about individual gases (hydrogen, carbon dioxide, methane and oxygen) and temperature every 5 minutes to an external receiver worn around the participant's waist. The SmartPill capsule on the other hand, transmits information every 20 seconds regarding pH, pressure and temperature to an external recorder. Data recording will then be ceased once the capsule has been passed (confirmed visually in the toilet bowl or signal loss from both capsules after a bowel movement) from the body. Both the Atmo gas capsule and SmartPill device are simple, safe and non-invasive methods for learning about the inside of the bowel without the necessity of putting tubes into the bowel.
Intervention code [1] 315204 0
Treatment: Devices
Comparator / control treatment
The SmartPill capsule is swallowed, then transmits information every 20 seconds regarding pH, pressure and temperature to an external recorder. Data recording will be ceased once the capsule has been passed (confirmed visually in the toilet bowl or signal loss indicated on the receiver after a bowel movement) from the body.

The SmartPill device has been approved by the Therapeutics Good Australia for easurement of passage rate, pH and pressure within the gastrointestinal tract. It has also been approved as an investigational device by international regulatory authorities including the US FDA and European CE mark.
Control group
Active

Outcomes
Primary outcome [1] 320952 0
Time for Atmo Gas Capsule to reaches the ileo-caecal junction, indicated by fall in measured oxygen concentration, compared to that of gold standard (Smartpill). This comparison is one time measurement and the primary outcome.
Timepoint [1] 320952 0
Estimated between 1-2 days post ingestion of capsules.
Secondary outcome [1] 373489 0
Comparison of whole gut transit (time from ingestion) between the Atmo Gas Capsule and Smartpill, indicated by loss of signal to receiver after a bowel motion.
Timepoint [1] 373489 0
Estimated 1-2 days post ingestion of capsules

Eligibility
Key inclusion criteria
Healthy volunteers without known gastrointestinal conditions
Minimum age
18 Years
Maximum age
55 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy, body mass index >27 kg/m2, previous abdominal surgery, history of gastrointestinal,endocrine or neurogenic disorders known to influence gastrointestinal motility (including Crohn's disease, diverticulosis, bowel obstruction), swallowing difficulties, receiving diathermy, implantable devices such as a pacemaker, antibiotic, pre-, probiotic use in the last 4 weeks, radiation enteritis, gastric bezoar, suspected or known strictures and current participation in other trials.

Study design
Purpose of the study
Diagnosis
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Bio-equivalence
Statistical methods / analysis
The key study upon which the accuracy of the pH-motility capsule was established compared it with scintigraphy, and used a sample of greater than 150. In contrast, the present study is using very similar techniques (capsules with a similar density and size) delivered simultaneously. It is anticipated that sufficient pilot data to determine the comparability of the two capsules will be obtained from 50 completed studies. Assuming a drop-out rate of about 20%, a sample size will be 60 healthy volunteers.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
22/08/2019
Date of last participant enrolment
Anticipated
21/08/2020
Actual
Date of last data collection
Anticipated
21/08/2020
Actual
Sample size
Target
60
Accrual to date
1
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 14434 0
The Alfred - Melbourne
Recruitment postcode(s) [1] 27444 0
3004 - Melbourne

Funding & Sponsors
Funding source category [1] 303470 0
Commercial sector/Industry
Name [1] 303470 0
Atmo Biosciences
Country [1] 303470 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 303524 0
None
Name [1] 303524 0
Address [1] 303524 0
Country [1] 303524 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 304000 0
Monash University Human Research Ethics Committee
Ethics committee address [1] 304000 0
Room 111, Chancellery Building D,
26 Sports Walk, Clayton Campus
Research Office
Monash University VIC 3800
Ethics committee country [1] 304000 0
Australia
Date submitted for ethics approval [1] 304000 0
27/05/2019
Approval date [1] 304000 0
10/07/2019
Ethics approval number [1] 304000 0
18354

Summary
Brief summary
When swallowed, the Atmo gas capsule consists of several gas and temperature sensors which provides information on oxygen concentrations, and therefore, passage of the capsule between aerobic (small intestine) and anaerobic regions (large intestine). That way, regional transit measurements can be accurately derived. To validate this device, simultaneous ingestion of this and an existing device measuring pH (SmartPill) to determine time comparison of gut transit will be conducted to show equivalence of the two devices in transit measurements.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 95510 0
Prof Peter Gibson
Address 95510 0
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 95510 0
Australia
Phone 95510 0
+61 399030640
Fax 95510 0
Email 95510 0
[email protected]
Contact person for public queries
Name 95511 0
Emma Halmos
Address 95511 0
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 95511 0
Australia
Phone 95511 0
+61 399030270
Fax 95511 0
Email 95511 0
[email protected]
Contact person for scientific queries
Name 95512 0
Emma Halmos
Address 95512 0
Level 6 The Alfred Centre
99 Commercial Rd
Melbourne VIC 3004
Country 95512 0
Australia
Phone 95512 0
+61 399030270
Fax 95512 0
Email 95512 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Data will by only be available via manuscript for publication in an international peer reviewed journal.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
Basic resultsNo 378113-(Uploaded-20-10-2022-12-58-53)-Basic results summary.docx
Plain language summaryNo The gas-sensing capsule is a safe and well-tolerat... [More Details]
Study results articleYes Online publication 09 September 2022 Thwaites, PA... [More Details]

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseComparison of gastrointestinal landmarks using the gas-sensing capsule and wireless motility capsule.2022https://dx.doi.org/10.1111/apt.17216
N.B. These documents automatically identified may not have been verified by the study sponsor.