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Trial registered on ANZCTR
Registration number
ACTRN12618001964202
Ethics application status
Approved
Date submitted
26/11/2018
Date registered
5/12/2018
Date last updated
5/03/2019
Date data sharing statement initially provided
5/12/2018
Type of registration
Prospectively registered
Titles & IDs
Public title
Feasibility study of a novel stoma device
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Scientific title
Feasibility study of a novel device for recycling effluent from stomas and fistulas
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Secondary ID [1]
296708
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None
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Universal Trial Number (UTN)
U1111-1222-1403
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Trial acronym
n/a
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Linked study record
n/a
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Health condition
Health condition(s) or problem(s) studied:
stoma
310560
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enterocutaneous fistula
310561
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Condition category
Condition code
Oral and Gastrointestinal
309274
309274
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Intervention:
- Initiation of device for recycling stoma and fistula effluent.
- A tube will be inserted into the stoma orifice to enable stoma output recycling.
Who will deliver the intervention:
- The intervention will be delivered by a member of the trial team initially, and may subsequently be self-delivered by a patient.
Number of times to be delivered:
- The intervention will be delivered over increasing periods of time during the trial, initially for single short periods (5-10 minutes), then progressively increasing usage to trials over 3 days and eventually over 6 week periods.
Setting:
- hospital and/or home environment
Strategies to monitor adherence:
- research team monitoring / observations initially and later patient self-reporting.
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Intervention code [1]
313019
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Treatment: Devices
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Comparator / control treatment
Non-controlled (first-in-human) study
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Control group
Uncontrolled
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Outcomes
Primary outcome [1]
308247
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Composite primary outcome:
- Technical success / feasibility - assessed via direct patient observation and investigator completed proforma.
- Measured outcome is successful completion (binary) and duration (minutes) of stoma or fistula recycling as the initial technical endpoint of interest.
- Success also measured by completed use in conjunction with a standard commercial stoma appliance with observations of any skin irritation.
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Assessment method [1]
308247
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Timepoint [1]
308247
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Timepoints:
- Initially the device will be used over single episodes / short periods of approximately 5-30 minutes.
- On technical success, this timepoint will be extended toward 12-24h, then 24-72h, and then usage over periods of up to 6-12 weeks.
- Assessments will be continuous monitored observation during the initial phase, then extended to patient daily self-reported observations.
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Secondary outcome [1]
354373
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Patient tolerance / acceptability
Measured with a stoma-related quality of life score
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Assessment method [1]
354373
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Timepoint [1]
354373
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Timepoint will vary by patients
- for initial periods, may be performed intermittently and daily
- once timeframe of use is extended, may be performed weekly.
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Secondary outcome [2]
354595
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Pilot clinical outcomes
- observational composite outcome measured by recording of clinical course including monitoring of any blood tests performed, episodes of dehydration, registering of any hospital admissions, and clinical course at time of stoma closure if relevant.
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Assessment method [2]
354595
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Timepoint [2]
354595
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Continuously monitored in observational fashion throughout the study period.
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Eligibility
Key inclusion criteria
Temporary stoma of the small intestine or enterocutaneous fistula with two orifices
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Distal leak / Distal obstruction / Current pregnancy / Unable to consent / Unable to independently manage stoma cares / Previous or current Clostridium difficile colitis
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Non-randomised trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
N/A
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
N/A
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Single group
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Other design features
Feasibility trial
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Phase
Not Applicable
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Type of endpoint/s
Safety/efficacy
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Statistical methods / analysis
Technical endpoints only. No statistics on clinical outcomes.
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
5/03/2019
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Actual
24/02/2019
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Date of last participant enrolment
Anticipated
1/12/2020
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
30
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Accrual to date
1
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Final
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Recruitment outside Australia
Country [1]
21069
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New Zealand
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State/province [1]
21069
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Auckland
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Funding & Sponsors
Funding source category [1]
301288
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Government body
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Name [1]
301288
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NZ MedTech CoRE - An NZ Governtment Funded Centre of Research Excellence
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Address [1]
301288
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Auckland Bioengineering Institute, The University of Auckland,
70 Symonds Street,
Auckland 1142
New Zealand
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Country [1]
301288
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Auckland Bioengineering Institute, The University of Auckland,
70 Symonds Street,
Auckland 1142
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
300940
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None
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Name [1]
300940
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Address [1]
300940
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Country [1]
300940
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
302030
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NZ HDEC - Northern B Health and Disability Ethics Committee
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Ethics committee address [1]
302030
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Ministry of Heath
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
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Ethics committee country [1]
302030
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New Zealand
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Date submitted for ethics approval [1]
302030
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11/10/2018
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Approval date [1]
302030
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07/02/2019
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Ethics approval number [1]
302030
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Summary
Brief summary
Title:
- Trial of a device to enable recycling of stoma and fistula effluent.
Description:
- To test and refine a device that can safely and effectively recycle stoma and enterocutaneous fistula effluent, is well-tolerated amongst patients and minimises the stoma-associated harms and costs.
Hypothesis:
- The device can safely and effectively recycle stoma and enterocutaneous fistula effluent in a manner that is well tolerated by patients.
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Trial website
N/A
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Trial related presentations / publications
N/A
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Public notes
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Contacts
Principal investigator
Name
88898
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A/Prof Greg O'Grady
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Address
88898
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Department of Surgery, University of Auckland
Auckland Clinical Campus
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1148
New Zealand
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Country
88898
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New Zealand
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Phone
88898
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+64 274222989
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Fax
88898
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Email
88898
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[email protected]
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Contact person for public queries
Name
88899
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A/Prof Greg O'Grady
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Address
88899
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Department of Surgery, University of Auckland
Auckland Clinical Campus
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1148
New Zealand
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Country
88899
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New Zealand
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Phone
88899
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+64 274222989
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Fax
88899
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Email
88899
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[email protected]
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Contact person for scientific queries
Name
88900
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A/Prof Greg O'Grady
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Address
88900
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Department of Surgery, University of Auckland
Auckland Clinical Campus
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1148
New Zealand
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Country
88900
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New Zealand
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Phone
88900
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+64 274222989
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Fax
88900
0
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Email
88900
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[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
Technical feasibility trial - for purposes of device modification/improvement. Potential for possible commercialisation of this device in future limits release of individual patient data at this time.
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What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
Documents added manually
No documents have been uploaded by study researchers.
Documents added automatically
No additional documents have been identified.
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