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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
Scientific title
Feasibility study of a novel device for recycling effluent from stomas and fistulas
Secondary ID [1] 296708 0
None
Universal Trial Number (UTN)
U1111-1222-1403
Trial acronym
n/a
Linked study record
n/a

Health condition
Health condition(s) or problem(s) studied:
stoma 310560 0
enterocutaneous fistula 310561 0
Condition category
Condition code
Oral and Gastrointestinal 309274 309274 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 313019 0
Treatment: Devices
Comparator / control treatment
Non-controlled (first-in-human) study
Control group
Uncontrolled

Outcomes
Primary outcome [1] 308247 0
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.
Timepoint [1] 308247 0
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.
Secondary outcome [1] 354373 0
Patient tolerance / acceptability
Measured with a stoma-related quality of life score
Timepoint [1] 354373 0
Timepoint will vary by patients
- for initial periods, may be performed intermittently and daily
- once timeframe of use is extended, may be performed weekly.
Secondary outcome [2] 354595 0
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.
Timepoint [2] 354595 0
Continuously monitored in observational fashion throughout the study period.

Eligibility
Key inclusion criteria
Temporary stoma of the small intestine or enterocutaneous fistula with two orifices
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Distal leak / Distal obstruction / Current pregnancy / Unable to consent / Unable to independently manage stoma cares / Previous or current Clostridium difficile colitis

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



Intervention assignment
Single group
Other design features
Feasibility trial
Phase
Not Applicable
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis
Technical endpoints only. No statistics on clinical outcomes.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 21069 0
New Zealand
State/province [1] 21069 0
Auckland

Funding & Sponsors
Funding source category [1] 301288 0
Government body
Name [1] 301288 0
NZ MedTech CoRE - An NZ Governtment Funded Centre of Research Excellence
Address [1] 301288 0
Auckland Bioengineering Institute, The University of Auckland,
70 Symonds Street,
Auckland 1142
New Zealand
Country [1] 301288 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Auckland Bioengineering Institute, The University of Auckland,
70 Symonds Street,
Auckland 1142
New Zealand
Country
New Zealand
Secondary sponsor category [1] 300940 0
None
Name [1] 300940 0
Address [1] 300940 0
Country [1] 300940 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302030 0
NZ HDEC - Northern B Health and Disability Ethics Committee
Ethics committee address [1] 302030 0
Ministry of Heath
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140
Ethics committee country [1] 302030 0
New Zealand
Date submitted for ethics approval [1] 302030 0
11/10/2018
Approval date [1] 302030 0
07/02/2019
Ethics approval number [1] 302030 0

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.
Trial website
N/A
Trial related presentations / publications
N/A
Public notes

Contacts
Principal investigator
Name 88898 0
A/Prof Greg O'Grady
Address 88898 0
Department of Surgery, University of Auckland
Auckland Clinical Campus
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1148
New Zealand
Country 88898 0
New Zealand
Phone 88898 0
+64 274222989
Fax 88898 0
Email 88898 0
greg.ogrady@auckland.ac.nz
Contact person for public queries
Name 88899 0
A/Prof Greg O'Grady
Address 88899 0
Department of Surgery, University of Auckland
Auckland Clinical Campus
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1148
New Zealand
Country 88899 0
New Zealand
Phone 88899 0
+64 274222989
Fax 88899 0
Email 88899 0
greg.ogrady@auckland.ac.nz
Contact person for scientific queries
Name 88900 0
A/Prof Greg O'Grady
Address 88900 0
Department of Surgery, University of Auckland
Auckland Clinical Campus
Level 12
Auckland City Hospital Support Building
Park Road
Grafton
Auckland 1148
New Zealand
Country 88900 0
New Zealand
Phone 88900 0
+64 274222989
Fax 88900 0
Email 88900 0
greg.ogrady@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.
What supporting documents are/will be available?
No other documents available
Summary results
No Results