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Feasibility study of a novel stoma device

Feasibility study of a novel device for recycling effluent from stomas and fistulas

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12618001964202
Acronym
n/a
Enrollment
1
Registered
2018-12-05
Start date
2019-02-24
Completion date
2020-12-01
Last updated
2019-07-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

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.

Interventions

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

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.

Sponsors

University of Auckland
Lead SponsorUniversity

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Temporary stoma of the small intestine or enterocutaneous fistula with two orifices

Exclusion criteria

Distal leak / Distal obstruction / Current pregnancy / Unable to consent / Unable to independently manage stoma cares / Previous or current Clostridium difficile colitis

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026