IleostomyU366NCT01782196
A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy
A study testing Enhanced one piece drainable pouch with Type A mouldable adhesive and Enhanced one piece drainable pouch with Type B mouldable adhesive in people with Ileostomy, run by ConvaTec Inc. at 5 sites in United Kingdom.
Trial summary
Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy
- What is being tested?
- Enhanced one piece drainable pouch with Type A mouldable adhesive and Enhanced one piece drainable pouch with Type B mouldable adhesive
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- Oct 2012to Mar 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects who provide written informed consent.
- Subjects who have an ileostomy and be over 18 years of age.
- Subjects who are currently using a one piece drainable pouch.
- Subjects who have unbroken peri-stomal skin (healthy normal skin defined as "normal unbroken skin with certain variations normal for this subject" to L1 on the SACs Instrument Scale).
- Subjects with a stoma considered 'normal' in appearance in accordance with the stoma, colour, moisture and structure rating scales.
- Subjects who are willing to attend clinic for a maximum of 5 separate occasions for scheduled visits.
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- Subjects who are willing to discontinue the use of pastes, adhesive strips and rings/seals used to seal the area between the skin barrier wafer and stoma during the use of the study device.
- Subjects who other than their ileostomy considered to have a healthy/stable health status.
- Subjects who have good manual dexterity and be able to take care of their stoma independently, or have a consistent care provider.
- Subjects who are willing and able to complete a diary card for the duration of the study.
Who cannot join
- Subjects with a history of sensitivity to any one of the ostomy products or the components being studied.
- Subjects with stoma duration of less than 3 months.
- Subjects who currently use a belt with their usual appliance.
- Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
- Subjects who require convexity or other skin fillers (pastes, rings, seals) to even undulations of the skin.
- Subjects undergoing chemotherapy or radiotherapy.
- Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Princess of Wales Hospital
Bridgend, Mid Glam, CF31 1RQ
Homerton University Hospital
London, E9 6SR
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
Manor Hospital
Walsall, West Midlands, WS2 9PS
Wrexham Maelor Hospital
Wrexham, North Wales, LL13 7TD
About this study
Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.
- Conditions
- Ileostomy
- Being tested
- Enhanced one piece drainable pouch with Type A mouldable adhesive, Enhanced one piece drainable pouch with Type B mouldable adhesive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Enhanced one piece drainable pouch with Type A mouldable adhesiveDevice
Enhanced one piece drainable pouch with Type B mouldable adhesiveDevice
| Study group | Role | What they receive |
|---|---|---|
| Type A Pouch followed by Type B pouch | Experimental | Enhanced one piece drainable pouch with Type A mouldable adhesive for Stage 1 and 2 followed by pouch with Type B mouldable adhesive for Stage 3 Receives: Device: Enhanced one piece drainable pouch with Type A mouldable adhesive; Device: Enhanced one piece drainable pouch with Type B mouldable adhesive |
| Type B Pouch followed by Type A pouch | Experimental | Enhanced one piece drainable pouch with Type B mouldable adhesive for Stage 1 and 2 followed by pouch with Type A mouldable adhesive for Stage 3 Receives: Device: Enhanced one piece drainable pouch with Type A mouldable adhesive; Device: Enhanced one piece drainable pouch with Type B mouldable adhesive |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions
The primary objective of this study is to evaluate the safety of the enhanced one piece drainable pouch with a mouldable skin barrier wafer and two alternate adhesives in subjects with an ileostomy.
Measured: 59 days
Secondary outcomes (1)
Performance
Performance will be evaluated by comparing the following categories to the subject's usual pouching system
Wear time Adhesion Ease of Use Mouldability Comfort and flexibility Security Skin protection Wafer seal integrity Undermining Filter performance Accessory usage
At the end of the study a comparative assessment of the subject's usual pouching system and the study pouch will be made.
Measured: 59 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startOct 2012
- Primary completionMar 2013
- Study completionMar 2013
Why it stopped: Leakage
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IleostomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01782196
- Sponsor's protocol ID
- CC-0512-12-U366
- Acronym
- U366
- Status last verified
- Jul 2013
- First submitted
- 19 Dec 2012
- Last updated
- 3 Jul 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II Multi Centre Study to Assess the Safety and Performance of Two Prototype One Piece Pouches in Subjects With an Ileostomy
- ClinicalTrials.gov ID
- NCT01782196
- Acronym / sponsor ID
- U366 / CC-0512-12-U366
- Conditions
- Ileostomy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Leakage
- Enrolment
- 13 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Feb 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Certain research and innovation projects require an assessment of the adhesive properties of adhesives, which cannot be established from in-vitro testing. The most valuable data for assessments of this type comes from adhesion and wear time studies involving application to living human skin on volunteers. The purpose of the study is to assess the safety and performance of an enhanced one piece drainable pouch with a mouldable skin barrier wafer in a group of subjects with an ileostomy.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Type A Pouch followed by Type B pouch | Experimental | Device: Enhanced one piece drainable pouch with Type A mouldable adhesive, Device: Enhanced one piece drainable pouch with Type B mouldable adhesiveEnhanced one piece drainable pouch with Type A mouldable adhesive for Stage 1 and 2 followed by pouch with Type B mouldable adhesive for Stage 3 |
| Type B Pouch followed by Type A pouch | Experimental | Device: Enhanced one piece drainable pouch with Type A mouldable adhesive, Device: Enhanced one piece drainable pouch with Type B mouldable adhesiveEnhanced one piece drainable pouch with Type B mouldable adhesive for Stage 1 and 2 followed by pouch with Type A mouldable adhesive for Stage 3 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Subjects who provide written informed consent.
- Subjects who have an ileostomy and be over 18 years of age.
- Subjects who are currently using a one piece drainable pouch.
- Subjects who have unbroken peri-stomal skin (healthy normal skin defined as "normal unbroken skin with certain variations normal for this subject" to L1 on the SACs Instrument Scale).
- Subjects with a stoma considered 'normal' in appearance in accordance with the stoma, colour, moisture and structure rating scales.
Key exclusion criteria (7 listed)
- Subjects with a history of sensitivity to any one of the ostomy products or the components being studied.
- Subjects with stoma duration of less than 3 months.
- Subjects who currently use a belt with their usual appliance.
- Subjects who have been entered into the study before, or who have previously taken part in a study in the last month.
- Subjects who require convexity or other skin fillers (pastes, rings, seals) to even undulations of the skin.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Enhanced one piece drainable pouch with Type A mouldable adhesive | Device | Type A Pouch followed by Type B pouch, Type B Pouch followed by Type A pouch |
| Enhanced one piece drainable pouch with Type B mouldable adhesive | Device | Type A Pouch followed by Type B pouch, Type B Pouch followed by Type A pouch |
Primary outcome
Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions
Time frame: 59 days
The primary objective of this study is to evaluate the safety of the enhanced one piece drainable pouch with a mouldable skin barrier wafer and two alternate adhesives in subjects with an ileostomy.
1 secondary outcome
Performance
Time frame: 59 days
Results and safety
The study was stopped early (reason given: Leakage). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Enhanced one piece drainable pouch with Type A mouldable adhesive and Enhanced one piece drainable pouch with Type B mouldable adhesive in people with Ileostomy, run by ConvaTec Inc. at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 3 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Leakage). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety - evaluated by the nature and frequency of adverse events including stomal and peristomal skin condition and lesions (time frame: 59 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2013.