Stoma IleostomyCP257NCT02887144
Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy
A study testing SenSura and SenSura test product in people with Stoma Ileostomy, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma Ileostomy
- What is being tested?
- SenSura and SenSura test product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2016to Aug 2016
- 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
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Be able to handle the products themselves
- Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm
- Have had their ileostomy for at least 3 months
- Have used a 1-piece flat or convex light ostomy appliance with an open bag within the last month
Show all 10Show fewer
- Currently using midi or maxi bags
- Willing to use minimum 1 product every second day (max. 2 days wear time)
- Be mentally and physically capable of understanding and following the study procedures and completing the Case Report Form
- Must be able to cut products themselves
Who cannot join
- Currently receiving or have received within the past 2 months chemo- or/and radiation therapy
- Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Currently suffering from peristomal skin problems (i.e. bleeding or broken skin).
- Known hypersensitivity of the product components and/or ingredients
Trial locations and contacts
1 site in 1 country.
About this study
The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.
Read the detailed description
Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.
- Conditions
- Stoma Ileostomy
- Being tested
- SenSura, SenSura test product
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSuraDevice
SenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S
SenSura test productDevice
SenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S
| Study group | Role | What they receive |
|---|---|---|
| SenSura test product 1pc | Experimental | Subjects randomized to treatment sequence 1test:
1. SenSura test product
2. SenSura Receives: Device: SenSura; Device: SenSura test product |
| SenSura 1pc | Experimental | Subjects randomized to treatment sequence 2 test:
1. SenSura
2. SunSura test product Receives: Device: SenSura; Device: SenSura test product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of leakage
Leakage under and outside the baseplate will be assessed by a 4 point leakage scale.
Measured: patients will test the products for 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2016 (estimated)
- Study startJan 2016
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stoma 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02887144
- Sponsor's protocol ID
- Coloplast - CP257
- Acronym
- CP257
- Status last verified
- Aug 2016
- First submitted
- 17 Dec 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Performance of SenSura Test Product in Subjects With Ileostomy
- ClinicalTrials.gov ID
- NCT02887144
- Acronym / sponsor ID
- CP257 / Coloplast - CP257
- Conditions
- Stoma Ileostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Jan 2016
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 2 Sep 2016 (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.
The aim of the current Investigation is to evaluate the safety and performance of SenSura test product 1pc flat and convex light compared with commercial SenSura.
Detailed description
Investigators want to measure degree of leakage on a 4-point scale of SenSura and SenSura test product.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SenSura test product 1pc | Experimental | Device: SenSura, Device: SenSura test productSubjects randomized to treatment sequence 1test: 1. SenSura test product 2. SenSura |
| SenSura 1pc | Experimental | Device: SenSura, Device: SenSura test productSubjects randomized to treatment sequence 2 test: 1. SenSura 2. SunSura test product |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Have given written informed consent
- Be at least 18 years of age and have full legal capacity
- Be able to handle the products themselves
- Have an ileostomy (end or loop ostomy) with a diameter between 10 - 40 mm
- Have had their ileostomy for at least 3 months
Key exclusion criteria (6 listed)
- Currently receiving or have received within the past 2 months chemo- or/and radiation therapy
- Currently receiving or have received within the past month local or systemic steroid treatment in the peristomal area
- Are pregnant or breastfeeding
- Participating in other interventional clinical investigations or have previously participated in this investigation
- Currently suffering from peristomal skin problems (i.e. bleeding or broken 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 |
|---|---|---|
| SenSuraSenSura is a Commercial and CE-marked ostomy product (1pc) manufactured by Coloplast A/S | Device | SenSura 1pc, SenSura test product 1pc |
| SenSura test productSenSura test product is a CE-marked ostomy product (1pc) manufactured by Coloplast A/S | Device | SenSura 1pc, SenSura test product 1pc |
Primary outcome
Degree of leakage
Time frame: patients will test the products for 4 weeks
Leakage under and outside the baseplate will be assessed by a 4 point leakage scale.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SenSura and SenSura test product in people with Stoma Ileostomy, run by Coloplast A/S at 1 site in Denmark.
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 6 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: finished, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Degree of leakage (time frame: patients will test the products for 4 weeks). 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 2 Sep 2016.