Ileostomy - StomaNCT01103466
Investigation of the Performance of Ostomy Base Plate
A study testing Atlas, SenSura and Conform 2 in people with Ileostomy - Stoma, run by Coloplast A/S at 1 site in Denmark.
Trial summary
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ileostomy - Stoma
- What is being tested?
- Atlas, SenSura and Conform 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteDenmark
- Study dates
- Apr 2010to Dec 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Have given written Informed Consent
- Are at least 18 years old
- Had their ileostomy for minimum 3 months with a size between 20-40 mm
- Have mental capacity to understand study guidelines and questionnaires
- Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.
- Experience leakage under the base plate at least one a week
Show all 9Show fewer
- Are currently using a flat 2-piece base plate with mechanical coupling
- Have been evaluated by investigator (i.e. a health care professional) to have a stoma and peristomal skin condition that is acceptable for entering the study
- -
Who cannot join
- Pregnant or breast-feeding
- Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently using steroid product on peristomal skin (injections and oral treatment are accepted)
- Currently using a convex system
- Participating in other clinical studies or have previously participated in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomised Controlled Cross-over Study Investigating the Performance and Safety of the Ostomy Base Plate SSH
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.
Read the detailed description
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new base plate (SSH) to improve security and increase comfort by minimizing leakage (seeping under the base plate) risk and thereby also the leakage related peristomal skin problems.
The purpose with this clinical study is to evaluate the effect of the new base plate on the degree of leakage under the base plate compared to two existing base plates on the market.
The study is a randomised controlled cross-over intervention study, where all study participants will test all three test products (SSH, Conform 2 and Sensura). Each test period will last 14 days. If 4 changes of base plates is not obtained during the 14 days, the test period will be prolonged until 4 base plate changes is obtained. However, the max test period of one type of product is 21 days. The participants will visit the study investigator at study start and at every shift to a new type of test product. At these visits they will answer questions about the tested product, have a peristomal skin examination and be instructed in how to use the next test products for the next treatment period. Evaluation of leakage and handling will occur via questionnaires the participants take home.
80 healthy participants with an ileostomy will be included in the study.
- Conditions
- Ileostomy - Stoma
- Being tested
- Atlas, SenSura, Conform 2
- Keywords
- Ileostomy base plate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AtlasDevice
Also called ostomy appliance
Altas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
SenSuraDevice
Also called ostomy appliance
SenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
Conform 2Device
Also called Ostomy appliance
Conform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates.
| Study group | Role | What they receive |
|---|---|---|
| New ostomy appliance (Atlas) | Active comparator | Atlas= new base plate. Due to company confidentiality the product is just called Atlas and this is not short for any other names Receives: Device: Atlas |
| SenSura | Active comparator | Commercially available ostomy appliance Receives: Device: SenSura |
| Conform 2 | Active comparator | Commercially available ostomy appliance Receives: Device: Conform 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage Under the Base Plate
Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.
Measured: At every change of base plate
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2010 (estimated)
- Study startApr 2010
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Ileostomy - StomaStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lis H Poulsen, MD, Principal investigator, Coloplast A/S
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01103466
- Sponsor's protocol ID
- CP204OC
- Status last verified
- Feb 2013
- First submitted
- 13 Apr 2010
- Last updated
- 4 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Cross-over Study Investigating the Performance and Safety of the Ostomy Base Plate SSH
- ClinicalTrials.gov ID
- NCT01103466
- Acronym / sponsor ID
- CP204OC
- Conditions
- Ileostomy - Stoma
- Keywords
- Ileostomy base plate
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Apr 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 14 Apr 2010 (estimated)
- Results
- Posted 4 Apr 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the performance of Atlas (new base plate) on the degree of leakage under the base plate compared to SenSura and Conform 2. Our hypothesis is that Atlas will do better than the two comparator products.
Detailed description
Peristomal skin problems are reported to have a negative impact on the quality of life of people with a stoma and cause one third of all visits to a stoma care nurse. Stoma effluent in contact with the peristomal skin (leakage) appears to predispose patients to peristomal skin problems. To protect the skin against effluent, the appliance used for collection of stoma effluent should completely cover the peristomal skin close to the stoma. Coloplast has developed a new base plate (SSH) to improve security and increase comfort by minimizing leakage (seeping under the base plate) risk and thereby also the leakage related peristomal skin problems.
The purpose with this clinical study is to evaluate the effect of the new base plate on the degree of leakage under the base plate compared to two existing base plates on the market.
The study is a randomised controlled cross-over intervention study, where all study participants will test all three test products (SSH, Conform 2 and Sensura). Each test period will last 14 days. If 4 changes of base plates is not obtained during the 14 days, the test period will be prolonged until 4 base plate changes is obtained. However, the max test period of one type of product is 21 days. The participants will visit the study investigator at study start and at every shift to a new type of test product. At these visits they will answer questions about the tested product, have a peristomal skin examination and be instructed in how to use the next test products for the next treatment period. Evaluation of leakage and handling will occur via questionnaires the participants take home.
80 healthy participants with an ileostomy will be included in the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| New ostomy appliance (Atlas) | Active comparator | Device: AtlasAtlas= new base plate. Due to company confidentiality the product is just called Atlas and this is not short for any other names |
| SenSura | Active comparator | Device: SenSuraCommercially available ostomy appliance |
| Conform 2 | Active comparator | Device: Conform 2Commercially available ostomy appliance |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Have given written Informed Consent
- Are at least 18 years old
- Had their ileostomy for minimum 3 months with a size between 20-40 mm
- Have mental capacity to understand study guidelines and questionnaires
- Are capable to changing base plate and pouches without help. The help of a caregiver is accepted.
Key exclusion criteria (6 listed)
- Pregnant or breast-feeding
- Currently suffering from peristomal skin problems where the skin is damaged or bleeding (red and broken / broken and bleeding) as clinically evaluated by the investigator.
- Currently receiving or have within the past 2 months received radio- and/or chemotherapy
- Currently using steroid product on peristomal skin (injections and oral treatment are accepted)
- Currently using a convex system
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 |
|---|---|---|
| AtlasAlso: ostomy applianceAltas base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates. | Device | New ostomy appliance (Atlas) |
| SenSuraAlso: ostomy applianceSenSura base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates. | Device | SenSura |
| Conform 2Also: Ostomy applianceConform 2 base plates are tested for 14 days (minimum 4 base plates) and the degree of leakage under the baseplate is measured and compared to two other types of base plates. | Device | Conform 2 |
Primary outcome
Leakage Under the Base Plate
Time frame: At every change of base plate
Area of leakage under the base plate is recorded on a circular scale going from 0 fields to 24 fields where 0 is "no leakage" and 24 is "complete leakage" under the base plate.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Lis H Poulsen, MD principal investigator
Coloplast A/S
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Atlas, SenSura and Conform 2 in people with Ileostomy - Stoma, 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 9 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 4 Apr 2013. 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?
Yes. Results are posted in the registry (first posted 4 Apr 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Leakage Under the Base Plate (time frame: At every change of base plate). 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 4 Apr 2013.