StomaPhase 4NCT00626821
Coloplast DialogueStudy
A Phase 4 study testing SenSura in people with Stoma, run by Coloplast A/S at 1 site in United States.
Trial summary
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stoma
- What is being tested?
- SenSura
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,017 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Dec 2010
- Phase
- Phase 4
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent before any study related activities
- Subjects with a colostomy, ileostomy or urostomy
- Subjects must have had their ostomy for at least 6 months
- Subjects must have mental capacity to understand the study and questionnaires
- Subjects must be at least 18 years of age.
Who cannot join
- Women who are pregnant or breast-feeding
- Subjects who have more than one ostomy
- Subjects with an ostomy who use plug
- Participation in other studies at the same time
- Previous participation in this study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
Read the detailed description
It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.
- Conditions
- Stoma
- Being tested
- SenSura
- Keywords
- Stoma, Ostomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SenSuraDevice
Real life assessment of SenSura
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Device: SenSura |
What is being measured
The primary outcome is the main question the study is designed to answer.
Quality of Life (Scale 0(Worst)-100(Best))
The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.
Measured: 6-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2008 (estimated)
- Study startFeb 2008
- Primary completionApr 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 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 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3,017 participants (actual)
Sponsor and investigators
- Lead sponsor
- Coloplast A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Birgitte D Andersen, RN, Principal investigator, Herlev Hospital, Dep of colorectal surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00626821
- Sponsor's protocol ID
- DK175OS
- Status last verified
- Jan 2012
- First submitted
- 21 Feb 2008
- Last updated
- 12 Mar 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open Label, Non-comparative, Multi-national Post-Market Study to Document Real Life Experience on SenSura With Focus on Skin Condition and Quality of Life
- ClinicalTrials.gov ID
- NCT00626821
- Acronym / sponsor ID
- DK175OS
- Conditions
- Stoma
- Keywords
- Stoma, Ostomy
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3,017 participants (actual)
- Lead sponsor
- Coloplast A/SIndustry (pharma, biotech, devices)
- Study start
- Feb 2008
- Primary completion
- Apr 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 29 Feb 2008 (estimated)
- Results
- Posted 12 Mar 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main purpose of the study is to document real life experience on SenSura with focus on skin condition and quality of life.
Detailed description
It is important to continuously develop and test ostomy products in order to prevent peristomal skin disorders and to enhance the quality of life for people with a stoma. Furthermore, it is essential to create awareness about the importance of healthy peristomal skin as many of these conditions are preventable.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Device: SenSura |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Signed informed consent before any study related activities
- Subjects with a colostomy, ileostomy or urostomy
- Subjects must have had their ostomy for at least 6 months
- Subjects must have mental capacity to understand the study and questionnaires
- Subjects must be at least 18 years of age.
Key exclusion criteria (5 listed)
- Women who are pregnant or breast-feeding
- Subjects who have more than one ostomy
- Subjects with an ostomy who use plug
- Participation in other studies at the same time
- Previous participation in this study
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 |
|---|---|---|
| SenSuraReal life assessment of SenSura | Device | 1 |
Primary outcome
Quality of Life (Scale 0(Worst)-100(Best))
Time frame: 6-8 weeks
The mean change in quality of life (Stoma-QoL value) from visit 1 to visit 2. An increase in Stoma-QoL is an improvement, a decrease in Stoma-QoL is a worsening.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Stoma
Active, not recruiting
The Effect of Planned Group Interaction on Ostomy Adaptation, Quality of Life, and Stoma Care Self-Efficacy Levels in Individuals With an Ostomy
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Novel Post-Surgical Incision Management to Prevent Ostomy Complications
Ostomy, Enterocutaneous Fistula
Active, not recruiting
ColoSeal™ ICD System Anastomotic Protection Pivotal Study
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Exploratory Study of Peristomal and Non-Peristomal Skin Barrier Characteristics in People With a Stoma
Colostomy - Stoma, Ileostomy - Stoma
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Frailty, Quality Of Life and Early Reversal of Temporary Defunctioning Stoma in Ovarian Cancer
Ovarian Cancer
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.
Birgitte D Andersen, RN principal investigator
Herlev Hospital, Dep of colorectal surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing SenSura in people with Stoma, run by Coloplast A/S at 1 site in United States.
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 5 inclusion and 5 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 12 Mar 2012. 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 United States. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2012). 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?
Quality of Life (Scale 0(Worst)-100(Best)) (time frame: 6-8 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 12 Mar 2012.