ColostomyPhase 2NCT01935999
One Piece Closed Pouch in Subjects With a Colostomy
A Phase 2 study testing One piece closed pouch in people with Colostomy, run by ConvaTec Inc. at 1 site in United States.
Trial summary
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Colostomy
- What is being tested?
- One piece closed pouch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jul 2013
- Phase
- Phase 2
- 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
- Of legal consenting age and able to provide written informed consent
- Is able to read, write, and understand the primary language of the investigative site.
- Have a colostomy for more than 3 months
- Currently a one or two piece closed or drainable pouch user (all attempts will be made to include ConvaTec Active Life or Esteem Plus one piece closed pouch users)
- Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
- Have a stoma considered 'normal' in appearance in accordance with the stoma, color, moisture and structure rating scales
Show all 15Show fewer
- Be willing to wear a one piece closed pouch with moldable wafer according to the usual wear pattern of this type of pouch
- Be willing to participate in the trial for 10 days plus 1 visit prior to the in-residence study period.
- Be willing to remain in residence for 3 days at a central location
- Be willing to meet with the investigator for a total of nine scheduled visits.
- Be 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
- Other than their colostomy considered to have a healthy/stable health status
- Have good manual dexterity and be able to take care of their stoma independently
- Be willing and able to complete a diary card for the duration of the study.
- Be willing to take photographs of the stoma and pouch on pouch removal
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, seals, or rings) to even undulations of the peristomal 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
1 site in 1 country.
United States1 site
Independent Nurse Consultants LLC
Tucson, Arizona, 85742
About this study
Official title: A Single Center Study to Assess the Safety and Performance of a One Piece Closed Pouch in Subjects With a Colostomy
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
Read the detailed description
Twelve subjects are to be recruited into this 10 day single centre study to assess primarily safety in terms of adverse events and condition of the skin surrounding the stoma and condition of the stoma. Performance will also be assessed.
- Conditions
- Colostomy
- Being tested
- One piece closed pouch
- Keywords
- Colostomy, peristomal skin, stoma, pouch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One piece closed pouchDevice
Also called Enhanced one piece closed pouch
A one piece closed pouch for the collection of stool from a colostomy stoma
| Study group | Role | What they receive |
|---|---|---|
| One piece closed pouch | Other | One piece closed pouch Receives: Device: One piece closed pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
Safety in relation to type and number of adverse events, condition of the skin surrounding the colostomy stoma and condition of the stoma
Measured: 10 days - duration of study period
Secondary outcomes (1)
Performance/Efficacy
Performance/Efficacy of the pouch to stay in place and collect stool from the stoma. Ease of use, security will be assessed
Measured: 10 days duration of study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ColostomyStudies 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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Popovich-Durnal, RN BSN, Principal investigator, Unafilliated
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01935999
- Sponsor's protocol ID
- CC-0512-13-A741
- Status last verified
- Sep 2013
- First submitted
- 29 Jul 2013
- Last updated
- 6 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center Study to Assess the Safety and Performance of a One Piece Closed Pouch in Subjects With a Colostomy
- ClinicalTrials.gov ID
- NCT01935999
- Acronym / sponsor ID
- CC-0512-13-A741
- Conditions
- Colostomy
- Keywords
- Colostomy, peristomal skin, stoma, pouch
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 5 Sep 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.
A study to assess the safety and performance of an enhanced one piece closed pouch in a 12 subjects with a colostomy.
Detailed description
Twelve subjects are to be recruited into this 10 day single centre study to assess primarily safety in terms of adverse events and condition of the skin surrounding the stoma and condition of the stoma. Performance will also be assessed.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One piece closed pouch | Other | Device: One piece closed pouchOne piece closed pouch |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (15 listed)
- Of legal consenting age and able to provide written informed consent
- Is able to read, write, and understand the primary language of the investigative site.
- Have a colostomy for more than 3 months
- Currently a one or two piece closed or drainable pouch user (all attempts will be made to include ConvaTec Active Life or Esteem Plus one piece closed pouch users)
- Have unbroken peri-stomal skin (healthy normal skin to L1 on the SACs Instrument Scale # 1)
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, seals, or rings) to even undulations of the peristomal 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 |
|---|---|---|
| One piece closed pouchAlso: Enhanced one piece closed pouchA one piece closed pouch for the collection of stool from a colostomy stoma | Device | One piece closed pouch |
Primary outcome
Safety
Time frame: 10 days - duration of study period
Safety in relation to type and number of adverse events, condition of the skin surrounding the colostomy stoma and condition of the stoma
1 secondary outcome
Performance/Efficacy
Time frame: 10 days duration of study period
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 6 Sep 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.
Ann Popovich-Durnal, RN BSN principal investigator
Unafilliated
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing One piece closed pouch in people with Colostomy, run by ConvaTec Inc. 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 15 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: finished, as of the sponsor's last update on 6 Sep 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 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Safety (time frame: 10 days - duration of study period). 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 6 Sep 2013.