IleostomyPhase 2NCT01939106
One Piece Drainable Pouch in Subjects With an Ileostomy
A Phase 2 study testing One Piece Drainable Pouch in people with Ileostomy, run by ConvaTec Inc. at 1 site in United States.
Trial summary
To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ileostomy
- What is being tested?
- One Piece Drainable Pouch
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to Jun 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 an ileostomy for more than 3 months
- Currently a one or two piece 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 20Show fewer
- Be willing to wear a one piece drainable 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 ileostomy 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
- Exclusion Criteria - The following subjects must not be included into the study:
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Independent Nurse Consultant LLC
Tucson, Arizona, 85742
About this study
Official title: A Single Center Study to Assess the Safety and Performance of a One Piece Drainable Pouch in Subjects With an Ileostomy
To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
Read the detailed description
This is a pre market study to assess safety and performance of a one piece drainable pouch. Twelve subjects will be recruited and will use the study pouch for 10 days. During this time data on skin and stoma condition will be collected along with questions related to ease of use comfort and overall pouch performance. The study will be conducted in the US in one single site.
- Conditions
- Ileostomy
- Being tested
- One Piece Drainable Pouch
- Keywords
- Stoma, Ileostomy, pouch, Drainable Pouch for collection of stool
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Piece Drainable PouchDevice
Also called Enhanced one piece drainable pouch
| Study group | Role | What they receive |
|---|---|---|
| One Piece Drainable Pouch | Other | This is a one piece drainable pouch designed for the purpose of collecting stool from subjects with an ileostomy stoma Receives: Device: One Piece Drainable Pouch |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
To assess the condition of the peristomal skin and stoma and number and frequency of adverse events
Measured: Study duration will be 10 days
Secondary outcomes (1)
Performance/Efficacy
To assess ease of use including ease of application and removal, comfort and security along with wear time
Measured: The study will be for 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2013 (estimated)
- Study startJun 2013
- Primary completionJun 2013
- Study completionJun 2013
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 2
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ann Popavich-Durnal, RN BSN, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01939106
- Sponsor's protocol ID
- CC-0512-13-A740
- Status last verified
- Sep 2013
- First submitted
- 29 Jul 2013
- Last updated
- 11 Sep 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 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 Drainable Pouch in Subjects With an Ileostomy
- ClinicalTrials.gov ID
- NCT01939106
- Acronym / sponsor ID
- CC-0512-13-A740
- Conditions
- Ileostomy
- Keywords
- Stoma, Ileostomy, pouch, Drainable Pouch for collection of stool
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 11 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.
To assess the safety and performance of an enhanced one piece drainable pouch in subjects with an ileostomy.
Detailed description
This is a pre market study to assess safety and performance of a one piece drainable pouch. Twelve subjects will be recruited and will use the study pouch for 10 days. During this time data on skin and stoma condition will be collected along with questions related to ease of use comfort and overall pouch performance. The study will be conducted in the US in one single site.
Study design
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| One Piece Drainable Pouch | Other | Device: One Piece Drainable PouchThis is a one piece drainable pouch designed for the purpose of collecting stool from subjects with an ileostomy stoma |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 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 an ileostomy for more than 3 months
- Currently a one or two piece 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 (0 listed)
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 Drainable PouchAlso: Enhanced one piece drainable pouch | Device | One Piece Drainable Pouch |
Primary outcome
Safety
Time frame: Study duration will be 10 days
To assess the condition of the peristomal skin and stoma and number and frequency of adverse events
1 secondary outcome
Performance/Efficacy
Time frame: The study will be for 10 days
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 11 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 Popavich-Durnal, RN BSN principal investigator
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 Drainable Pouch in people with Ileostomy, 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 20 inclusion and 0 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 11 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: Study duration will be 10 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 11 Sep 2013.