OstomyNCT01691729
Comparison Study of 3 Ostomy Products
A study testing Ostomy accessory in people with Ostomy, run by ConvaTec Inc. at 4 sites in United States.
Trial summary
To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ostomy
- What is being tested?
- Ostomy accessory
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 4 sitesUnited States
- Study dates
- Sep 2012to Nov 2012
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Has an ostomy
- Is at least 18 years of age
- Has a stoma for at least 3 months
- Other than thier ostomy is considered to have a healthy/stable health
- Is able to take care of their stoma
Who cannot join
- Known sensitivity to any of the ostomy devices or components
- Is undergoing chemotherapy or radiotherapy
- Has participated in a clinical study within the past 30 days
- Has a medical condition, in which in the opinion of the Investigator would not be a good candidate for the study and justifies exclusion
Trial locations and contacts
4 sites in 1 country.
United States4 sites
ID MED Inc.
Columbus, Ohio, 43222
ET Nursing Services
Jacksonville, Florida, 32257
Image Specialties
Saint Joseph, Missouri, 64506
Independent Nurse Consultants
Tucson, Arizona, 85742
About this study
Official title: A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products
To purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.
Read the detailed description
The primary objective of this study was to evaluate and compare the efficacy of three ostomy accessory products in terms of leakage and wear time. Secondary objectives were to evaluate and compare the safety of three ostomy accessory products, and to assess and compare the performance of the three products in terms of use and overall impression.
- Conditions
- Ostomy
- Being tested
- Ostomy accessory
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ostomy accessoryDevice
Wearing each of the devices for 10 days each
| Study group | Role | What they receive |
|---|---|---|
| Ostomy 1 | Other | 3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2 Receives: Device: Ostomy accessory |
| Ostomy 2 | Other | 3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1 Receives: Device: Ostomy accessory |
| Ostomy 3 | Other | 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product Receives: Device: Ostomy accessory |
| Ostomy 4 | Other | 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product Receives: Device: Ostomy accessory |
| Ostomy 5 | Other | 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2 Receives: Device: Ostomy accessory |
| Ostomy 6 | Other | 3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1 Receives: Device: Ostomy accessory |
What is being measured
The primary outcome is the main question the study is designed to answer.
Leakage & Wear Time
Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.
Measured: 10 days
Secondary outcomes (1)
Number of adverse events
Evaluation and comparison of the safety of three ostomy accessory products
Measured: 10 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionNov 2012
- Study completionNov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for OstomyStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kim Peters, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01691729
- Sponsor's protocol ID
- A739
- Status last verified
- Dec 2022
- First submitted
- 12 Sep 2012
- Last updated
- 7 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Multicenter, Cross-Over Study Comparing the Performance of Three Ostomy Accessory Products
- ClinicalTrials.gov ID
- NCT01691729
- Acronym / sponsor ID
- A739
- Conditions
- Ostomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Sep 2012 (actual)
- Primary completion
- Nov 2012 (actual)
- Study completion
- Nov 2012 (actual)
- First posted
- 25 Sep 2012 (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 purpose of the study is to evaluate and compare the efficacy of three ostomy accessory products.
Detailed description
The primary objective of this study was to evaluate and compare the efficacy of three ostomy accessory products in terms of leakage and wear time. Secondary objectives were to evaluate and compare the safety of three ostomy accessory products, and to assess and compare the performance of the three products in terms of use and overall impression.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Ostomy 1 | Other | Device: Ostomy accessory3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy AccessoryProduct/Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2 |
| Ostomy 2 | Other | Device: Ostomy accessory3 Ostomy Accessory Devices with the order of wear being Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1 |
| Ostomy 3 | Other | Device: Ostomy accessory3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product |
| Ostomy 4 | Other | Device: Ostomy accessory3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product |
| Ostomy 5 | Other | Device: Ostomy accessory3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #1/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #2 |
| Ostomy 6 | Other | Device: Ostomy accessory3 Ostomy Accessory Devices with the order of wear being Ostomy Accessory Marketed Product #2/Investigative Ostomy Accessory Product/Ostomy Accessory Marketed Product #1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Has an ostomy
- Is at least 18 years of age
- Has a stoma for at least 3 months
- Other than thier ostomy is considered to have a healthy/stable health
- Is able to take care of their stoma
Key exclusion criteria (4 listed)
- Known sensitivity to any of the ostomy devices or components
- Is undergoing chemotherapy or radiotherapy
- Has participated in a clinical study within the past 30 days
- Has a medical condition, in which in the opinion of the Investigator would not be a good candidate for the study and justifies exclusion
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 |
|---|---|---|
| Ostomy accessoryWearing each of the devices for 10 days each | Device | Ostomy 1, Ostomy 2, Ostomy 3, Ostomy 4, Ostomy 5, Ostomy 6 |
Primary outcome
Leakage & Wear Time
Time frame: 10 days
Evaluation and comparison of the efficacy of three ostomy accessory products in terms of leakage and wear time.
1 secondary outcome
Number of adverse events
Time frame: 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 7 Dec 2022.
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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.
Kim Peters study director
ConvaTec Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ostomy accessory in people with Ostomy, run by ConvaTec Inc. at 4 sites 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 4 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 7 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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.
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?
Leakage & Wear Time (time frame: 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 7 Dec 2022; AzTrials last refreshed its copy on 31 Oct 2026.