OstomyPhase 1NCT01261988
Assess the Safety and Adhesive Performance of the VIPER System When Compared to Esteem™
A Phase 1 study testing VIPER and Esteem™ Cut to Fit One Piece Closed End Pouch in people with Ostomy, run by ConvaTec Inc. at 1 site in United States.
Trial summary
The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Ostomy
- What is being tested?
- VIPER and Esteem™ Cut to Fit One Piece Closed End Pouch
- Type of treatment
- Medical device
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to Dec 2010
- Phase
- Phase 1
- 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 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 and 70 years of age (inclusive) at the time of randomization
- Willing and able to provide written informed consent and HIPAA Waiver
- An appropriate candidate for participation with unbroken non-irritated abdominal skin
- Willing to adhere to the study procedures and to attend the scheduled study visits according to the requirements of the study protocol
- Willing to adhere to the scheduled study visits
- Good manual dexterity and be able to take care of their abdominal area independently
- Be willing and able to record the required study data in a specified format
Who cannot join
- A history of a known sensitivity or allergy to System 3+ adhesive (modified Stomahesive® technology), Stomahesive®, Durahesive®, Polyethylene Film, or polyester fiber,or to any adhesive components in general as listed in the Investigators Brochure.
- Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
- Subjects with any chronic allergies requiring the use of prescription medication
- History of skin disease affecting abdominal area
- Currently uses topical ointments in the area of the abdomen or is unwilling/unable to terminate over the counter use of topical ointments in the area of the abdomen
- Active case of eczema, dermatitis, psoriasis
Show all 9Show fewer
- Pregnant or lactating females.
- Subject currently enrolled in another investigational study
- Possesses extensive knowledge about either product (ie employees that re members or extended members of the Core Team work in ostomy research and development, or ostomy division sales and marketing )
Trial locations and contacts
1 site in 1 country.
United States1 site
Susan Bell, RN, MSN, CWOCN
Jobstown, New Jersey, 08041
About this study
Official title: A Single Center, Feasibility Study Using Healthy Volunteers to Assess the Safety and Adhesive Performance of the VIPER System When Compared to the Esteem™ Cut to Fit One Piece Closed End Pouch
The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
- Conditions
- Ostomy
- Being tested
- VIPER, Esteem™ Cut to Fit One Piece Closed End Pouch
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VIPERDevice
Comparison of ostomy systems
Esteem™ Cut to Fit One Piece Closed End PouchDevice
Comparison of ostomy systems
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety: Related Events
All adverse events (AE's) related to the use of the device
Measured: 17 hours
Efficacy: Device Fall-Offs
The number and percentage of subjects with study device fall-off during the study
Measured: 17 hours
Efficacy: Device Fall-Offs
The total number of study device fall-offs during the course of the study
Measured: 17 hours
Safety: Skin Reactions
Measured: 17 hours
Secondary outcomes (3)
Adhesive
Initial tack of the adhesive (during first hour of wear)
Measured: 1 hour
Ease of Removal
Ease of removal of the adhesive wafer from the skin
Measured: 17 hours
Security
Perceived security of the study pouch during wear
Measured: 17 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ConvaTec Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Qing Li, PhD, Study director, ConvaTec Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01261988
- Sponsor's protocol ID
- CC-0512-10-A723
- Status last verified
- Dec 2010
- First submitted
- 15 Dec 2010
- Last updated
- 20 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single Center, Feasibility Study Using Healthy Volunteers to Assess the Safety and Adhesive Performance of the VIPER System When Compared to the Esteem™ Cut to Fit One Piece Closed End Pouch
- ClinicalTrials.gov ID
- NCT01261988
- Acronym / sponsor ID
- CC-0512-10-A723
- Conditions
- Ostomy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- ConvaTec Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2010
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 17 Dec 2010 (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.
The primary objective of the study is to assess the safety and adhesive performance of the VIPER System when compared to the Esteem™ Cut to Fit One Piece Closed End Pouch when used by healthy volunteers.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Male or female between 18 and 70 years of age (inclusive) at the time of randomization
- Willing and able to provide written informed consent and HIPAA Waiver
- An appropriate candidate for participation with unbroken non-irritated abdominal skin
- Willing to adhere to the study procedures and to attend the scheduled study visits according to the requirements of the study protocol
- Willing to adhere to the scheduled study visits
Key exclusion criteria (9 listed)
- A history of a known sensitivity or allergy to System 3+ adhesive (modified Stomahesive® technology), Stomahesive®, Durahesive®, Polyethylene Film, or polyester fiber,or to any adhesive components in general as listed in the Investigators Brochure.
- Subjects who have any other medical condition which, according to the investigator justifies exclusion from the study
- Subjects with any chronic allergies requiring the use of prescription medication
- History of skin disease affecting abdominal area
- Currently uses topical ointments in the area of the abdomen or is unwilling/unable to terminate over the counter use of topical ointments in the area of the abdomen
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 |
|---|---|---|
| VIPERComparison of ostomy systems | Device | – |
| Esteem™ Cut to Fit One Piece Closed End PouchComparison of ostomy systems | Device | – |
Primary outcome
Safety: Related Events
Time frame: 17 hours
All adverse events (AE's) related to the use of the device
Efficacy: Device Fall-Offs
Time frame: 17 hours
The number and percentage of subjects with study device fall-off during the study
Efficacy: Device Fall-Offs
Time frame: 17 hours
The total number of study device fall-offs during the course of the study
Safety: Skin Reactions
Time frame: 17 hours
3 secondary outcomes
Adhesive
Time frame: 1 hour
Ease of Removal
Time frame: 17 hours
Security
Time frame: 17 hours
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 20 Dec 2010.
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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.
Qing Li, PhD study director
ConvaTec Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing VIPER and Esteem™ Cut to Fit One Piece Closed End Pouch in people with Ostomy, 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 7 inclusion and 9 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 20 Dec 2010. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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: Related Events (time frame: 17 hours). The study lists 4 primary outcomes in all. 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 20 Dec 2010.