User Evaluation of the Peristomal Skin Condition in Ostomates Using ConvaTec Moldable Technology™
NCT ID: NCT02499588
Last Updated: 2015-07-16
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
600 participants
OBSERVATIONAL
2015-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Interventions
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Esteem Plus with ConvaTec Moldable Technology
Natura with ConvaTec Moldable Technology
Natura Accordion with ConvaTec Moldable Technology
Esteem synergy Plus with ConvaTec Moldable Technology
Eligibility Criteria
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Inclusion Criteria
* Subjects who agree to participate in the evaluation and who have signed the informed consent form.
* Subjects presenting with a stoma (ileostomy, colostomy or urostomy).
* Subjects for whom ConvaTec Moldable Technology™ per package insert, within the context of routine clinical care is used as the first long-term (within 7 days of ostomy surgery) system following surgery and who have intact peristomal skin (healthy or SACs L1).
Exclusion Criteria
* Subjects who are in a simultaneous clinical evaluation.
18 Years
ALL
No
Sponsors
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ConvaTec Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Kim Peters, BSc (Hons)
Role: STUDY_DIRECTOR
Sponsor GmbH
Locations
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Voivodeship Specialistic Hospital in Gorzow Wlkp.
Gorzów Wielkopolski, Lubusz Voivodeship, Poland
Countries
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Central Contacts
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Facility Contacts
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Mariola Mikołajczak
Role: primary
Other Identifiers
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CC-0509-15-U375
Identifier Type: -
Identifier Source: org_study_id
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