Trials / Completed
CompletedNCT01706861
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid Lesions Treated Adjunctive to Surgical Excision
A Post Market Study Evaluating the Safety, Device Perfomance and Possible Emergent Risks of Celotres in Preventing Recurrence in Keloid LEsions Treated Adjunctive to suRgical Excision. PMCS: EURO-KLEAR
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 51 (actual)
- Sponsor
- Halscion, Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
The objective of the study is to actively gather additional information on safety, device performance and possible emergent risks following the use of Celotres in a post-market setting when used to reduce the recurrence rate, volume, appearance and/or symptoms associated with keloid scarring in subjects undergoing surgical excision of keloids as compared to the scientific literature.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | Celotres | Celotres following surgical removal of earlobe keloid. |
Timeline
- Start date
- 2012-09-01
- Primary completion
- 2014-05-01
- Completion
- 2014-05-01
- First posted
- 2012-10-15
- Last updated
- 2014-05-28
Locations
6 sites across 3 countries: Poland, The Bahamas, United Kingdom
Source: ClinicalTrials.gov record NCT01706861. Inclusion in this directory is not an endorsement.