Status:
UNKNOWN
Study to Evaluate the Efficacy of a Micro Coring Device for the Treatment of Scars of the Cytrellis Micro-Coring Device for the Treatment of Scars
Lead Sponsor:
Cytrellis Biosystems, Inc.
Conditions:
Scars
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.
Detailed Description
The study subject population will consist to up to 30 subjects who meet the inclusion/exclusion criteria. All subjects will be monitored for a period of 6 months post last treatment. An study results...
Eligibility Criteria
Inclusion
- 18 years of age or older
- Fitzpatrick scale I-VI.
- Any type of scar except for keloid scars
- Able to provide written informed consent, understand and willing to comply with study related procedures and follow-ups.
Exclusion
- Previous treatment of the scar tissue within last 6 months.
- Silicone, fat, collagen or synthetic material in the treatment area.
- History of keloid formation.
- Active smokers (smoking more than ½ pack per day) or having quit smoking (½ pack per day) for less than 3 months.
- Active, chronic, or recurrent infection.
- Compromised immune system (e.g. diabetes).
- Hypersensitivity to analgesic agents.
- Co-morbid condition that could limit ability to participate in the study or to comply with follow-up requirements.
- Pregnant or breastfeeding.
- Any issue that, at the discretion of the investigator, would contra-indicate the subject's participation.
- Any medication that may cause bleeding such as anticoagulants.
- Allergy to lidocaine and/or epinephrine
Key Trial Info
Start Date :
September 13 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 21 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03782038
Start Date
September 13 2018
End Date
November 21 2019
Last Update
December 21 2018
Active Locations (1)
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1
Miami Dermatology & Laser Institute
Miami, Florida, United States, 33173