RecruitingNot ApplicableNCT03782038

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

A Prospective, Multi-center, Pilot Study to Evaluate the Safety and Efficacy of the Cytrellis Micro-Coring Device for the Treatment of Scars

Sponsor

Cytrellis Biosystems, Inc.

Enrollment

30 participants

Start Date

Sep 13, 2018

Study Type

INTERVENTIONAL

Conditions

A study to evaluate the safety and effectiveness of a micro coring device for the treatment of scars.

Min Age: 18 Years

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.

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