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

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

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 will be assessed on the following:

• POSAS - Patient Observer Scar Assessment
• ASAS - Acne Scar Severity Scale
• Subject Satisfaction Scale

Inclusion Criteria:

• 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 Criteria:

• 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