Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects

Study Overview
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Brief Summary
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This study is designed to characterize the biological response of the epidermis, dermis and subcutaneous tissue to treatment with the Myoscience Cryo-Touch III system.

Official Title
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Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects

Conditions
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Histological Response of Tissue to Cold

Intervention / Treatment
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* Device: Cryo-Touch III


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female, 18 to 70 years old Subject is willing and able to give written informed consent. Subject is committed to undergo an abdominoplasty procedure independent of this study. Subject is willing and able to comply with study instructions and commit to all visits for the duration of the study. Subject is in good general health and free of any disease state or physical condition that might impair evaluation or which in the investigator's opinion, expose the subject to an unacceptable risk by study participation. Exclusion Criteria: Subject is currently enrolled in an investigational drug or a device study that specifically targets the abdominal area. Subject currently smokes. Subject has a clotting disorder and/or has used an anticoagulant (e.g., warfarin, clopidogrel, etc.) within seven (7) days prior to administration of the device. Subject has used oral or inhaled steroids in the last 14 days and/or has been a chronic user of inhaled or oral steroids in the past such that the investigator feels subject may have compromised wound healing. Subject has used topical steroids in the abdominal area within the last 30 days. Subject is on any systemic immunosuppressive therapy. Subject has had prior surgery and/or treatment that alters the subcutaneous anatomy of the target treatment sites: liposuction, cryolipolysis, or high-intensity focused ultrasound. History of abdominal hernia. Subject has any of the following conditions: Allergy or intolerance to lidocaine, Other local skin condition (e.g., skin infection) at target treatment site, Any physical or psychiatric condition that in the investigator's opinion would prevent adequate study participation. Chronic medical condition or use of medication that in the investigator's opinion would affect study participation or wound healing (such as diabetes, hepatitis, HIV, etc.). Subject is known to be noncompliant or is unlikely to comply with the requirements of the study protocol (e.g., due to alcoholism, drug dependency, mental incapacity) in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Subjects' abdomens treated with Myoscience device (cryoneurolysis) at various timepoints prior to an abdominoplasty. Skin examined visually and resected for histological examination.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cryo-Touch Treatment<br>Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty. | Device: Cryo-Touch III<br> <br> * Other names: PCP 1.0;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biological Tissue Response | The biological response of the treated tissue by the Cryo-Touch III or Cryo-Touch IV device was determined through gross pathology and histological assessment. | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs) | All anticipated observations, adverse events and SAEs/UADEs were assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) were recorded. | 7 days |