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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 30

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cryo-Touch Treatment	Cryo-Touch III	Initial treatment with Cryo-Touch III and three optional re-treatments (up to 4 treatments) performed 68 days to 1 day prior to abdominoplasty.

Primary Outcome Measures

Name	Time	Method
Biological Tissue Response	7 days	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.

Secondary Outcome Measures

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