Clinical trial NCT01681745: Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects
Official title: Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Histological Response of Tissue to Cold
Lead sponsor: Pacira Pharmaceuticals, Inc
Sponsor class: INDUSTRY
First posted: 2012-09-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Subjects' abdomens treated with Myoscience device (cryoneurolysis) at various timepoints prior to an abdominoplasty. Skin examined visually and resected for histological examination.
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Biological Tissue Response
timeFrame: 7 days
Secondary outcomes:
measure: Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)
timeFrame: 7 days
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: 77 Plastic Surgery
state: California
Study officials:
References: