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

Pacira Pharmaceuticals, Inc1 site in 1 country30 target enrollmentJune 1, 2012

ConditionsHistological Response of Tissue to Cold

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Histological Response of Tissue to Cold
Sponsor: Pacira Pharmaceuticals, Inc
Enrollment: 30
Locations: 1
Primary Endpoint: Biological Tissue Response
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 1, 2012

End Date

April 1, 2015

Last Updated

2 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Pacira Pharmaceuticals, Inc

Responsible Party

Sponsor

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,

Outcomes

Primary Outcomes

Biological Tissue Response

Time Frame: 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.