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

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.

Study Overview

• Status: Completed
• Conditions: Histological Response of Tissue to Cold
• Intervention / Treatment: Device: Cryo-Touch III

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94102
      • 77 Plastic Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cryo-Touch Treatment; 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; Other Names: PCP 1.0

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Pacira Pharmaceuticals, Inc

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2012
• Primary Completion (Actual): April 1, 2015
• Study Completion (Actual): April 1, 2015

Study Registration Dates

• First Submitted: September 5, 2012
• First Submitted That Met QC Criteria: September 7, 2012
• First Posted (Estimated): September 10, 2012

Study Record Updates

• Last Update Posted (Estimated): January 24, 2024
• Last Update Submitted That Met QC Criteria: January 22, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: MYO-0535

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO