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

NCT ID: NCT01681745

Last Updated: 2024-01-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 30 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-06-01
• Study Completion Date: 2015-04-01

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.

Conditions

Histological Response of Tissue to Cold

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Cryo-Touch III

Intervention Type: DEVICE

Interventions

Cryo-Touch III

Intervention Type: DEVICE

Other Intervention Names

PCP 1.0

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Pacira Pharmaceuticals, Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

77 Plastic Surgery

San Francisco, California, United States

Countries

United States

Other Identifiers

MYO-0535

Identifier Type: -

Identifier Source: org_study_id