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

NCT01681745 | Completed Results

• 1 other identifier: MYO-0535
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Number of Participants With Serious Adverse Events (SAEs) and Unanticipated Adverse Events (UADEs)

  7 days

Study Arms (1)

Cryo-Touch Treatment

EXPERIMENTAL

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

Interventions

Cryo-Touch III DEVICE

Also known as: PCP 1.0

Cryo-Touch Treatment

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pacira Pharmaceuticals, Inc: lead

Study Sites (1)

77 Plastic Surgery

San Francisco, California, 94102, United States

Location

Limitations and Caveats

During transfer and acquisition of study record by sponsors, no study data has been located and all efforts to locate study data have been exhausted. Therefore, no study data is available to report at this time.

Results Point of Contact

• Title: Kent Jones/ Sr. Director Quality and Medical Affairs
• Organization: Pacira Cryotech, Inc.

kent.jones@pacira.com

(510)933-1513

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Subjects' abdomens treated with Myoscience device (cryoneurolysis) at various timepoints prior to an abdominoplasty. Skin examined visually and resected for histological examination.

Study Record Dates

• First Submitted: September 5, 2012
• First Posted: September 10, 2012
• Study Start: June 1, 2012
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: January 24, 2024
• Results First Posted: March 11, 2021

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)