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

This study is currently recruiting participants.
Verified September 2012 by MyoScience, Inc
Sponsor:
Information provided by (Responsible Party):
MyoScience, Inc
ClinicalTrials.gov Identifier:
NCT01681745
First received: September 5, 2012
Last updated: September 7, 2012
Last verified: September 2012
  Purpose

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.


Condition Intervention Phase
Histological Response of Tissue to Cold
Device: Treatment with Cryo-Touch III
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Probe Configuration and Time-Temperature Dose Ranging for Understanding of Skin Lesion Effects

Further study details as provided by MyoScience, Inc:

Primary Outcome Measures:
  • Tissue Response [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    The biological response of the treated tissue by the Cryo-Touch III device through gross pathology and histological assessment


Secondary Outcome Measures:
  • Safety [ Time Frame: 7 days ] [ Designated as safety issue: Yes ]
    All anticipated observations, adverse events and SAEs/UADEs will be assessed. Incidence of serious adverse events (SAEs) and unanticipated adverse device effects (UADEs) will be recorded.


Estimated Enrollment: 30
Study Start Date: August 2012
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: Treatment with Cryo-Touch III

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01681745

Contacts
Contact: John Allison, PhD 650-474-2600 jallison@myoscience.com
Contact: Tracey Henry 650-474-2600 thenry@myoscience.com

Locations
United States, California
77 Plastic Surgery Recruiting
San Francisco, California, United States, 94102
Principal Investigator: LARRY K FAN, MD         
Sponsors and Collaborators
MyoScience, Inc
  More Information

No publications provided

Responsible Party: MyoScience, Inc
ClinicalTrials.gov Identifier: NCT01681745     History of Changes
Other Study ID Numbers: MYO-0535
Study First Received: September 5, 2012
Last Updated: September 7, 2012
Health Authority: United States: Food and Drug Administration

ClinicalTrials.gov processed this record on April 14, 2014