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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01681745
First Posted: September 10, 2012
Last Update Posted: April 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
MyoScience, Inc
  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: Intervention Model: Single Group Assignment
Masking: None (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 ]
    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 ]
    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 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment Device: Treatment with Cryo-Touch III

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01681745


Locations
United States, California
77 Plastic Surgery
San Francisco, California, United States, 94102
Sponsors and Collaborators
MyoScience, Inc
  More Information

Responsible Party: MyoScience, Inc
ClinicalTrials.gov Identifier: NCT01681745     History of Changes
Other Study ID Numbers: MYO-0535
First Submitted: September 5, 2012
First Posted: September 10, 2012
Last Update Posted: April 18, 2016
Last Verified: April 2016