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Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

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.
 
ClinicalTrials.gov Identifier: NCT01373827
Recruitment Status : Completed
First Posted : June 15, 2011
Last Update Posted : March 26, 2012
Sponsor:
Information provided by:
Sound Surgical Technologies, LLC.

Tracking Information
First Submitted Date June 14, 2011
First Posted Date June 15, 2011
Last Update Posted Date March 26, 2012
Study Start Date June 2011
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
Official Title Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.
Brief Summary Patients enrolled in this study will come from the Investigator's patient population and be ordinarily suitable for treatment using the MC1 device. The treatment they receive will be no different if they participate than if they do not. The study is only to observe the patients before, during and after their usual treatment.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population All subjects presenting to the investigator for treatment using the MC1 are potential study candidates and will be screened for eligibility. Every effort will be made to establish eligibility of the participants before enrollment. Subjects who do not meet all inclusion/exclusion criteria will not be enrolled. Enrollment in the study occurs at the time the patient is randomized to the assigned treatment.
Condition Patients Treated With VaserShape MC1
Intervention Device: VASERShape MC1
Use of the VASERShape MC1 device as part of routine practice
Study Groups/Cohorts MC1 Subjects
Intervention: Device: VASERShape MC1
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: March 23, 2012)
7
Original Estimated Enrollment
 (submitted: June 14, 2011)
10
Actual Study Completion Date March 2012
Actual Primary Completion Date March 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  1. Healthy Female between 20 and 50 years of age, inclusive, on the day of enrolment.
  2. Has a BMI between 20 and 30 kg/m2.
  3. Is to be treated in the posterior thigh / saddlebag area using the MC1.
  4. Has never been treated with the MC1 before.
  5. Females who are post menopausal or using a medically acceptable form of birth control prior to study enrollment and during the course of the study. (i.e., condoms with spermicide, oral contraceptives contraceptive implants etc.)

Exclusion Criteria:

  1. Subject is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female subjects of child-bearing potential), or intends to become pregnant during the study.
  2. Currently enrolled in another device or drug study that has not completed the required follow-up period, or has completed all other study-required follow-up less than 30 days before enrolment in this study.
  3. Keloid scars, hypertorphic scars or a history of abnormal healing.
  4. Any known bruising disorder, anticoagulative / thromboembolic condition , hemorrhagic (bleeding) status or use of anti coagulants.
  5. Tissue ischemia in the area to be treated.
  6. Suffering from concurrent conditions such as liver or kidney disorders, Hypertension or abnormally high blood pressure.
  7. High cholesterol and/or diabetes.
  8. Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
  9. Epilepsy.
  10. Tuberculosis.
  11. Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
  12. Suffering from Endocrine syndromes or thyroid hyperfunction.
  13. Active skin infection, any infection in the treated area within the last 30 days or skin disease in the area to be treated (e.g. eczema, psoriasis, urticaria, dermographism).
  14. Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
  15. Malignancy in the area to be treated.
  16. Laminectomy in the area to be treated.
Sex/Gender
Sexes Eligible for Study: Female
Ages 20 Years to 50 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01373827
Other Study ID Numbers SST2011-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Roy G Geronemus, MD, Laser & Skin Surgery Center of New York
Study Sponsor Sound Surgical Technologies, LLC.
Collaborators Not Provided
Investigators Not Provided
PRS Account Sound Surgical Technologies, LLC.
Verification Date March 2012