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Protocol To Evaluate Patient Measurements After Ultrasonic Treatment

This study has been completed.
Sponsor:
Information provided by:
Sound Surgical Technologies, LLC.
ClinicalTrials.gov Identifier:
NCT01373827
First received: June 14, 2011
Last updated: March 23, 2012
Last verified: March 2012

June 14, 2011
March 23, 2012
June 2011
March 2012   (final data collection date for primary outcome measure)
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Complete list of historical versions of study NCT01373827 on ClinicalTrials.gov Archive Site
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Protocol To Evaluate Patient Measurements After Ultrasonic Treatment
Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
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Non-Probability Sample

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.

Patients Treated With VaserShape MC1
Device: VASERShape MC1
Use of the VASERShape MC1 device as part of routine practice
MC1 Subjects
Intervention: Device: VASERShape MC1
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7
March 2012
March 2012   (final data collection date for primary outcome measure)

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.
Female
20 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01373827
SST2011-2
No
Roy G Geronemus, MD, Laser & Skin Surgery Center of New York
Sound Surgical Technologies, LLC.
Not Provided
Not Provided
Sound Surgical Technologies, LLC.
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP