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
  Purpose

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.


Condition Intervention
Patients Treated With VaserShape MC1
Device: VASERShape MC1

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.

Further study details as provided by Sound Surgical Technologies, LLC.:

Enrollment: 7
Study Start Date: June 2011
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
MC1 Subjects Device: VASERShape MC1
Use of the VASERShape MC1 device as part of routine practice

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01373827

Locations
United States, New York
Laser & Skin Surgery Center of New York
New York, New York, United States, 10016
Sponsors and Collaborators
Sound Surgical Technologies, LLC.
  More Information

No publications provided

Responsible Party: Roy G Geronemus, MD, Laser & Skin Surgery Center of New York
ClinicalTrials.gov Identifier: NCT01373827     History of Changes
Other Study ID Numbers: SST2011-2
Study First Received: June 14, 2011
Last Updated: March 23, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Sound Surgical Technologies, LLC.:
VASER
VASERShape
MC1
ultrasound

ClinicalTrials.gov processed this record on October 23, 2014