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OpenTrials
Completed

NCT Number: NCT01373827

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.

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Key information

Age range

20 year–50 year

Sex eligibility

Female

Study type

Observational

Primary location

Laser & Skin Surgery Center of New York

New York, 10016, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Female between 20 and 50 years of age, inclusive, on the day of enrolment.
  • Has a BMI between 20 and 30 kg/m2.
  • Is to be treated in the posterior thigh / saddlebag area using the MC1.
  • Has never been treated with the MC1 before.
  • 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

  • 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.
  • 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.
  • Keloid scars, hypertorphic scars or a history of abnormal healing.
  • Any known bruising disorder, anticoagulative / thromboembolic condition , hemorrhagic (bleeding) status or use of anti coagulants.
  • Tissue ischemia in the area to be treated.
  • Suffering from concurrent conditions such as liver or kidney disorders, Hypertension or abnormally high blood pressure.
  • High cholesterol and/or diabetes.
  • Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
  • Epilepsy.
  • Tuberculosis.
  • Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
  • Suffering from Endocrine syndromes or thyroid hyperfunction.
  • 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).
  • Bone, muscle or joint disease, dysfunction or healing in the area to be treated.
  • Malignancy in the area to be treated.
  • Laminectomy in the area to be treated.

Treatment and study plan

VASERShape MC1

Device

Use of the VASERShape MC1 device as part of routine practice

Sponsors and collaborators

Lead sponsor

Sound Surgical Technologies, LLC.

Industry

Registry information

Official study title

Protocol To Evaluate Patient Measurements After Ultrasonic Treatment.

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Jun 15, 2011
Registry last updated
Mar 26, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.