Subcutaneous Contouring Using High Intensity Focused Ultrasound

This study has been completed.
Sponsor:
Information provided by:
Medicis Technologies Corporation
ClinicalTrials.gov Identifier:
NCT01104272
First received: April 9, 2010
Last updated: January 17, 2011
Last verified: January 2011
  Purpose

The device delivers High Intensity Focused Ultrasound (HIFU) energy that can disrupt subcutaneous adipose tissue (SAT) to provide a non-invasive approach to body sculpting, such as a reduction in waist circumference.


Condition Intervention
Body Sculpting
Device: LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: An Evaluation of the Treatment of Adipose Tissue Using a Focused Ultrasound Device in Subjects With Fitzpatrick IV-VI Skin Types

Resource links provided by NLM:


Further study details as provided by Medicis Technologies Corporation:

Primary Outcome Measures:
  • Change from baseline in waist circumference [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • The change from Baseline in waist circumference measured after treatment, for the average of the two waist circumference measurements at the iliac crest as well as for each of the individual measurements. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Patient satisfaction as recorded on the Subject Satisfaction Survey after treatment. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]
  • Visual Analog Scale (VAS) diary to record post treatment discomfort. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator. [ Time Frame: 1 week ] [ Designated as safety issue: No ]
  • Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator. [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
  • Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator. [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
  • Improvement as determined by a Global Aesthetic Improvement Scale (GAIS) score of 'improved' or 'much improved' at each post-baseline visit, as assessed by the Investigator. [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 36
Study Start Date: April 2010
Study Completion Date: January 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Energy Level 1
Subcutaneous Adipose Tissue Treated With Energy Level 1.
Device: LipoSonix (Ultrasound treatment of Subcutaneous Adipose Tissue)
Study of Adipose Tissue Treatment Using Focused Ultrasound

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

All of the following inclusion criteria must be met at the time of screening before the subject is enrolled into the study:

  1. Male or female subjects, 18 to 65 years of age
  2. Body Mass Index ≤30
  3. Thickness of subcutaneous adipose tissue in the anticipated treatment area of ≥ 2.5 cm
  4. Subjects must agree to not alter their normal and regular diet or exercise routines during the course of the study.
  5. Subjects must be of African descent AND have Fitzpatrick skin types IV, V, or VI.

Exclusion Criteria:

A subject is ineligible to participate in this study if they meet any of the following exclusion criteria at screening:

  1. Female subject who is pregnant (i.e., has a positive urine pregnancy test), is suspected to be pregnant, or is lactating or becomes pregnant during the course of the study. (NOTE: Females of childbearing potential must have a negative urine pregnancy test prior to enrollment in the study.)
  2. Subjects diagnosed with coagulation disorders or are receiving anticoagulant therapy or medications or dietary supplements which impede coagulation or platelet aggregation.
  3. Subject has diabetes or cardiovascular disease.
  4. Subject has had any aesthetic procedure to the region to be treated.
  5. Subject has systemic skin disease or skin disease in the areas to be treated.
  6. Subject has any abnormality of the skin or soft tissues of the abdominal wall in the areas to be treated.
  7. Subject has had previous open or laparoscopic surgery in the anticipated treatment area.
  8. Subjects is on prescription or over the counter weight reduction medication or programs, or had weight reduction procedures (e.g.: gastric bypass, Lap-Band, etc.)
  9. Subject has skin or superficial tissue that does not lie flat on its own when the subject is in the supine position.
  10. Subjects undergoing chronic steroid or immunosuppressive therapy.
  11. Subjects who have cardiac pacemakers or any implantable electrical device, e.g. pacemaker, defibrillator, or neurostimulators.
  12. Subjects who have metal implants of any type in the area to be treated.
  13. History of cancer.
  14. Subjects who have sensory loss or dysesthesia in the area to be treated.
  15. Subject currently uses illicit drug(s) or abuses alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day).
  16. Subjects who cannot adhere to the study visit schedule (e.g., subjects not likely to stay in the study for a maximum of 27 weeks - screening through exit visit).
  17. Subjects who are unable, or lack the capacity, to self consent.
  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: NCT01104272

Locations
Canada, Ontario
Institute of Cosmetic and Laser Surgery
Oakville, Ontario, Canada, L6J7W5
Dr. Nowell Solish Private Office
Toronto, Ontario, Canada, M5R3N8
Sponsors and Collaborators
Medicis Technologies Corporation
Investigators
Principal Investigator: Nowell Solish, MD Dr. Nowell Solish Private Office
Principal Investigator: Sheetal Sapra, MD Institute of Cosmetic and Laser Surgery
  More Information

No publications provided

Responsible Party: Patrick Martin, Executive Director, Clinical Affairs, Medicis Technologies Corporation
ClinicalTrials.gov Identifier: NCT01104272     History of Changes
Other Study ID Numbers: LP-1100-05
Study First Received: April 9, 2010
Last Updated: January 17, 2011
Health Authority: Canada: Health Canada

Keywords provided by Medicis Technologies Corporation:
Ultrasound Treatment of Subcutaneous Adipose Tissue

ClinicalTrials.gov processed this record on September 18, 2014