NCT01260298

Brief Summary

The objective of this study is to observe body contour changes following treatment using the MC1 device.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2010

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

December 13, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 15, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2011

Completed
Last Updated

March 11, 2011

Status Verified

March 1, 2011

Enrollment Period

3 months

First QC Date

December 13, 2010

Last Update Submit

March 9, 2011

Conditions

Females Scheduled to be Treated Using the MC1.

Keywords

MC1 VASER VASERShape

Study Arms (1)

MC1 Ultrasonic Device

Device: MC1 Ultrasonic Device

Interventions

MC1 Ultrasonic DeviceDEVICE

Ultrasonic and zonal massage device.

Also known as: MC1, VASERShape
MC1 Ultrasonic Device

Eligibility Criteria

Age20 Years - 50 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Female between the ages of 20 and 50 years with BMI between 20 and 30 who are scheduled to be treated using the MC1 device.

You may qualify if:

  • Is female.
  • Is 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 infra-scapular area using the MC1.
  • Has never been treated with the MC1 before.

You may not qualify if:

  • Patient is lactating, has a positive pregnancy test within 7 days of planned study procedure (for female patients of child-bearing potential), or intends to become pregnant during the study or is not using effective methods to prevent pregnancy.
  • 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, hypertrophic scars or a history of abnormal healing.
  • Thrombophlebitis.
  • Bleeding or bruising disorders (e.g. idiopathic thrombocytopenic purpura, anticoagulated patients).
  • Tissue ischemia in the area to be treated.
  • Hypertension or abnormally high blood pressure.
  • High cholesterol.
  • Active collagen vascular disease (e.g. fibromyalgia, panniculitis, lupus etc.).
  • Diabetes.
  • Epilepsy.
  • Tuberculosis.
  • Auxiliary electric organs (such as pacemakers), metal or myoelectric prosthesis.
  • Endocrine syndromes or thyroid hyperfunction.
  • Any type of hemorrhagic (bleeding) status.
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Skin Care Physicians

Chestnut Hill, Massachusetts, 02467, United States

Location

Study Officials

  • Michael Kaminer, MD

    SkinCare Physicians

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

December 13, 2010

First Posted

December 15, 2010

Study Start

December 1, 2010

Primary Completion

March 1, 2011

Study Completion

March 1, 2011

Last Updated

March 11, 2011

Record last verified: 2011-03

Locations

US(1)