NCT00953290

Brief Summary

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction of thigh circumference.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
4

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2009

Geographic Reach
1 country

1 active site

Status
terminated

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

January 1, 2009

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

August 4, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 6, 2009

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2010

Completed
1.3 years until next milestone

Results Posted

Study results publicly available

April 18, 2011

Completed
Last Updated

May 10, 2011

Status Verified

May 1, 2011

Enrollment Period

1 year

First QC Date

August 4, 2009

Results QC Date

February 17, 2011

Last Update Submit

May 6, 2011

Conditions

Reduction of Localized Excess Fat

Keywords

CelluliteAdipose tissueCircumferenceReductionThigh

Outcome Measures

Primary Outcomes (2)

  • Difference in Circumference of Upper Thigh Between Treated and Untreated Control Arms

    Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]

    Baseline and 6 months post final treatment

  • Difference in Circumference of Mid Thigh Between Treated and Untreated Control Arms

    Mean difference of change from baseline between two arms: \[Treated arm - Untreated arm\]

    Baseline and 6 months post final treatment

Secondary Outcomes (2)

  • Subject Satisfaction

    Baseline and 6 months post final treatment

  • Adverse Events

    At each visit (treatment and follow-up) or until resolution of AEs

Study Arms (2)

Treated Thigh

EXPERIMENTAL

The thigh treated with the RF device

Device: Cutera Radio Frequency Device

Untreated Thigh

NO INTERVENTION

The untreated thigh

Interventions

Cutera Radio Frequency DeviceDEVICE

Up to three treatments, one pass, dosage range of 15-60 kJ.

Also known as: Callisto, TruForm, TruSculpt
Treated Thigh

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body Mass Index between 20 and 35
  • Presence of cellulite grades II, III or IV according to GLD scale
  • Visible bi-lateral thigh fat Thigh area to be treated to measure at least 30.0mm in vertical fold, as measured with industry standard fat caliper
  • Subject must be able to read, understand and sign the Consent Form
  • Subject must adhere to the follow-up schedule and study instructions
  • Subject must adhere to the same diet and/or exercise routine throughout the study

You may not qualify if:

  • Significant weight fluctuation (+/-10 lbs) in the past 6 months
  • Taking weight-loss medications/supplements
  • Participation in any other clinical study
  • Cellulite treatment within 3 months of the treatment
  • Surgical or non-surgical treatments to the target area in the last 12 months, e.g., liposuction
  • Prior treatment to the target area within the last 12 months
  • Arteriosclerosis or weakened blood vessels
  • Heart disease
  • Thromboembolic disease
  • Diagnosed or documented immune system disorders
  • Bleeding disorders.
  • Presence of uncontrolled hypertension
  • Taking prescription anticoagulants
  • History of keloid formation
  • Malignant tumors in the target area
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Blackhawk Plastic Surgery

Danville, California, 94506, United States

Location

MeSH Terms

Conditions

Cellulite

Condition Hierarchy (Ancestors)

Skin ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Limitations and Caveats

Early termination of the study resulting in analysis of small numbers of subjects, and technical issues with repeatability and reproducibility of circumference measurements leading to termination.

Results Point of Contact

Title
Ayse Turley, Clinical Development Researcher
Organization
Cutera Inc.
aturley@cutera.com
415-657-5665

Study Officials

  • Stephen J. Ronan, MD

    PRINCIPAL INVESTIGATOR

  • Jacqueline Calkin, MD

    PRINCIPAL INVESTIGATOR

  • Christine Lee, MD

    PRINCIPAL INVESTIGATOR

  • Scott Kramer, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

January 1, 2009

Primary Completion

January 1, 2010

Study Completion

January 1, 2010

Last Updated

May 10, 2011

Results First Posted

April 18, 2011

Record last verified: 2011-05

Locations

US(1)