NCT00953160

Brief Summary

The purpose of this study is to evaluate the Cutera radio frequency (RF) device for the new indication of reduction in size of localized areas of the body.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
76

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

5 active sites

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

April 1, 2009

Completed
4 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
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2010

Completed
9 months until next milestone

Results Posted

Study results publicly available

March 17, 2011

Completed
Last Updated

September 18, 2023

Status Verified

August 1, 2023

Enrollment Period

1.2 years

First QC Date

August 4, 2009

Results QC Date

February 25, 2011

Last Update Submit

August 29, 2023

Conditions

Cellulite

Keywords

CelluliteAdipose tissueCircumferenceReductionThighAbdomenFlank

Outcome Measures

Primary Outcomes (1)

  • Change in Circumference (cm)

    Baseline and 6 months post final treatment

Secondary Outcomes (2)

  • Subject Satisfaction

    Baseline and 6 months post final treatment

  • The Number of Participants With Adverse Events

    Up to 6 months after the last treatment

Study Arms (1)

RF treatment

EXPERIMENTAL

Abdomen, flank or thigh treated with RF device

Device: Cutera Radio Frequency Device

Interventions

Cutera Radio Frequency DeviceDEVICE

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

Also known as: Callisto, TruForm, TruSculpt
RF treatment

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female or Male
  • Minimum age of 18 years
  • Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study.
  • Post-menopausal, or on birth control with no plans to become pregnant for the duration of the study (female only)
  • Minimum Body Mass Index of 20
  • Visible fat in the area to be treated Area to be treated to measure at least 20.0mm 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, and agree to maintain the same weight throughout the study (within 6 lbs of initial weight)

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 (5)

Blackhawk Plastic Surgery

Danville, California, 94506, United States

Location

Renu LaserSpa

Dublin, California, 94568, United States

Location

Calkin/Boudreaux Dermatology Associates

Sacramento, California, 95825-6372, United States

Location

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Nashville Center for Laser and Facial Surgery

Nashville, Tennessee, 37203, 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

  • Brian Biesman, MD

    PRINCIPAL INVESTIGATOR

  • Jacqueline Calkin, MD

    PRINCIPAL INVESTIGATOR

  • Stephen Ronan, MD

    PRINCIPAL INVESTIGATOR

  • Scott Kramer, MD

    PRINCIPAL INVESTIGATOR

  • Adele Makow, MD

    PRINCIPAL INVESTIGATOR

  • Barry DiBernardo, 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
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 4, 2009

First Posted

August 6, 2009

Study Start

April 1, 2009

Primary Completion

July 1, 2010

Study Completion

July 1, 2010

Last Updated

September 18, 2023

Results First Posted

March 17, 2011

Record last verified: 2023-08

Locations

US(5)