Completed

The Cutera Trusculpt Device For Thigh Circumference Reduction

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What is being tested

Trusculpt (Radio Frequency) Device

Device
Who is being recruted

Over 18 Years
+28 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: August 2012
See protocol details

Summary

Principal SponsorCutera Inc.
Last updated: February 21, 2023
Sourced from a government-validated database.Claim as a partner

Study start date: August 1, 2012

Actual date on which the first participant was enrolled.

The primary efficacy variable for this study is the comparison of mean change in thigh circumference from baseline to 12 weeks between two arms. The primary research hypothesis is that the mean change in thigh circumference is ≥ 1 cm (indicating mean reduction).

NCT01665118
Principal SponsorCutera Inc.
Last updated: February 21, 2023
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

44 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Criteria

Female

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers allowed

If individuals who are healthy and do not have the condition being studied can participate.

Criteria

9 inclusion criteria required to participate
Body Mass Index (BMI) <= 30
Female
Minimum age of 18 years
Non-smoking for at least 3 months and willing to refrain from smoking for the duration of the study
Show More Criteria
19 exclusion criteria prevent from participating
Any disease or condition that could impair wound healing
Arteriosclerosis or weakened blood vessels
Bleeding disorders
Diabetes
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Trusculpt (Radio Frequency) Device

Group II

No Intervention
To be used as the self control in this split body study.

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 3 locations

Cutera Research Center

Brisbane, United StatesOpen Cutera Research Center in Google Maps

New Jersey Plastic Surgery

Montclair, United States

Nashville Center for Laser and Facial Surgery

Nashville, United States
Completed3 Study Centers