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CompletedNCT03428243Updated Mar 20, 2018

Long-term Follow-up Study of the truSculpt Radiofrequency Device for Circumferential Reduction

An observational study in Abdominal Fat, sponsored by Cutera Inc.. Completed at 1 site in United States. Open to participants aged 24 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-03-20.

Sponsored by Cutera Inc. · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
14
Ages
24 Years to 60 Years
Sex
All
01

Study summary

A long-term follow-up study to evaluate the safety and efficacy of the Cutera truSculpt radiofrequency device for circumferential reduction.

Read the detailed description

The purpose of this investigation is to follow-up subjects who have completed participation in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction" for the long-term (18 months) safety and efficacy of the truSculpt radiofrequency (RF) device for circumferential reduction in the abdominal and flank region.

02

Conditions studied

  • Abdominal Fat
03

Who can participate

Ages eligible
24 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

14 Subjects from C-16-TS11 participants followed up for measurement

Inclusion criteria

  1. Completed participation in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction"
  2. Subject has maintained the same weight since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction", within 5% of baseline weight measurement.

Exclusion criteria

Exclusion Criteria:

  1. Participation in a clinical trial of another device or drug in the target area since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
  2. Any type of cosmetic treatment to the target area to reduce circumference since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction" e.g., radiofrequency, cryolysis or light-based treatments.
  3. Any invasive cosmetic surgery to the target area, such as liposuction, since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
  4. Newly diagnosed (since enrolling in Protocol C-16-TS11) significant concurrent illness, such as diabetes mellitus, cardiovascular disease, peripheral vascular disease or pertinent neurological disorders.
  5. Newly diagnosed or documented (since enrolling in Protocol C-16-TS11) immune system disorders.
  6. Current infection, dermatitis, rash or other skin abnormality in the treatment area.
  7. Currently undergoing systemic chemotherapy or radiation treatment for cancer, or treatment in the target area since enrolling in Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction".
  8. Pregnant or currently breastfeeding.
  9. As per the Investigator's discretion, any physical or mental condition which might make unsafe for the subject to participate in this study.
04

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
14 participants (actual)
Patient registry
No

Groups and cohorts

  • truSculpt

    truSculpt effectiveness after 18 months

    Device: truSculpt

Interventions

  • DevicetruSculpt

    Device comparison of Circumference measurement at Baseline vs 18 months post treatment

05

What researchers measure

Primary outcomes

  1. Circumference Measurement

    Comparison of Abdominal region Measurement in cm 18 months post-treatment with C-16 TS11 Baseline.

    Time frame: 18 months post C-16-TS11 completion (September, 2016)

Secondary outcomes

  1. Device Safety

    Measurement of Resolved Adverse Events from Radiofrequency (RF) treatment (C-16-TS11), and Presence of any Additional AE within 18 months of RF treatment.

    Time frame: 18 months post C-16-TS11 completion (September, 2016)

06

Study locations

1 site
  • Cutera Research Center
    Brisbane, California 94005, United States
07

Registry details

Key details

Study ID
NCT03428243
Lead sponsor
Cutera Inc.
Responsible party
Sponsor
First posted
Feb 9, 2018
Start date
Jul 12, 2017
Primary completion
Nov 6, 2017
Completion
Dec 1, 2017
Last update
Mar 20, 2018

Study contacts

Stephen Ronan, MD
principal investigator · Principal Investigator

Oversight

FDA-regulated drug
No
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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Cutera Inc.

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