Long-term Follow-up Study of the truSculpt Radiofrequency... | NCT03428243

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

NCT03428243

Sponsor

Cutera Inc.

Status

Completed

Last Update Posted

Mar 20, 2018Actual

Enrollment

14Actual

Phase

Not provided

Conditions

Abdominal Fat

Interventions

truSculpt

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 12, 2017Actual

Primary Completion Date

Nov 6, 2017Actual

Completion Date

Dec 1, 2017Actual

First Submitted Date

Feb 5, 2018

First Submission Date that Met QC Criteria

Feb 5, 2018

First Posted Date

Feb 9, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 19, 2018

Last Update Posted Date

Mar 20, 2018Actual

Description Module

Brief Summary

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

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

14Actual

Label	Type	Description	Intervention Names
truSculpt		truSculpt effectiveness after 18 months	Device: truSculpt

Name	Type	Description	Arm Group Labels	Other Names
truSculpt	Device	Device comparison of Circumference measurement at Baseline vs 18 months post treatment	truSculpt

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Circumference Measurement	Comparison of Abdominal region Measurement in cm 18 months post-treatment with C-16 TS11 Baseline.	18 months post C-16-TS11 completion (September, 2016)

Secondary Outcomes

Measure	Description	Time Frame
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.	18 months post C-16-TS11 completion (September, 2016)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Completed participation in the Treatment Group of Protocol C-16-TS11 - "Pivotal Study of the TruSculpt Radiofrequency Device for Circumferential Reduction"
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:

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".
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.
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".
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.
Newly diagnosed or documented (since enrolling in Protocol C-16-TS11) immune system disorders.
Current infection, dermatitis, rash or other skin abnormality in the treatment area.
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".
Pregnant or currently breastfeeding.
As per the Investigator's discretion, any physical or mental condition which might make unsafe for the subject to participate in this study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

24 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Non-Probability Sample

Type	Date	Date Unknown
Release	Feb 22, 2023
Reset	Dec 1, 2023