NCT02512822

Brief Summary

To evaluate the efficacy of novel noninvasive RF technology for reduction of submental fat.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
21

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2013

Status
completed

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

November 1, 2013

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2015

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

July 27, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 31, 2015

Completed
Last Updated

July 31, 2015

Status Verified

July 1, 2015

Enrollment Period

1.2 years

First QC Date

July 27, 2015

Last Update Submit

July 30, 2015

Conditions

Subcutaneous Fat

Keywords

radiofrequencysubmental fatfat reductionbody contouring

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline in thickness of the submental fat at 6 months

    thickness of the submental fat measured by ultrasound

    6 months

  • Change from Baseline in submental circumference at 6 months

    thickness of the submental fat measured by a tape measure

    6 months

Secondary Outcomes (2)

  • participants' assessment for improvement at 6 months

    6 months

  • participants' assessment for satisfaction at 6 months

    6 months

Study Arms (1)

Participants

EXPERIMENTAL

Noninvasive Radiofrequency

Procedure: Noninvasive Radiofrequency TruSculpt

Interventions

Noninvasive Radiofrequency TruSculptPROCEDURE

Heating subcutaneous fat up to 45℃ continuously at least 3 minutes without surface damage and induces adipocytes apoptosis.

Also known as: TruSculpt
Participants

Eligibility Criteria

Age20 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • clinically appreciable localized excess of subcutaneous fat on the submental area
  • no history of systemic underlying disease

You may not qualify if:

  • any infectious or inflammatory skin diseases
  • keloids
  • psychiatric patients
  • systemic underlying disease
  • who had taken aesthetic procedure on the face, before 6-month
  • more than 5% weight change were dropped out.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Franco W, Kothare A, Ronan SJ, Grekin RC, McCalmont TH. Hyperthermic injury to adipocyte cells by selective heating of subcutaneous fat with a novel radiofrequency device: feasibility studies. Lasers Surg Med. 2010 Jul;42(5):361-70. doi: 10.1002/lsm.20925.

    PMID: 20583242BACKGROUND

  • Franco W, Kothare A, Goldberg DJ. Controlled volumetric heating of subcutaneous adipose tissue using a novel radiofrequency technology. Lasers Surg Med. 2009 Dec;41(10):745-50. doi: 10.1002/lsm.20876.

    PMID: 20014265BACKGROUND

Study Officials

  • Won-Serk Kim, M.D., Ph.D.

    Kangbuk Samsung Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

July 27, 2015

First Posted

July 31, 2015

Study Start

November 1, 2013

Primary Completion

January 1, 2015

Study Completion

July 1, 2015

Last Updated

July 31, 2015

Record last verified: 2015-07