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NCT05517824 Clinical Trial

Needle Radiofrequency Treatment for Submental Fat

Obese Clinical Trial

Official title:
Efficacy and Safety of the Micro-insulated Needle Radiofrequency Device for Reduction of Submental Fat

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT05517824
Other study ID # B-2012-655-001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date June 7, 2021
Est. completion date November 4, 2021

Study information
Verified date August 2022
Source Seoul National University Bundang Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The investigators aimed to evaluate the efficacy and safety of a fractional radiofrequency device with a micro-insulated needle to reduce submental fat.

Recruitment information / eligibility
Status Completed
Enrollment 24
Est. completion date November 4, 2021
Est. primary completion date November 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years and older
Eligibility Inclusion Criteria: - Patients with excess submental fat on a grade of 1~4, as assessed by the Physician-Assisted Submental Fat Rating Scale Exclusion Criteria: - mental impairment, infectious disease - history of keloid development - pregnancy, pacemaker - use of anticoagulants - undergoing a facelift procedure within the prior 6 months.

Study Design

Related Conditions & MeSH terms

Intervention

Procedure:
• microinsulated needle radiofrequency
A single treatment using a microinsulated needle radiofrequency device

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Bundang Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary Physician-Assisted Submental Fat Rating Scale score from 0 (nothing) to 4 (very severe) submental fat rating by an independent investigator 1 month after the treatment
Secondary submental fat volume (cc) fat volume quantified with a three-dimensional camera 1 month after the treatment
Secondary patient satisfaction score from 0 (not satisfied) to 10 (most satisfied) patient's satisfaction score for reduction of submental fat 1 month after the treatment
Secondary any adverse effects at any time during or after treatment adverse events assessed through study completion, an average of 2 months
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