MedTrace Logo

Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device

NCT05166824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 89

Last updated 2022-04-04

Study results available
· View outcomes & findings →

Summary

The purpose of this study was to develop parameters and assess the safety of the radiofrequency device for a variety of treatments. Treatment results were also evaluated.

Conditions

  • Tissue Heating
  • Coagulation

Interventions

DEVICE

TempSure

Radiofrequency platform

DEVICE

Scalpel

Cold knife

DEVICE

Bovie

Electrosurgery and electrocautery platform

DEVICE

Pelleve

Radiofrequency platform

Sponsors & Collaborators

  • Cynosure, Inc.

    lead INDUSTRY

Principal Investigators

  • Jennifer Civiok · Cynosure, Inc.

  • Sean Doherty · Cynosure, Inc.

  • Raminder Saluja · Saluja Cosmetic and Laser Center

  • Barry DiBernardo · New Jersey Plastic Surgery

  • Edward Jaccoma · Excellent Vision

  • Jeffrey Dell · Institute of Female Pelvic Medicine

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-01-18
Primary Completion
2019-02-04
Completion
2019-02-04
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05166824 on ClinicalTrials.gov