18 and older, any sex, with Tissue Heating or Coagulation. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Subject SatisfactionPrimary· 30 days post final treatment
The subject will be asked their level of satisfaction using a 6-point Likert scale that ranges from "extremely satisfied" to "extremely unsatisfied," with 1 being extremely unsatisfied and 6 being extremely satisfied.
Group
Value
95% CI
Women's Health
0
Skin Rejuvenation
6
Surgical- Blepharoplasty
4
Women's Health
2
Skin Rejuvenation
14
Surgical- Blepharoplasty
5
Women's Health
4
Skin Rejuvenation
11
Surgical- Blepharoplasty
1
Women's Health
2
Skin Rejuvenation
1
Surgical- Blepharoplasty
0
Number of Tissue Samples With Successful ResultsPrimary· Immediately Post Treatment (Same Day)
This is the number of tissue samples removed by the device (on 1 subject) that has similar histological results to scalpels and cautery devices currently on the market.
Group
Value
95% CI
Surgical- Abdominoplasty
20
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events occurring were captured and followed through study completion, an average of 7 months. Subjects were instructed that they may contact the Investigator at any time throughout the course of the study..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
NCT05096247 — Post Market Study To Collect Efficacy Data For The Treatment Of Wrinkles With A Radiofrequency Device
· NA
· completed
NCT04569253 — Multi-Center Pivotal Study of Radiofrequency Device
· NA
· completed
Other Cynosure, Inc. trials
Trials by the same sponsor.
NCT05847530 — Pilot Evaluation of the Cynosure Potenza™ System for Treatment of Cosmetic Dermatologic Skin Conditions
· NA
· completed
NCT06023303 — Prospective Clinical Study to Assess Safety and to Collect Data on Radiofrequency Microneedling Device(s) For the Purpos
· NA
· completed
NCT05590039 — Study To Evaluate The Safety And Efficacy Of The MyEllevate® Procedure
· NA
· completed
NCT05388604 — Clinical Study To Evaluate Paired Treatment With An Alexandrite Laser And Radiofrequency Microneedling For Facial Aging
· NA
· completed
NCT05388617 — Study To Assess Radiofrequency Diathermocontraction Device For Muscle Stimulation And The Treatment Of Abdominal Fat
· NA
· terminated
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Cynosure, Inc.
Last refreshed: 4 April 2022
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05166824.