NCT05166824

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
89

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2017

Typical duration for not_applicable

Geographic Reach
1 country

5 active sites

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

January 18, 2017

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 4, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 4, 2019

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

December 8, 2021

Completed
14 days until next milestone

First Posted

Study publicly available on registry

December 22, 2021

Completed
3 months until next milestone

Results Posted

Study results publicly available

April 4, 2022

Completed
Last Updated

April 4, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

December 8, 2021

Results QC Date

February 14, 2022

Last Update Submit

March 9, 2022

Conditions

Tissue HeatingCoagulation

Outcome Measures

Primary Outcomes (2)

  • Subject Satisfaction

    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.

    30 days post final treatment

  • Number of Tissue Samples With Successful Results

    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.

    Immediately Post Treatment (Same Day)

Study Arms (4)

Surgical- abdominoplasty

EXPERIMENTAL

Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the abdomen. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.

Device: TempSureDevice: ScalpelDevice: Bovie

Women's Health

EXPERIMENTAL

Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.

Device: TempSure

Skin Rejuvenation

EXPERIMENTAL

The hand piece, applicator or tip was placed in contact with the skin. The entire defined treatment area was treated by delivering energy to the skin. The hand piece, number of passes and parameters used for the treatment was determined by the Investigator.

Device: TempSureDevice: Pelleve

Surgical- blepharoplasty

EXPERIMENTAL

Subjects enrolled in the surgical arm were treated with the device being placed in contact with the skin on the eyelids. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.

Device: TempSure

Interventions

TempSureDEVICE

Radiofrequency platform

Skin RejuvenationSurgical- abdominoplastySurgical- blepharoplastyWomen's Health
ScalpelDEVICE

Cold knife

Surgical- abdominoplasty
BovieDEVICE

Electrosurgery and electrocautery platform

Surgical- abdominoplasty
PelleveDEVICE

Radiofrequency platform

Skin Rejuvenation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • A healthy male or female 18 years of age or older.
  • Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
  • Understands and accepts the obligation and is logistically able to be present for all visits.
  • Is willing to comply with all requirements of the study and sign the informed consent document.

You may not qualify if:

  • Is pregnant or of child bearing potential and not using medically effective birth control or has been pregnant in the last 3 months, currently breast feeding or planning a pregnancy during the course of the study.
  • The subject has active or localized systemic infections.
  • The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
  • Any other types of cosmetic treatments in the area to be treated in the past 6 months are cautioned and determined at the discretion of the investigator.
  • The subject has a history of keloids.
  • The subject has evidence of active systemic or local skin disease that may alter wound healing.
  • The subject has scarring or wounds in the treatment area that would interfere with study assessments.
  • The subject has a metal implant (such as but not limited to; titanium orbit or metal chin repair) in the face or head that would interfere with study treatment, or subject has an electronic implantable device (such as but not limited to; pacemakers and embedded defibrillators).
  • The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Cynosure

Westford, Massachusetts, 01886, United States

Location

Excellent Vision

Portsmouth, New Hampshire, 03801, United States

Location

New Jersey Plastic Surgery

Montclair, New Jersey, 07042, United States

Location

Saluja Cosmetic and Laser Center

Huntersville, North Carolina, 28078, United States

Location

Institute of Female Pelvic Medicine

Knoxville, Tennessee, 37932, United States

Location

Related Publications (1)

  • Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.

    PMID: 31896400BACKGROUND

MeSH Terms

Conditions

Thrombosis

Interventions

Laser Therapy

Condition Hierarchy (Ancestors)

Embolism and ThrombosisVascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

TherapeuticsAblation TechniquesSurgical Procedures, Operative

Results Point of Contact

Title
Jamie Trimper
Organization
Cynosure
jamie.trimper@cynosure.com
800-886-2966

Study Officials

  • Jennifer Civiok

    Cynosure, Inc.

    STUDY DIRECTOR

  • Sean Doherty

    Cynosure, Inc.

    PRINCIPAL INVESTIGATOR

  • Raminder Saluja

    Saluja Cosmetic and Laser Center

    PRINCIPAL INVESTIGATOR

  • Barry DiBernardo

    New Jersey Plastic Surgery

    PRINCIPAL INVESTIGATOR

  • Edward Jaccoma

    Excellent Vision

    PRINCIPAL INVESTIGATOR

  • Jeffrey Dell

    Institute of Female Pelvic Medicine

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 8, 2021

First Posted

December 22, 2021

Study Start

January 18, 2017

Primary Completion

February 4, 2019

Study Completion

February 4, 2019

Last Updated

April 4, 2022

Results First Posted

April 4, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

Locations

US(5)