Tissue HeatingNCT05166824

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

A study testing TempSure, Scalpel and Bovie in people with Tissue Heating and Coagulation, run by Cynosure, Inc. at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for: Tissue Heating, Coagulation
What is being tested?: TempSure, Scalpel and Bovie
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 89 participants
Where: 5 sitesUnited States
Study dates: 18 Jan 2017to 4 Feb 2019
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 9Show fewer

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.

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Saluja Cosmetic and Laser Center
Huntersville, North Carolina, 28078
Institute of Female Pelvic Medicine
Knoxville, Tennessee, 37932
New Jersey Plastic Surgery
Montclair, New Jersey, 07042
Excellent Vision
Portsmouth, New Hampshire, 03801
Cynosure
Westford, Massachusetts, 01886

Other trials in United States

About this study

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
Being tested: TempSure, Scalpel, Bovie, Pelleve
Medical subject headings: Thrombosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TempSureDevice
Radiofrequency platform
ScalpelDevice
Cold knife
BovieDevice
Electrosurgery and electrocautery platform
PelleveDevice
Radiofrequency platform

Study groups in NCT05166824
Study group	Role	What they receive
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. Receives: Device: TempSure; Device: Scalpel; Device: Bovie
Women's Health	Experimental	Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area. Receives: 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. Receives: Device: TempSure; Device: 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. Receives: Device: TempSure

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: Immediately Post Treatment (Same Day)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Jan 20174 Feb 2019

First posted22 Dec 2021
Study start18 Jan 2017
Primary completion4 Feb 2019
Study completion4 Feb 2019

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Tissue HeatingStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 89 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05166824
Sponsor's protocol ID: CYN17-RF-CLINIC
Status last verified: Mar 2022
First submitted: 8 Dec 2021
Last updated: 4 Apr 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: No

Publications

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.
PubMed 31896400

Study at a glance

From the registry record, last updated by the sponsor on 4 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device
ClinicalTrials.gov ID: NCT05166824
Acronym / sponsor ID: CYN17-RF-CLINIC
Conditions: Tissue Heating, Coagulation
Study type: Interventional
Recruitment status: Completed
Enrolment: 89 participants (actual)
Lead sponsor: Cynosure, Inc.Industry (pharma, biotech, devices)
Study start: 18 Jan 2017 (actual)
Primary completion: 4 Feb 2019 (actual)
Study completion: 4 Feb 2019 (actual)
First posted: 22 Dec 2021 (actual)
Results: Posted 4 Apr 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

Study design

Primary purpose: Treatment
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Surgical- abdominoplasty	Experimental	Device: TempSure, Device: Scalpel, Device: BovieSubjects 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.
Women's Health	Experimental	Device: TempSureSubjects enrolled in the women's health were treated with the device in the vaginal and perineal area.
Skin Rejuvenation	Experimental	Device: TempSure, Device: PelleveThe 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.
Surgical- blepharoplasty	Experimental	Device: TempSureSubjects 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.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TempSureRadiofrequency platform	Device	Skin Rejuvenation, Surgical- abdominoplasty, Surgical- blepharoplasty, Women's Health
ScalpelCold knife	Device	Surgical- abdominoplasty
BovieElectrosurgery and electrocautery platform	Device	Surgical- abdominoplasty
PelleveRadiofrequency platform	Device	Skin Rejuvenation

Primary outcome

Subject Satisfaction
Time frame: 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.
Number of Tissue Samples With Successful Results
Time frame: 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.

Results and safety

Results posted to the registry on 4 Apr 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Surgical- Abdominoplasty	1	1
Women's Health	10	10
Skin Rejuvenation	68	59
Surgical- Blepharoplasty	10	10

Primary outcome: Subject Satisfaction

Time frame: 30 days post final treatment. Count of participants. Unit: Participants

Measure	Women's Health n = 10	Skin Rejuvenation n = 38	Surgical- Blepharoplasty n = 10
Extremely Satisfied	0	6	4
Satisfied	2	14	5
Slightly Satisfied	4	11	1
Slightly Dissatisfied	2	1	0
Dissatisfied	2	4	0
Extremely Dissatisfied	0	2	0

Population analysed: Some subjects did not complete their 30 day follow up because they withdrew from the study (not because of any serious adverse events), they were lost to follow up, or they could not attend. The subject in the surgical group (abdominoplasty) was not required to complete subject satisfaction, since their participation was for histology purposes only.

Primary outcome: Number of Tissue Samples With Successful Results

Time frame: Immediately Post Treatment (Same Day). Number. Unit: samples of abdominoplasty

Measure	Surgical- Abdominoplasty n = 1
Value	20

Population analysed: The other arms of the study did not undergo abdominoplasties or have biopsies taken. Therefore, they do not have results for this outcome measure.

Adverse events

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.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Surgical- Abdominoplasty	0 of 1 (0%)	0 of 1 (0%)	0 of 1
Women's Health	0 of 10 (0%)	0 of 11 (0%)	0 of 10
Skin Rejuvenation	0 of 68 (0%)	39 of 68 (57.4%)	0 of 68
Surgical- Blepharoplasty	0 of 10 (0%)	9 of 10 (90%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Apr 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 31896400Gupta 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jennifer Civiok study director

Cynosure, Inc.

Sean Doherty principal investigator

Cynosure, Inc.

Raminder Saluja principal investigator

Saluja Cosmetic and Laser Center

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing TempSure, Scalpel and Bovie in people with Tissue Heating and Coagulation, run by Cynosure, Inc. at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Apr 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Subject Satisfaction (time frame: 30 days post final treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05166824, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Apr 2022.