Tissue Heating, Coagulation
Conditions
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.
Interventions
Sponsors
Cynosure, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subject Satisfaction | 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 | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Surgical- Abdominoplasty Subjects enrolled in the surgical arm were treated with the device being placed in contact with the abdomen. The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.
TempSure: Radiofrequency platform
Scalpel: Cold knife
Bovie: Electrosurgery and electrocautery platform | 0 |
| Women's Health Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.
TempSure: Radiofrequency platform | 10 |
| Skin Rejuvenation 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.
TempSure: Radiofrequency platform
Pelleve: Radiofrequency platform | 68 |
| Surgical- Blepharoplasty Subjects enrolled in the surgical arm were treated with the device being placed in contact with the eye area The hand piece, number of passes and parameters used for the treatment were determined by the Investigator.
TempSure: Radiofrequency platform
Scalpel: Cold knife
Bovie: Electrosurgery and electrocautery platform | 10 |
| Total | 88 |
Baseline characteristics
| Characteristic | Women's Health | Skin Rejuvenation | Surgical- Blepharoplasty | Total | Surgical- Abdominoplasty |
|---|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants | — |
| Age, Categorical >=65 years | 1 Participants | 4 Participants | 1 Participants | 6 Participants | — |
| Age, Categorical Between 18 and 65 years | 9 Participants | 64 Participants | 9 Participants | 82 Participants | — |
| FitzPatrick Skin Type FitzPatrick Skin Type I | — | 1 Participants | 0 Participants | 1 Participants | — |
| FitzPatrick Skin Type FitzPatrick Skin Type II | — | 26 Participants | 1 Participants | 27 Participants | — |
| FitzPatrick Skin Type FitzPatrick Skin Type III | — | 33 Participants | 9 Participants | 42 Participants | — |
| FitzPatrick Skin Type FitzPatrick Skin Type IV | — | 4 Participants | 0 Participants | 4 Participants | — |
| FitzPatrick Skin Type FitzPatrick Skin Type V | — | 0 Participants | 0 Participants | 0 Participants | — |
| FitzPatrick Skin Type FitzPatrick Skin Type VI | — | 2 Participants | 0 Participants | 2 Participants | — |
| Race/Ethnicity, Customized African American | 0 Participants | 2 Participants | 0 Participants | 2 Participants | — |
| Race/Ethnicity, Customized Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants | — |
| Race/Ethnicity, Customized Caucasian | 10 Participants | 60 Participants | 8 Participants | 78 Participants | — |
| Race/Ethnicity, Customized Hispanic | 0 Participants | 4 Participants | 1 Participants | 5 Participants | — |
| Race/Ethnicity, Customized Other (Unspecified) | 0 Participants | 0 Participants | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 10 Participants | 61 Participants | 9 Participants | 80 Participants | — |
| Sex: Female, Male Male | 0 Participants | 6 Participants | 1 Participants | 7 Participants | — |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 1 | 0 / 10 | 0 / 68 | 0 / 10 |
| other Total, other adverse events | 0 / 1 | 0 / 11 | 39 / 68 | 9 / 10 |
| serious Total, serious adverse events | 0 / 1 | 0 / 10 | 0 / 68 | 0 / 10 |
Outcome results
Primary
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.
Time frame: Immediately Post Treatment (Same Day)
Population: The other arms of the study did not undergo abdominoplasties or have biopsies taken. Therefore, they do not have results for this outcome measure.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Women's Health | Number of Tissue Samples With Successful Results | 20 samples of abdominoplasty |
Primary
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.
Time frame: 30 days post final treatment
Population: 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.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Women's Health | Subject Satisfaction | Satisfied | 2 Participants |
| Women's Health | Subject Satisfaction | Extremely Satisfied | 0 Participants |
| Women's Health | Subject Satisfaction | Slightly Satisfied | 4 Participants |
| Women's Health | Subject Satisfaction | Dissatisfied | 2 Participants |
| Women's Health | Subject Satisfaction | Slightly Dissatisfied | 2 Participants |
| Women's Health | Subject Satisfaction | Extremely Dissatisfied | 0 Participants |
| Skin Rejuvenation | Subject Satisfaction | Slightly Dissatisfied | 1 Participants |
| Skin Rejuvenation | Subject Satisfaction | Dissatisfied | 4 Participants |
| Skin Rejuvenation | Subject Satisfaction | Extremely Dissatisfied | 2 Participants |
| Skin Rejuvenation | Subject Satisfaction | Satisfied | 14 Participants |
| Skin Rejuvenation | Subject Satisfaction | Extremely Satisfied | 6 Participants |
| Skin Rejuvenation | Subject Satisfaction | Slightly Satisfied | 11 Participants |
| Surgical- Blepharoplasty | Subject Satisfaction | Extremely Dissatisfied | 0 Participants |
| Surgical- Blepharoplasty | Subject Satisfaction | Extremely Satisfied | 4 Participants |
| Surgical- Blepharoplasty | Subject Satisfaction | Satisfied | 5 Participants |
| Surgical- Blepharoplasty | Subject Satisfaction | Slightly Satisfied | 1 Participants |
| Surgical- Blepharoplasty | Subject Satisfaction | Slightly Dissatisfied | 0 Participants |
| Surgical- Blepharoplasty | Subject Satisfaction | Dissatisfied | 0 Participants |