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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Women's Health | Experimental | Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area. |
|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TempSure | Device | Radiofrequency platform |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cynosure | Westford | Massachusetts | 01886 | United States | ||
| Excellent Vision |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31896400 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | Surgical- Abdominoplasty | 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. |
| FG001 | Women's Health | Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area. |
| FG002 | 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. |
| FG003 | Surgical- Blepharoplasty | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Baseline demographic information was not collected for the 1 subject in the surgical-abdominoplasty group.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | 30 days post final treatment |
|
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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Erythema | Skin and subcutaneous tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jamie Trimper | Cynosure | 800-886-2966 | jamie.trimper@cynosure.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 20, 2019 | Feb 14, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D013927 | Thrombosis |
| ID | Term |
|---|---|
| D016769 | Embolism and Thrombosis |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D053685 | Laser Therapy |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
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| Scalpel | Device | Cold knife |
|
| Bovie | Device | Electrosurgery and electrocautery platform |
|
| Pelleve | Device | Radiofrequency platform |
|
| Portsmouth |
| New Hampshire |
| 03801 |
| United States |
| New Jersey Plastic Surgery | Montclair | New Jersey | 07042 | United States |
| Saluja Cosmetic and Laser Center | Huntersville | North Carolina | 28078 | United States |
| Institute of Female Pelvic Medicine | Knoxville | Tennessee | 37932 | United States |
| BG001 |
| Women's Health |
Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area. TempSure: Radiofrequency platform |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | The baseline sex of one of the subjects was not collected. | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | One subject did not have their race/ethnicity collected. | Count of Participants | Participants |
|
| FitzPatrick Skin Type | The Fitzpatrick Skin Score is used to determine skin color. It is a numerical system that classifies skin into six types (Type I, Type II, Type III, Type IV, Type V and Type VI) based on the numerical score achieved (ranging from 0 to 36). The lower the score (and skin type number), the fairer the skin. The higher the score (and skin type number), the more deeply pigmented the skin is. The source for this article is cited in the references section. | FitzPatrick Skin Type was not taken for the women's health group because it was not applicable. Additionally, 2 subjects did not have their FitzPatrick Skin Type information collected. | Count of Participants | Participants |
|
| OG001 | 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 |
| OG002 | Surgical- Blepharoplasty | 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. |
|
|
| 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. | The other arms of the study did not undergo abdominoplasties or have biopsies taken. Therefore, they do not have results for this outcome measure. | Posted | Number | samples of abdominoplasty | Immediately Post Treatment (Same Day) |
|
|
|
| 0 |
| 1 |
| 0 |
| 1 |
| 0 |
| 1 |
| EG001 | Women's Health | Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area. TempSure: Radiofrequency platform | 0 | 10 | 0 | 10 | 0 | 11 |
| EG002 | 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 | 0 | 68 | 0 | 68 | 39 | 68 |
| EG003 | Surgical- Blepharoplasty | Subjects enrolled in the surgical arm were treated with the device being placed in contact with the eyelids. 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 | 10 | 0 | 10 | 9 | 10 |
| Edema | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Skin Burn | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bleeding | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Itching | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Crusting | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Hardness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Infection | Infections and infestations | Systematic Assessment |
|
| Blistering | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bruisiing | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
| Between 18 and 65 years |
|
| >=65 years |
|
| Male |
|
|
|
|
|
| FitzPatrick Skin Type III |
|
| FitzPatrick Skin Type IV |
|
| FitzPatrick Skin Type V |
|
| FitzPatrick Skin Type VI |
|