Trial Outcomes & Findings for Clinical Study To Assess The Safety, Parameters And Efficacy For Procedures Using A Radiofrequency Device (NCT NCT05166824)
NCT ID: NCT05166824
Last Updated: 2022-04-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
89 participants
Primary outcome timeframe
30 days post final treatment
Results posted on
2022-04-04
Participant Flow
Participant milestones
| Measure |
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.
|
Women's Health
Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.
|
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.
|
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.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
1
|
10
|
68
|
10
|
|
Overall Study
COMPLETED
|
1
|
10
|
59
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
9
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
The baseline sex of one of the subjects was not collected.
Baseline characteristics by cohort
| Measure |
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
|
Women's Health
n=10 Participants
Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.
TempSure: Radiofrequency platform
|
Skin Rejuvenation
n=68 Participants
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
|
Surgical- Blepharoplasty
n=10 Participants
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
|
Total
n=88 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
—
|
0 Participants
n=10 Participants
|
0 Participants
n=68 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=88 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
—
|
9 Participants
n=10 Participants
|
64 Participants
n=68 Participants
|
9 Participants
n=10 Participants
|
82 Participants
n=88 Participants
|
|
Age, Categorical
>=65 years
|
—
|
1 Participants
n=10 Participants
|
4 Participants
n=68 Participants
|
1 Participants
n=10 Participants
|
6 Participants
n=88 Participants
|
|
Sex: Female, Male
Female
|
—
|
10 Participants
n=10 Participants • The baseline sex of one of the subjects was not collected.
|
61 Participants
n=67 Participants • The baseline sex of one of the subjects was not collected.
|
9 Participants
n=10 Participants • The baseline sex of one of the subjects was not collected.
|
80 Participants
n=87 Participants • The baseline sex of one of the subjects was not collected.
|
|
Sex: Female, Male
Male
|
—
|
0 Participants
n=10 Participants • The baseline sex of one of the subjects was not collected.
|
6 Participants
n=67 Participants • The baseline sex of one of the subjects was not collected.
|
1 Participants
n=10 Participants • The baseline sex of one of the subjects was not collected.
|
7 Participants
n=87 Participants • The baseline sex of one of the subjects was not collected.
|
|
Race/Ethnicity, Customized
Caucasian
|
—
|
10 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
60 Participants
n=67 Participants • One subject did not have their race/ethnicity collected.
|
8 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
78 Participants
n=87 Participants • One subject did not have their race/ethnicity collected.
|
|
Race/Ethnicity, Customized
Asian
|
—
|
0 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
1 Participants
n=67 Participants • One subject did not have their race/ethnicity collected.
|
0 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
1 Participants
n=87 Participants • One subject did not have their race/ethnicity collected.
|
|
Race/Ethnicity, Customized
Hispanic
|
—
|
0 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
4 Participants
n=67 Participants • One subject did not have their race/ethnicity collected.
|
1 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
5 Participants
n=87 Participants • One subject did not have their race/ethnicity collected.
|
|
Race/Ethnicity, Customized
African American
|
—
|
0 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
2 Participants
n=67 Participants • One subject did not have their race/ethnicity collected.
|
0 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
2 Participants
n=87 Participants • One subject did not have their race/ethnicity collected.
|
|
Race/Ethnicity, Customized
Other (Unspecified)
|
0 Participants
One subject did not have their race/ethnicity collected.
|
0 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
0 Participants
n=67 Participants • One subject did not have their race/ethnicity collected.
|
1 Participants
n=10 Participants • One subject did not have their race/ethnicity collected.
|
1 Participants
n=87 Participants • One subject did not have their race/ethnicity collected.
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type I
|
—
|
—
|
1 Participants
n=66 Participants • 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.
|
0 Participants
n=10 Participants • 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.
|
1 Participants
n=76 Participants • 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.
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type II
|
—
|
—
|
26 Participants
n=66 Participants • 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.
|
1 Participants
n=10 Participants • 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.
|
27 Participants
n=76 Participants • 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.
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type III
|
—
|
—
|
33 Participants
n=66 Participants • 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.
|
9 Participants
n=10 Participants • 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.
|
42 Participants
n=76 Participants • 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.
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type IV
|
—
|
—
|
4 Participants
n=66 Participants • 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.
|
0 Participants
n=10 Participants • 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.
|
4 Participants
n=76 Participants • 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.
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type V
|
—
|
—
|
0 Participants
n=66 Participants • 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.
|
0 Participants
n=10 Participants • 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.
|
0 Participants
n=76 Participants • 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.
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type VI
|
—
|
—
|
2 Participants
n=66 Participants • 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.
|
0 Participants
n=10 Participants • 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.
|
2 Participants
n=76 Participants • 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.
|
PRIMARY outcome
Timeframe: 30 days post final treatmentPopulation: 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.
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.
Outcome measures
| Measure |
Women's Health
n=10 Participants
Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.
TempSure: Radiofrequency platform
|
Skin Rejuvenation
n=38 Participants
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
|
Surgical- Blepharoplasty
n=10 Participants
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.
|
|---|---|---|---|
|
Subject Satisfaction
Extremely Satisfied
|
0 Participants
|
6 Participants
|
4 Participants
|
|
Subject Satisfaction
Satisfied
|
2 Participants
|
14 Participants
|
5 Participants
|
|
Subject Satisfaction
Slightly Satisfied
|
4 Participants
|
11 Participants
|
1 Participants
|
|
Subject Satisfaction
Slightly Dissatisfied
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Subject Satisfaction
Dissatisfied
|
2 Participants
|
4 Participants
|
0 Participants
|
|
Subject Satisfaction
Extremely Dissatisfied
|
0 Participants
|
2 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Women's Health
n=1 Participants
Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.
TempSure: Radiofrequency platform
|
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
|
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.
|
|---|---|---|---|
|
Number of Tissue Samples With Successful Results
|
20 samples of abdominoplasty
|
—
|
—
|
Adverse Events
Surgical- Abdominoplasty
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Women's Health
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Skin Rejuvenation
Serious events: 0 serious events
Other events: 39 other events
Deaths: 0 deaths
Surgical- Blepharoplasty
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Surgical- Abdominoplasty
n=1 participants at risk
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
|
Women's Health
n=11 participants at risk；n=10 participants at risk
Subjects enrolled in the women's health were treated with the device in the vaginal and perineal area.
TempSure: Radiofrequency platform
|
Skin Rejuvenation
n=68 participants at risk
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
|
Surgical- Blepharoplasty
n=10 participants at risk
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
|
|---|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
35.3%
24/68 • 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.
|
90.0%
9/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Edema
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
44.1%
30/68 • 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.
|
90.0%
9/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Skin Burn
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
1.5%
1/68 • 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.
|
0.00%
0/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Bleeding
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/68 • 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.
|
60.0%
6/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/68 • 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.
|
80.0%
8/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Crusting
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/68 • 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.
|
40.0%
4/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Hardness
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/68 • 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.
|
20.0%
2/10 • 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.
|
|
Infections and infestations
Infection
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/68 • 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.
|
10.0%
1/10 • 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.
|
|
Skin and subcutaneous tissue disorders
Blistering
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/68 • 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.
|
10.0%
1/10 • 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.
|
|
Respiratory, thoracic and mediastinal disorders
Bruisiing
|
0.00%
0/1 • 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.
|
0.00%
0/11 • 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.
|
0.00%
0/68 • 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.
|
80.0%
8/10 • 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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI cannot disclose confidential or proprietary information until after it becomes generally known or available to the public.
- Publication restrictions are in place
Restriction type: OTHER