Trial Outcomes & Findings for Multi-Center Traditional Feasibility Study of Radiofrequency Device (NCT NCT04584099)
NCT ID: NCT04584099
Last Updated: 2023-06-15
Results Overview
Samples will be assessed independently and may be assessed for normal structures, cell viability, vascular injury, and overall morphologic traits, injury, and any indications of the healing response.
TERMINATED
NA
12 participants
Up to 30 days post last treatment
2023-06-15
Participant Flow
Participant milestones
| Measure |
Biopsy Removed Post Tx
All subjects had one radiofrequency treatment before scheduled biopsy or abdominoplasty on tissue to be removed during abdominoplasty immediately post treatment, 10 days post treatment, 20 days post treatment, and/or 30 days post treatment.
Radiofrequency device treatment: TempSure firm
|
|---|---|
|
Overall Study
STARTED
|
12
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
12
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
2 subjects did not have their ages analyzed.
Baseline characteristics by cohort
| Measure |
Biopsy Removed Post Tx
n=12 Participants
All subjects had one radiofrequency treatment before scheduled biopsy or abdominoplasty on tissue to be removed during abdominoplasty immediately post treatment, 10 days post treatment, 20 days post treatment, and/or 30 days post treatment.
Radiofrequency device treatment: TempSure firm
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants • 2 subjects did not have their ages analyzed.
|
|
Age, Categorical
Between 18 and 65 years
|
10 Participants
n=10 Participants • 2 subjects did not have their ages analyzed.
|
|
Age, Categorical
>=65 years
|
0 Participants
n=10 Participants • 2 subjects did not have their ages analyzed.
|
|
Sex: Female, Male
Female
|
11 Participants
n=11 Participants • One subject did not report their sex.
|
|
Sex: Female, Male
Male
|
0 Participants
n=11 Participants • One subject did not report their sex.
|
|
Race/Ethnicity, Customized
African American
|
5 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
1 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
5 Participants
n=12 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=12 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
1 Participants
n=5 Participants • Only 5 subjects reported on their Fitzpatrick Skin Types.
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type II
|
0 Participants
n=5 Participants • Only 5 subjects reported on their Fitzpatrick Skin Types.
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
1 Participants
n=5 Participants • Only 5 subjects reported on their Fitzpatrick Skin Types.
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
0 Participants
n=5 Participants • Only 5 subjects reported on their Fitzpatrick Skin Types.
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
1 Participants
n=5 Participants • Only 5 subjects reported on their Fitzpatrick Skin Types.
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
2 Participants
n=5 Participants • Only 5 subjects reported on their Fitzpatrick Skin Types.
|
PRIMARY outcome
Timeframe: Up to 30 days post last treatmentPopulation: Data were not collected.
Samples will be assessed independently and may be assessed for normal structures, cell viability, vascular injury, and overall morphologic traits, injury, and any indications of the healing response.
Outcome measures
Outcome data not reported
Adverse Events
Biopsy Removed Post Tx
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
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