Trial Outcomes & Findings for Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks (NCT NCT04881149)
NCT ID: NCT04881149
Last Updated: 2022-06-01
Results Overview
Sections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of elastin. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of elastin (control compared to treatment) is reported.
COMPLETED
NA
7 participants
1 Week (7-10 days) Post Baseline
2022-06-01
Participant Flow
Unit of analysis: biopsy samples
Participant milestones
| Measure |
All Study Participants
The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment).
|
|---|---|
|
Overall Study
STARTED
|
7 14
|
|
Overall Study
Control Biopsy
|
7 7
|
|
Overall Study
Treatment Biopsy
|
7 7
|
|
Overall Study
COMPLETED
|
7 14
|
|
Overall Study
NOT COMPLETED
|
0 0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Rollover Study to Evaluate Histological Results of Radiofrequency Device Treatments on the Flanks
Baseline characteristics by cohort
| Measure |
TempSure Device
n=7 Participants
The TempSure will be used on the flanks during this study.
TempSure treatment: Self-controlled, single-arm study using the TempSure device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=39 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
7 Participants
n=39 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=39 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=39 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
2 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
African American
|
1 Participants
n=39 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
4 Participants
n=39 Participants
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type I
|
0 Participants
n=39 Participants
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type II
|
0 Participants
n=39 Participants
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type III
|
1 Participants
n=39 Participants
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type IV
|
4 Participants
n=39 Participants
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type V
|
1 Participants
n=39 Participants
|
|
FitzPatrick Skin Type
FitzPatrick Skin Type VI
|
1 Participants
n=39 Participants
|
PRIMARY outcome
Timeframe: 1 Week (7-10 days) Post BaselineSections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of elastin. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of elastin (control compared to treatment) is reported.
Outcome measures
| Measure |
All Study Participants
n=14 biopsy samples
The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment).
|
|---|---|
|
Number of Treatment Samples With Different Levels of Elastin When Compared to Baseline Samples From the Same Patient
|
0 biopsy samples
|
PRIMARY outcome
Timeframe: 1 Week (7-10 days) Post BaselineSections of skin were removed using the punch biopsy technique to render a microscopic diagnosis. Each specimen was preserved with a fixative and then stained using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green and/or nitroblue tetrazolium chloride (NBTC) staining methods. If using Hemotoxylin \& Eosin, Verhoeff and Masson Red/Fast Green staining, samples were assessed and evaluated by the amount of collagen. If using NBTC staining, samples were assessed and evaluated to differentiate between the blue-stained viable cells and the unstained thermally damaged cells. The samples were examined by a qualified pathologist. The visual changes between the treated samples and the control samples were examined, with no typical unit of measure used to quantify the difference. Simply, control and treatment images were compared to each other with a qualitative analysis of the changes. The number of samples with different levels of collagen (control compared to treatment) is reported.
Outcome measures
| Measure |
All Study Participants
n=14 biopsy samples
The TempSure will be used on the flanks during this study. Subjects will receive 1 biopsy in the treatment area on the flank. Subjects will also receive 1 biopsy sample on the contralateral side, where they did not receive treatment. Each subject had 1 control sample (tissue that was taken from an area where no treatment was received), and 1 treatment sample (tissue taken from an area that had been subjected to the treatment).
|
|---|---|
|
Number of Treatment Samples With Different Levels of Dermis Collagen When Compared to Baseline Samples Taken From the Same Patient
|
0 biopsy samples
|
Adverse Events
Treatment Flank
Control Flank
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment Flank
n=7 participants at risk
The TempSure was used on the flanks during this study. Subjects receive 1 biopsy in the treatment area on the flank. Each subject had 1 treatment sample (tissue taken from an area that had been subjected to the treatment).
|
Control Flank
n=7 participants at risk
Subjects receive 1 biopsy sample on the contralateral side, where they did not receive treatment.
|
|---|---|---|
|
Nervous system disorders
Pain/tenderness
|
14.3%
1/7 • All adverse events were followed through study completion, an average of 7 months.
|
0.00%
0/7 • All adverse events were followed through study completion, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Irritation
|
0.00%
0/7 • All adverse events were followed through study completion, an average of 7 months.
|
14.3%
1/7 • All adverse events were followed through study completion, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Scabbing
|
14.3%
1/7 • All adverse events were followed through study completion, an average of 7 months.
|
14.3%
1/7 • All adverse events were followed through study completion, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Bruising
|
28.6%
2/7 • All adverse events were followed through study completion, an average of 7 months.
|
14.3%
1/7 • All adverse events were followed through study completion, an average of 7 months.
|
|
Skin and subcutaneous tissue disorders
Itching
|
0.00%
0/7 • All adverse events were followed through study completion, an average of 7 months.
|
14.3%
1/7 • All adverse events were followed through study completion, an average of 7 months.
|
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