Trial Outcomes & Findings for Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive Lipolysis (NCT NCT04881175)
NCT ID: NCT04881175
Last Updated: 2022-05-31
Results Overview
Photographs of the histological samples before and after the treatment (only one treatment occurred) will be examined for adipocyte necrosis. Each specimen will first be preserved with a fixative and stained with Hematoxylin and eosin (H\&E stain). To determine whether or not the samples are expressing histological changes, a pathologist will look at the histology of each individual sample and record if they see any changes in histology post treatment vs. the histology taken at the baseline (these changes are observable to the eye). Then, the number of biopsy samples that express any change in adipocyte necrosis will be reported.
TERMINATED
NA
3 participants
immediately post treatment (only 1 treatment was conducted)
2022-05-31
Participant Flow
Participant milestones
| Measure |
FlexSure Applicator
The TempSure FlexSure applicator will be used on the abdomen or flanks.
Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device.
|
|---|---|
|
Overall Study
STARTED
|
3
|
|
Overall Study
COMPLETED
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive Lipolysis
Baseline characteristics by cohort
| Measure |
FlexSure Applicator
n=3 Participants
The TempSure FlexSure applicator will be used on the abdomen or flanks.
Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
3 Participants
n=99 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=99 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
African American
|
2 Participants
n=99 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
1 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
0 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
0Fitzpatrick Skin Type II
|
0 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
1 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
0 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
0 Participants
n=99 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
2 Participants
n=99 Participants
|
PRIMARY outcome
Timeframe: immediately post treatment (only 1 treatment was conducted)Photographs of the histological samples before and after the treatment (only one treatment occurred) will be examined for adipocyte necrosis. Each specimen will first be preserved with a fixative and stained with Hematoxylin and eosin (H\&E stain). To determine whether or not the samples are expressing histological changes, a pathologist will look at the histology of each individual sample and record if they see any changes in histology post treatment vs. the histology taken at the baseline (these changes are observable to the eye). Then, the number of biopsy samples that express any change in adipocyte necrosis will be reported.
Outcome measures
| Measure |
FlexSure Applicator
n=3 biopsy samples
The TempSure FlexSure applicator will be used on the abdomen or flanks.
Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device.
|
|---|---|
|
Count of Samples That Showed a Change in Adipocyte Necrosis After Treatment
|
0 biopsy samples
|
PRIMARY outcome
Timeframe: Baseline, immediately post treatment (only 1 treatment was conducted)Photographs of the histological samples before and after the last treatment will be examined for an inflammatory immune response. Each specimen will first be preserved with a fixative and stained with Hematoxylin and eosin (H\&E stain) To determine whether or not the samples are expressing histological changes, a pathologist will look at the histology of each individual sample and record if they see any changes in histology post treatment vs. the histology taken at the baseline (these changes are observable to the eye). Then, the number of biopsy samples that express any change in an inflammatory immune response will be reported.
Outcome measures
| Measure |
FlexSure Applicator
n=3 biopsy samples
The TempSure FlexSure applicator will be used on the abdomen or flanks.
Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device.
|
|---|---|
|
Count of Samples That Showed an Inflammatory Immune Response Vs. Baseline
|
0 biopsy samples
|
Adverse Events
FlexSure Applicator
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
FlexSure Applicator
n=3 participants at risk
The TempSure FlexSure applicator will be used on the abdomen or flanks.
Non-Invasive Treatment: Single-arm group using the FlexSure Applicator device.
|
|---|---|
|
Skin and subcutaneous tissue disorders
skin burn
|
66.7%
2/3 • Adverse events were tracked until subject completion of the study, approximately 2 weeks.
|
|
Skin and subcutaneous tissue disorders
erythema
|
66.7%
2/3 • Adverse events were tracked until subject completion of the study, approximately 2 weeks.
|
|
Skin and subcutaneous tissue disorders
pain/tenderness
|
66.7%
2/3 • Adverse events were tracked until subject completion of the study, approximately 2 weeks.
|
|
Skin and subcutaneous tissue disorders
nodule
|
66.7%
2/3 • Adverse events were tracked until subject completion of the study, approximately 2 weeks.
|
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