Trial Outcomes & Findings for Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis (NCT NCT04878172)
NCT ID: NCT04878172
Last Updated: 2022-04-21
Results Overview
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm within 24 hours post treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist).
COMPLETED
NA
9 participants
within 24 hours post treatment
2022-04-21
Participant Flow
Participant milestones
| Measure |
TempSure Firm Day 0 Biopsy Group
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
TempSure Firm Day 10 Biopsy Group
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment.
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
TempSure Firm Day 20 Biopsy Group
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment.
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
TempSure Firm Day 30 Biopsy Group
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment.
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
2
|
2
|
3
|
|
Overall Study
COMPLETED
|
2
|
2
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis
Baseline characteristics by cohort
| Measure |
TempSure Firm Day 0 Biopsy Group
n=2 Participants
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
TempSure Firm Day 10 Biopsy Group
n=2 Participants
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment.
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
TempSure Firm Day 20 Biopsy Group
n=2 Participants
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment.
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
TempSure Firm Day 30 Biopsy Group
n=3 Participants
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment.
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
Total
n=9 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=31 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
3 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
African American
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
8 Participants
n=31 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type I
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type II
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type III
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=31 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type IV
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type V
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=31 Participants
|
|
FitzPatrick Skin Type
Fitzpatrick Skin Type VI
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: within 24 hours post treatmentSubjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm within 24 hours post treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist).
Outcome measures
| Measure |
TempSure Firm Day 0 Biopsy Group
n=2 Participants
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
|---|---|
|
Histology of Biopsy
# of participants whose sample had signs of adipocyte injury and/or inflammatory tissue response.
|
2 Participants
|
|
Histology of Biopsy
# of participants whose sample had no epidermal or dermal tissue injury
|
2 Participants
|
PRIMARY outcome
Timeframe: within 10 days (+/- 3 days) post treatmentSubjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist).
Outcome measures
| Measure |
TempSure Firm Day 0 Biopsy Group
n=2 Participants
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
|---|---|
|
Histology of Biopsy
# of participants whose sample had signs of adipocyte injury and/or inflammatory tissue response.
|
2 participants
|
|
Histology of Biopsy
# of participants whose sample had no epidermal or dermal tissue injury
|
2 participants
|
PRIMARY outcome
Timeframe: within 20 days (+/- 3 days) post treatmentSubjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist).
Outcome measures
| Measure |
TempSure Firm Day 0 Biopsy Group
n=2 Participants
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
|---|---|
|
Histology of Biopsy
# of participants whose sample had signs of adipocyte injury and/or inflammatory tissue response.
|
2 participants
|
|
Histology of Biopsy
# of participants whose sample had no epidermal or dermal tissue injury
|
2 participants
|
PRIMARY outcome
Timeframe: within 30 days (+/- 7 days) post treatmentSubjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 3 days) after treatment. The samples were looked at from a qualitative standpoint to determine of whether the samples had signs of adipocyte injury and/or inflammatory tissue response, and if there was dermal/epidermal tissue injury (which was assessed by a qualified histologist).
Outcome measures
| Measure |
TempSure Firm Day 0 Biopsy Group
n=3 Participants
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).
TempSure Firm: The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
|---|---|
|
Histology of Biopsy
# of participants whose sample had signs of adipocyte injury and/or inflammatory tissue response.
|
3 participants
|
|
Histology of Biopsy
# of participants whose sample had no epidermal or dermal tissue injury
|
3 participants
|
Adverse Events
TempSure Firm Day 0 Biopsy Group
TempSure Firm Day 10 Biopsy Group
TempSure Firm Day 20 Biopsy Group
TempSure Firm Day 30 Biopsy Group
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