NCT04878172|CompletedResultsFDA Device
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Sponsor study identifier
interventional
9
1 country
2
Study Start
March 12, 2021
Actual (reported)Primary Completion
September 28, 2021
Actual (reported)Study Completion
September 28, 2021
Actual (reported)This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect safety and efficacy data on the TempSure Firm. The intended use of the TempSure device is to use the Firm handpieces for non-invasive lipolysis.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 28, 2021
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
March 12, 2021
Actual (reported)May 4, 2021
Actual (reported)May 7, 2021
Actual (reported)September 28, 2021
Actual (reported)September 28, 2021
Actual (reported)April 21, 2022
Actual (reported)Histology of Biopsy
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).
within 24 hours post treatment
Histology of Biopsy
Subjects 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).
within 10 days (+/- 3 days) post treatment
Histology of Biopsy
Subjects 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).
within 20 days (+/- 3 days) post treatment
Histology of Biopsy
Subjects 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).
within 30 days (+/- 7 days) post treatment
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 0 (within 24 hours after treatment).
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 10 (+/- 3 days) after treatment.
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 20 (+/- 3 days) after treatment.
The TempSure firm will be used on the abdomen for non-invasive lipolysis.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Bass Plastic Surgery PLLC
New York, New York, 10065, United States
Aesthetic Pavilion Ambulatory Surgery Center
Staten Island, New York, 10306, United States
Gupta V, Sharma VK. Skin typing: Fitzpatrick grading and others. Clin Dermatol. 2019 Sep-Oct;37(5):430-436. doi: 10.1016/j.clindermatol.2019.07.010. Epub 2019 Jul 17.
Jennifer Civiok
Cynosure, Inc.
9 participants (actual enrollment reported by the registry).
First Submitted
May 4, 2021
First Posted
May 7, 2021
Study Start
March 12, 2021
Subjects will undergo abdominal surgery after an abdominal treatment with TempSure Firm at day 30 (+/- 7 days) after treatment.
Contact the study team to confirm eligibility.
Primary Completion
September 28, 2021
Actual (reported)Study Completion
September 28, 2021
Actual (reported)Last Updated
April 21, 2022
Results First Posted
April 21, 2022
Record last verified: 2022-04
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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