- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04878172
Histological Study to Assess Safety and Efficacy of the TempSure Firm for Non-Invasive Lipolysis
April 20, 2022 updated by: Cynosure, Inc.
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.
Study Overview
Detailed Description
Up to 12 subjects will be enrolled at up to 3 study centers.
Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit.
Subjects may receive 1 treatment on the abdomen with the TempSure firm.
Subjects will undergo abdominoplasty surgery at one of 4 predetermined timepoint after an abdomen treatment: day 0 (within 24 hours after treatment), 10 days (+/- 3 days), 20 days (+/- 3 days), or 30 days (+/- 7 days).
This will be determined by the availability of the subject and/or an as needed basis and this will be decided by the Investigator and the Sponsor.
Study Type
Interventional
Enrollment (Actual)
9
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10065
- Bass Plastic Surgery PLLC
-
Staten Island, New York, United States, 10306
- Aesthetic Pavilion Ambulatory Surgery Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Male or female between 18 - 55 years old.
- Willing to receive treatments with the TempSure® device and willing to have biopsies taken from a control site and the treatment area (biopsies are collected after the abdominal tissue flap is removed during abdominoplasty surgery)
- Understand and accept obligation not to receive any other procedures on the treatment and control areas throughout the length of the study.
- Understand and accept the obligation and able to be present for all study visits
- Willing to comply with all requirements of the study and able to provide informed consent.
Exclusion Criteria:
Pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, currently breast feeding or planning to become pregnant prior to the end of the study.
- Currently enrolled in an investigational drug or device trial, or has received an investigational drug or investigational device treatment(s) in the area to be treated (or designated control area) 6 months prior to entering this study (or at the discretion of the Investigator) .
- Cuts, wounds, or infected skin on the area to be treated or designated control area
- On local, oral, or systemic anesthetic agents.
- Condition(s) or circumstance(s) that, in the investigators opinion, may put the subject at significant risk, may confound study results or may interfere significantly with subject participation.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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).
|
The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
Experimental: 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.
|
The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
Experimental: 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.
|
The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
Experimental: 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.
|
The TempSure firm will be used on the abdomen for non-invasive lipolysis.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Histology of Biopsy
Time Frame: within 24 hours post treatment
|
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
Time Frame: within 10 days (+/- 3 days) post treatment
|
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
Time Frame: within 20 days (+/- 3 days) post treatment
|
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
Time Frame: within 30 days (+/- 7 days) post treatment
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Jennifer Civiok, Cynosure, Inc.
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 12, 2021
Primary Completion (Actual)
September 28, 2021
Study Completion (Actual)
September 28, 2021
Study Registration Dates
First Submitted
May 4, 2021
First Submitted That Met QC Criteria
May 4, 2021
First Posted (Actual)
May 7, 2021
Study Record Updates
Last Update Posted (Actual)
April 21, 2022
Last Update Submitted That Met QC Criteria
April 20, 2022
Last Verified
April 1, 2022
More Information
Terms related to this study
Other Study ID Numbers
- 7027-MCPL-2021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
Yes
product manufactured in and exported from the U.S.
Yes
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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