LipolysisNCT04881175
Histological Study on Safety and Efficacy of a RF Device Flexible Applicator for Non-Invasive Lipolysis
A study testing Non-Invasive Treatment in people with Lipolysis, run by Cynosure, Inc. at 2 sites in United States.
Trial summary
This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect efficacy data on the TempSure FlexSure applicator for fat lipolysis. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Lipolysis
- What is being tested?
- Non-Invasive Treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Feb 2021to 25 Feb 2021
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- A healthy male or female between the age of 18 - 55 years old.
- Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area.
- Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- Understands and accepts the obligation and is logistically able to be present for all visits.
- Is willing to comply with all requirements of the study and sign the informed consent document.
Who cannot join
- Is 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 a pregnancy during the study.
- The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
- The subject has a cut, wound, or infected skin on the area to be treated.
- The subject is on local, oral, or systemic anesthetic agents.
- The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
- The subject is currently enrolled in an investigational drug or device trial, or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months (or at the discretion of the Investigator) prior to entering this study.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
New Jersey Plastic Surgery
Montclair, New Jersey, 07042
Bass Plastic Surgery
New York, New York, 10065
About this study
Official title: Histological Study to Assess Safety and Efficacy of a Radiofrequency Device Flexible Applicator for Non-Invasive Lipolysis
This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect efficacy data on the TempSure FlexSure applicator for fat lipolysis.
Read the detailed description
Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments every 1-2 weeks on the abdomen or flanks.
- Conditions
- Lipolysis
- Being tested
- Non-Invasive Treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Invasive TreatmentDevice
Single-arm group using the FlexSure Applicator device.
| Study group | Role | What they receive |
|---|---|---|
| FlexSure Applicator | Experimental | The TempSure FlexSure applicator will be used on the abdomen or flanks. Receives: Device: Non-Invasive Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Count of Samples That Showed a Change in Adipocyte Necrosis After Treatment
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.
Measured: immediately post treatment (only 1 treatment was conducted)
Count of Samples That Showed an Inflammatory Immune Response Vs. Baseline
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.
Measured: Baseline, immediately post treatment (only 1 treatment was conducted)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2021
- Study start9 Feb 2021
- Primary completion25 Feb 2021
- Study completion25 Feb 2021
Why it stopped: The study was terminated because of a business decision.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for LipolysisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jennifer Civiok, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04881175
- Sponsor's protocol ID
- CYN20-FLEX-HISTO
- Status last verified
- May 2022
- First submitted
- 3 May 2021
- Last updated
- 31 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 31896400
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Histological Study to Assess Safety and Efficacy of a Radiofrequency Device Flexible Applicator for Non-Invasive Lipolysis
- ClinicalTrials.gov ID
- NCT04881175
- Acronym / sponsor ID
- CYN20-FLEX-HISTO
- Conditions
- Lipolysis
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated because of a business decision.
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 25 Feb 2021 (actual)
- Study completion
- 25 Feb 2021 (actual)
- First posted
- 11 May 2021 (actual)
- Results
- Posted 31 May 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, open-labeled, non-randomized, multi-center clinical study to collect efficacy data on the TempSure FlexSure applicator for fat lipolysis.
Detailed description
Subjects will attend a screening/pretreatment visit which may be performed on the same day as the treatment visit. Subjects may receive up to 5 treatments every 1-2 weeks on the abdomen or flanks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FlexSure Applicator | Experimental | Device: Non-Invasive TreatmentThe TempSure FlexSure applicator will be used on the abdomen or flanks. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A healthy male or female between the age of 18 - 55 years old.
- Willing to receive treatments with the TempSure device and are willing to have biopsies taken from a control site and the treatment area.
- Understands and accepts obligation not to receive any other procedures on the treatment area through the length of the study.
- Understands and accepts the obligation and is logistically able to be present for all visits.
- Is willing to comply with all requirements of the study and sign the informed consent document.
Key exclusion criteria (6 listed)
- Is 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 a pregnancy during the study.
- The subject is currently enrolled in an investigational drug or device trial or has received an investigational drug or been treated with an investigational device within in the area to be treated 6 months prior to entering this study.
- The subject has a cut, wound, or infected skin on the area to be treated.
- The subject is on local, oral, or systemic anesthetic agents.
- The subject has any condition or is in a situation which in the investigators opinion may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non-Invasive TreatmentSingle-arm group using the FlexSure Applicator device. | Device | FlexSure Applicator |
Primary outcome
Count of Samples That Showed a Change in Adipocyte Necrosis After Treatment
Time frame: 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.
Count of Samples That Showed an Inflammatory Immune Response Vs. Baseline
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 31896400Gupta 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jennifer Civiok study director
Cynosure, Inc.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Invasive Treatment in people with Lipolysis, run by Cynosure, Inc. at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 May 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Count of Samples That Showed a Change in Adipocyte Necrosis After Treatment (time frame: immediately post treatment (only 1 treatment was conducted)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04881175, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2022.