WrinkleNCT04930705
Study To Assess The Safety And Efficacy Of The Tempsure Flexsure Applicators For Abdominal Wrinkles
A study testing Treatment with TempSure Applicator in people with Wrinkle, run by Cynosure, Inc. at 1 site in United States.
Trial summary
Subjects will be enrolled at 1 study center. Subjects may receive 5 treatments with the TempSure® device on the abdomen for wrinkles. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Wrinkle
- What is being tested?
- Treatment with TempSure Applicator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 May 2021to 31 May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
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, non-smoking male or female between the age of 18 - 55 years old.
- Willing to receive treatments with the TempSure® device.
- Understand and accept obligation not to receive any other procedures on the treatment and control area throughout 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 child bearing 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 nerve insensitivity to heat in the treatment area.
- 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.
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- Cautionary Criteria:
- The subject has any embedded electronic device that gives or receives a signal, the device should be turned off or removed prior to treatment.
- The subject has an embedded pacemaker or implantable cardioverter defibrillator (ICD), the client's cardiologist must be consulted prior to treatment.
- NOTE: This device has not been tested on patients implanted with electronic devices that receive or emit signals, such as: Pacemakers, Implantable Cardiac Defibrillators (ICD), or Cardiac Resynchronization Therapy (CRT) devices.
- If the neutral pad would need to be placed on a subject that has a metal plate, rod, or any metal implant that could conduct heat from the Smart Handpiece or surgical handpiece.
- The subject is allergic to adhesives, such as glues on medical tape, they should be alerted that a rash may occur on the neutral pad site and an over the counter solution may be used to treat the area.
- If the subject has an unhealthy expectation of the results - this is not plastic surgery and all subject should be fully informed of the treatment's expected results.
- The subject has severe laxity or sagging that causes redundant folds of tissue or hanging skin in the area to be treated - this treatment will be ineffective.
- The subject has used Accutane (Isotretinoin) six to twelve months prior to treatment, as this can thin the skin and make it britlle
- Studies of the use of the RF generator on subjects that have any of the following conditions is unknown:
- Autoimmune Disease
- Diabetic
- Herpes Simplex
- Use caution when treating areas that have tattoos, permanent makeup, and permanent brows.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Clinical Study To Assess The Safety And Efficacy Of The Tempsure Flexsure Applicators For The Treatment Of Abdominal Wrinkles
Subjects will be enrolled at 1 study center. Subjects may receive 5 treatments with the TempSure® device on the abdomen for wrinkles.
- Conditions
- Wrinkle
- Being tested
- Treatment with TempSure Applicator
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treatment with TempSure ApplicatorDevice
Subjects will receive up to 5 treatments on the abdomen.
| Study group | Role | What they receive |
|---|---|---|
| TempSure FlexSure Applicator | Experimental | Subjects will be treated with the TempSure FlexSure applicator device at each treatment. Receives: Device: Treatment with TempSure Applicator |
What is being measured
The primary outcome is the main question the study is designed to answer.
Correct Identification of Pre-Treatment Images Compared to Follow Up Images
Blinded independent reviewers will be given pre-treatment and 30 day follow up images and will identify which image is pre-treatment, and which image was taken at the follow up. The percentage of correct images identified will be reported.
Measured: 30 Day Follow Up
Correct Identification of Pre-Treatment Images Compared to Follow Up Images
Blinded independent reviewers will be given pre-treatment and 90 day follow up images and will identify which image is pre-treatment, and which image was taken at the follow up. The percentage of correct images identified will be reported.
Measured: 90 Day Follow Up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2021
- Study start17 May 2021
- Primary completion31 May 2022
- Study completion31 May 2022
Why it stopped: This 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.
- Other trials for WrinkleStudies 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
- 15 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
- NCT04930705
- Sponsor's protocol ID
- 7027-PL01-2021
- Status last verified
- Oct 2022
- First submitted
- 11 Jun 2021
- Last updated
- 7 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study To Assess The Safety And Efficacy Of The Tempsure Flexsure Applicators For The Treatment Of Abdominal Wrinkles
- ClinicalTrials.gov ID
- NCT04930705
- Acronym / sponsor ID
- 7027-PL01-2021
- Conditions
- Wrinkle
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: This study was terminated because of a business decision.
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- 17 May 2021 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 31 May 2022 (actual)
- First posted
- 18 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Subjects will be enrolled at 1 study center. Subjects may receive 5 treatments with the TempSure® device on the abdomen for wrinkles.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TempSure FlexSure Applicator | Experimental | Device: Treatment with TempSure ApplicatorSubjects will be treated with the TempSure FlexSure applicator device at each treatment. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- A healthy, non-smoking male or female between the age of 18 - 55 years old.
- Willing to receive treatments with the TempSure® device.
- Understand and accept obligation not to receive any other procedures on the treatment and control area throughout 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 (20 listed)
- Is pregnant or of child bearing 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 nerve insensitivity to heat in the treatment area.
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 |
|---|---|---|
| Treatment with TempSure ApplicatorSubjects will receive up to 5 treatments on the abdomen. | Device | TempSure FlexSure Applicator |
Primary outcome
Correct Identification of Pre-Treatment Images Compared to Follow Up Images
Time frame: 30 Day Follow Up
Blinded independent reviewers will be given pre-treatment and 30 day follow up images and will identify which image is pre-treatment, and which image was taken at the follow up. The percentage of correct images identified will be reported.
Correct Identification of Pre-Treatment Images Compared to Follow Up Images
Time frame: 90 Day Follow Up
Blinded independent reviewers will be given pre-treatment and 90 day follow up images and will identify which image is pre-treatment, and which image was taken at the follow up. The percentage of correct images identified will be reported.
Results and safety
The study was stopped early (reason given: This study was terminated because of a business decision.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2022.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Treatment with TempSure Applicator in people with Wrinkle, run by Cynosure, Inc. at 1 site 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 20 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 7 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study was stopped early (reason given: This study was terminated because of a business decision.). Results are not available in the source record.
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?
Correct Identification of Pre-Treatment Images Compared to Follow Up Images (time frame: 30 Day Follow Up). 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?
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 7 Oct 2022.