Subcutaneous FatNCT02098811
Evaluation of the Safety and Precursors of Efficacy
A study testing 1064nm Laser and 940nm Laser in people with Subcutaneous Fat, run by Cynosure, Inc. at 1 site in United States.
Trial summary
The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening. Read more about this study
- Who is it for?
- Ages 20 to 55 years
- Conditions the study is for
- Subcutaneous Fat
- What is being tested?
- 1064nm Laser and 940nm Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2013to May 2014
- 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 20 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Non-smoking subjects between ages of 20-55 years of age presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
- Subjects (Group 2 and 3) who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
- Understand and accept the obligation associated with the procedure
- Subjects with Fitzpatrick skin types I to VI.
- Subjects (Group 2 and 3) who are willing to consent to participate in the study will be asked to undergo treatment, elasticity and ultrasound measurements, as outlined for each group and defined in section 6.0.
- Subjects must agree to maintain the same diet and exercise regime throughout the study
Who cannot join
- Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
- A history of allergic reactions to medications or anesthesia required for the procedure
- A history of thrombophlebitis
- A history of acute infections
- A history of heart failure
- Received or is anticipated to receive antiplatelets, anticoagulants, thrombolytics, vitamin E or anti-inflammatories within 2 weeks pre treatment
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- Intolerance to anesthesia or medications to be prescribed before or after the procedure.
- Any medical condition, that, in the investigator's opinion would interfere with the patient's participation in the study
- Taking medications that are photosensitive
- A history of keloid formation
- A study subject must not be pregnant or have been pregnant in the last 3 months
- The physician has the right to make determination of eligibility as he/she determines based on the standard of care
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Safety and Efficacy of a Non-Invasive Disruption of Fat and Skin Tightening Using 1064nm and 940nm Wavelengths
The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.
Read the detailed description
The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.
- Conditions
- Subcutaneous Fat
- Being tested
- 1064nm Laser, 940nm Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
1064nm LaserDevice
Patient will be treated with 1064nm Laser prior to abdominoplasty
940nm LaserDevice
Patient will be treated with 940nm Laser prior to abdominoplasty
| Study group | Role | What they receive |
|---|---|---|
| 1064nm laser Treatment Before Abdominoplasty | Experimental | Patient will be treated with 1064nm Laser prior to abdominoplasty Receives: Device: 1064nm Laser |
| 940nm Laser Treatment Before Abdominoplasty | Experimental | Patient will be treated with 940nm Laser prior to abdominoplasty Receives: Device: 940nm Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biopsy of Tissue Sample as a Measure of Effectiveness
Biopsy of treated area will be obtained up to 6 months post treatment and will be histologically assessed for changes in adipocytes, collagen and surrounding tissue to determine effectiveness of device
Measured: 6 months post treatment
Ultrasound Measurement to Evaluate Reduction of Fat
Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine reduction of fat
Measured: 6 months post treatment
Secondary outcomes (1)
High Frequency Ultrasound to Measure Skin Elasticity and Thickness
High frequency ultrasound of the treatment area will be performed and evaluated in comparison to baseline results to measure changes in skin elasticity and skin thickness.
Measured: 6 months post last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2014 (estimated)
- Study startJun 2013
- Primary completionMay 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subcutaneous FatStudies 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cynosure, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Patric Krantz, Study director, Cynosure, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098811
- Sponsor's protocol ID
- CYN13-NIF-JD-04
- Status last verified
- Oct 2020
- First submitted
- 25 Mar 2014
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Safety and Efficacy of a Non-Invasive Disruption of Fat and Skin Tightening Using 1064nm and 940nm Wavelengths
- ClinicalTrials.gov ID
- NCT02098811
- Acronym / sponsor ID
- CYN13-NIF-JD-04
- Conditions
- Subcutaneous Fat
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Cynosure, Inc.Industry (pharma, biotech, devices)
- Study start
- Jun 2013
- Primary completion
- May 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 28 Mar 2014 (estimated)
- 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.
The purpose of this study is to evaluate and compare the safety and pre-cursors of efficacy of a non-invasive 1064nm laser and 940nm diode, for the disruption of subcutaneous adipose tissue and skin tightening.
Detailed description
The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1064nm laser Treatment Before Abdominoplasty | Experimental | Device: 1064nm LaserPatient will be treated with 1064nm Laser prior to abdominoplasty |
| 940nm Laser Treatment Before Abdominoplasty | Experimental | Device: 940nm LaserPatient will be treated with 940nm Laser prior to abdominoplasty |
Who may qualify
- Ages
- 20 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Non-smoking subjects between ages of 20-55 years of age presenting excess abdominal tissue (fat and skin), are candidates for an abdominoplasty procedure and are willing to allow the use of this device on their skin
- Subjects (Group 2 and 3) who will allow the excess skin removed as part of the abdominoplasty to be sent for laboratory analysis
- Understand and accept the obligation associated with the procedure
- Subjects with Fitzpatrick skin types I to VI.
- Subjects (Group 2 and 3) who are willing to consent to participate in the study will be asked to undergo treatment, elasticity and ultrasound measurements, as outlined for each group and defined in section 6.0.
Key exclusion criteria (12 listed)
- Any previous liposuction/lipo-sculpture or any type of procedure in the abdominal area in the past 6 months
- A history of allergic reactions to medications or anesthesia required for the procedure
- A history of thrombophlebitis
- A history of acute infections
- A history of heart failure
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 |
|---|---|---|
| 1064nm LaserPatient will be treated with 1064nm Laser prior to abdominoplasty | Device | 1064nm laser Treatment Before Abdominoplasty |
| 940nm LaserPatient will be treated with 940nm Laser prior to abdominoplasty | Device | 940nm Laser Treatment Before Abdominoplasty |
Primary outcome
Biopsy of Tissue Sample as a Measure of Effectiveness
Time frame: 6 months post treatment
Biopsy of treated area will be obtained up to 6 months post treatment and will be histologically assessed for changes in adipocytes, collagen and surrounding tissue to determine effectiveness of device
Ultrasound Measurement to Evaluate Reduction of Fat
Time frame: 6 months post treatment
Ultrasound of the treatment area will be performed and evaluated in comparison to the baseline results to determine reduction of fat
1 secondary outcome
High Frequency Ultrasound to Measure Skin Elasticity and Thickness
Time frame: 6 months post last treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
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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.
Patric Krantz 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 1064nm Laser and 940nm Laser in people with Subcutaneous Fat, 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 6 inclusion and 12 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: finished, as of the sponsor's last update on 27 Oct 2020. 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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Biopsy of Tissue Sample as a Measure of Effectiveness (time frame: 6 months post treatment). 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 27 Oct 2020.