CompletedNCT02098811Updated Oct 27, 2020

Evaluation of the Safety and Precursors of Efficacy

An interventional study of 1064nm Laser and 940nm Laser in Subcutaneous Fat, sponsored by Cynosure, Inc.. Completed at 1 site in United States. Open to participants aged 20 Years to 55 Years. Per ClinicalTrials.gov, last updated 2020-10-27.

Sponsored by Cynosure, Inc. · Not applicable, Interventional, and Device feasibility

Phase: Not applicable
Study type: Interventional
Enrollment: 10
Allocation: Randomized
Ages: 20 Years to 55 Years
Sex: All

Study 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 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 studied

Subcutaneous Fat

In context

Lead sponsor

Cynosure, Inc. is the lead sponsor of 52 studies on the registry; 2 are open to participants now.

Of its 21 completed or terminated interventional studies of FDA-regulated products, 16 (76%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 20 Years to 55 Years
Sexes eligible: All
Accepts healthy volunteers: No

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

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
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

Study design

Phase: Not applicable
Primary purpose: Device feasibility
Allocation: Randomized
Intervention model: Parallel assignment
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Experimental
1064nm laser Treatment Before Abdominoplasty
Patient will be treated with 1064nm Laser prior to abdominoplasty
Device: 1064nm Laser
Experimental
940nm Laser Treatment Before Abdominoplasty
Patient will be treated with 940nm Laser prior to abdominoplasty
Device: 940nm Laser

Interventions

Device1064nm Laser
Patient will be treated with 1064nm Laser prior to abdominoplasty
Device940nm Laser
Patient will be treated with 940nm Laser prior to abdominoplasty

What researchers measure

Primary outcomes

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
Time frame: 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
Time frame: 6 months post treatment

Secondary outcomes

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.
Time frame: 6 months post last treatment

Study locations

1 site

Aesthetic Pavilion
Staten Island, New York 103206, United States

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Oct 27, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02098811
Lead sponsor: Cynosure, Inc.
Responsible party: Sponsor
First posted: Mar 28, 2014
Start date: Jun 2013
Primary completion: May 2014
Completion: May 2014
Last update: Oct 27, 2020

Study contacts

Patric Krantz

study director · Cynosure, Inc.

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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