NCT02098811

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2013

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

March 25, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 28, 2014

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

October 27, 2020

Status Verified

October 1, 2020

Enrollment Period

11 months

First QC Date

March 25, 2014

Last Update Submit

October 23, 2020

Conditions

Subcutaneous Fat

Outcome Measures

Primary Outcomes (2)

  • 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

    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

    6 months post treatment

Secondary Outcomes (1)

  • High Frequency Ultrasound to Measure Skin Elasticity and Thickness

    6 months post last treatment

Study Arms (2)

1064nm laser Treatment Before Abdominoplasty

EXPERIMENTAL

Patient will be treated with 1064nm Laser prior to abdominoplasty

Device: 1064nm Laser

940nm Laser Treatment Before Abdominoplasty

EXPERIMENTAL

Patient will be treated with 940nm Laser prior to abdominoplasty

Device: 940nm Laser

Interventions

1064nm LaserDEVICE

Patient will be treated with 1064nm Laser prior to abdominoplasty

1064nm laser Treatment Before Abdominoplasty
940nm LaserDEVICE

Patient will be treated with 940nm Laser prior to abdominoplasty

940nm Laser Treatment Before Abdominoplasty

Eligibility Criteria

Age20 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aesthetic Pavilion

Staten Island, New York, 103206, United States

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical DevicesEquipment and SuppliesRadiation Equipment and Supplies

Study Officials

  • Patric Krantz

    Cynosure, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
DEVICE FEASIBILITY
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 25, 2014

First Posted

March 28, 2014

Study Start

June 1, 2013

Primary Completion

May 1, 2014

Study Completion

May 1, 2014

Last Updated

October 27, 2020

Record last verified: 2020-10

Locations

US(1)