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Evaluation of the Safety and Precursors of Efficacy

NCT ID: NCT02098811

Last Updated: 2020-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2014-05-31

Brief Summary

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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

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The purpose of the biopsies is to assess if the device causes an inflammatory response in the abdominoplasty tissue that will be excised.

Conditions

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Subcutaneous Fat

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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1064nm laser Treatment Before Abdominoplasty

Patient will be treated with 1064nm Laser prior to abdominoplasty

Group Type EXPERIMENTAL

1064nm Laser

Intervention Type DEVICE

Patient will be treated with 1064nm Laser prior to abdominoplasty

940nm Laser Treatment Before Abdominoplasty

Patient will be treated with 940nm Laser prior to abdominoplasty

Group Type EXPERIMENTAL

940nm Laser

Intervention Type DEVICE

Patient will be treated with 940nm Laser prior to abdominoplasty

Interventions

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1064nm Laser

Patient will be treated with 1064nm Laser prior to abdominoplasty

Intervention Type DEVICE

940nm Laser

Patient will be treated with 940nm Laser prior to abdominoplasty

Intervention Type DEVICE

Eligibility Criteria

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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

* 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
Minimum Eligible Age

20 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cynosure, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Patric Krantz

Role: STUDY_DIRECTOR

Cynosure, Inc.

Locations

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Aesthetic Pavilion

Staten Island, New York, United States

Site Status

Countries

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United States

Other Identifiers

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CYN13-NIF-JD-04

Identifier Type: -

Identifier Source: org_study_id