Evaluation of Safety and Efficacy of Using Imagine™ Compu... | NCT00945685

Studies
Evaluation of Safety and Efficacy of Using Imagine™ Computerized Radiofrequency System for Skin Tightening

NCT00945685

Sponsor

Endymion Medical Ltd

Status

Completed

Last Update Posted

Jul 24, 2009Estimated

Enrollment

30Actual

Phase

Not Applicable

Conditions

Skin Aging
Skin Wrinkling

Interventions

Endymion Imagine™ System for Skin Tightening

Countries

Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2008

Primary Completion Date

Jun 2009Actual

Completion Date

Jul 2009Actual

First Submitted Date

Jul 23, 2009

First Submission Date that Met QC Criteria

Jul 23, 2009

First Posted Date

Jul 24, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2009

Last Update Posted Date

Jul 24, 2009Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Skin aging is a multifactorial process involving the 3 layers of the skin: Epidermis, dermis and hypodermis. Skin aging process involves among others: skin roughness (epidermis), skin dyschromia (epidermis, dermis), wrinkles and elastosis - skin texture changes due to collagen modification, skin laxity and cellulite (dermis and hypodermis).

EndyMion has developed the Imagine™ system - Computerized Radiofrequency System for Skin Tightening. By using a multielectrodes treatment tip an exact computerized thermal pattern can be produced allowing to selectively heating one or more of the target tissues (epidermis, dermis and hypodermis). In the skin tightening module the dermis and hypodermis would be targeted, creating enough thermal effect to induce collagen remodeling with no ablative thermal damage in the epidermis or dermis. This post marketing study is intended for evaluation of safety and efficacy of the Imagine™ system.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Endymion study group	Experimental		Device: Endymion Imagine™ System for Skin Tightening

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Endymion Imagine™ System for Skin Tightening	Device	Based on patient skin type and area of treatment the physician will choose the following parameters (some parameters are fixed): Pulse energy (J); RF frequency (1MHz); Pulse duration (30 sec); Treatment hand piece (skin tightening);

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
The safety of using the Imagine™ System for skin tightening will be established by physician's assessment/observation of adverse events (signs of pain, skin texture alterations or burn).		3 months

Secondary Outcomes

Measure	Description	Time Frame
Efficacy endpoint of using the Imagine™ System for skin tightening will be established by level of skin tightness improvement.		3 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy males and females age 30 and up
Subjects with Fitzpatrick 4 to 9 degrees of elastosis
Subject able to comprehend and give informed consent for participation in this study
Subject must commit to all treatments and follow-up visits
Subject must sign the Informed Consent Form

Exclusion Criteria:

Subjects with implanted pacemakers, arrhythmias or any other severe known heart disorder
Subjects with any implantable metal device in the treatment area
Subjects on any medication that would affect the characteristic of the skin (medical or hormonal), such as "Accutane", within the past 6 months
Subjects that have had any other invasive or non invasive method of skin therapy or hair removal performed in the past 6 months (in the treated area)
Subjects who are scheduled or planned for any other invasive or non invasive method of skin therapy or hair removal in the treatment area at the period of the study
Subjects who have any form of suspicious lesion on the treatment area
Subjects with history of keloid formations or hypertrophic scarring
Pregnant or lactating Subjects
Subjects with Epilepsy or severe migraines
Subjects with permanent makeup/ tattoo/ body piercing (in the treated area)
Subjects with any Infection / abscess / pains in treatment target area
Eczema or dermatitis
Subjects who suffer from autoimmune disorders or diabetes
Subjects using blood thinning medications
Subjects with clotting disorders
Subjects on drugs or psychologically determined unsuitable for the study
Subject is suffering extreme general weakness
Subject objects to the study protocol
Concurrent participation in any other clinical study
Physician objection

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

30 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided