Assessment of Safety & Efficacy of Light Weight Breast Im... | NCT01874652

Studies
Assessment of Safety & Efficacy of Light Weight Breast Implant

NCT01874652

Sponsor

Bnai Zion Medical Center

Status

Completed

Last Update Posted

Nov 3, 2015Estimated

Enrollment

50Actual

Phase

Phase 2

Conditions

Breast Implants

Interventions

Light Weight Breast Implants

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

Dec 2014

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

Dec 2013

Primary Completion Date

Dec 2014Actual

Completion Date

Dec 2014Actual

First Submitted Date

May 23, 2013

First Submission Date that Met QC Criteria

Jun 7, 2013

First Posted Date

Jun 11, 2013Estimated

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

Nov 2, 2015

Last Update Posted Date

Nov 3, 2015Estimated

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

The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.

Detailed Description

This is a Single-center. The purpose of the study is to evaluate safety and effectiveness of LWBI in breast augmentation.

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

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Light Weight Breast Implants	Experimental	Assessment of Safety and Efficacy of Light Weight Breast Implant	Device: Light Weight Breast Implants

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Light Weight Breast Implants	Device	Light Weight Breast Implants	Light Weight Breast Implants

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
No reoperation		during 6 months follow up period

Secondary Outcomes

Measure	Description	Time Frame
Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed.		6 month

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Genetic women at ages 18 to 65 seeking breast enlargement
Signed informed consent
Agreement to complete all required follow up visits
A medically acceptable candidate
Sufficient breast tissue for proper implant coverage (≥20 mm by pinch test)

Exclusion Criteria:

Patients with active infection anywhere in their body
Women who are currently pregnant or nursing
Insufficient tissue covering in the prospective area of implantation (e.g. after preceding breast reduction), radiation damage or reduced vascularization
Abscesses, malignant tumors(cancer or recurrent metastases), advanced fibrocystic diseases
Patients with a history of psychiatric treatment
Patients that been implanted with any silicone implant (e.g. silicone artificial joints, facial implants)
Expected allergies or extraordinary immune response to implants
Wound healing impairments or heavy burn scars
Existing costal injuries
The Patient Participated in an investigational trial within 30 days of enrollment

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

65 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided