Assessment of Safety & Efficacy of Light Weight Breast Implant

Phase 2

Completed

• Conditions: Breast Implants
• Interventions: Device: Light Weight Breast Implants

• Registration Number: NCT01874652
• Lead Sponsor: Bnai Zion Medical Center

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.

Study Timeline

• Study First Submitted: 2013-05-23
• Study First Submitted QC: 2013-06-07
• Study First Posted: 2013-06-11
• Study Start: 2013-12
• Status Verified: 2014-12
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Last Update Submitted: 2015-11-02
• Last Update Posted: 2015-11-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Light Weight Breast Implants	Light Weight Breast Implants	Assessment of Safety and Efficacy of Light Weight Breast Implant

Primary Outcome Measures

Name	Time	Method
No reoperation	during 6 months follow up period

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Bnai Zion; 🇮🇱 Haifa, Israel