Assessment of Safety & Efficacy of Light Weight Breast Implant

Bnai Zion Medical Center

Status and phase: Completed; Phase 2

Conditions: Breast Implants

Treatments: Device: Light Weight Breast Implants

Study type: Interventional

Funder types: Other

Identifiers

NCT01874652

0007-13-BNZ

Details and patient eligibility

About

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

Full description

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

Enrollment: 50 patients

Sex: Female

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

50 participants in 1 patient group

Light Weight Breast Implants

Experimental group

Description:

Assessment of Safety and Efficacy of Light Weight Breast Implant

Treatment:

Device: Light Weight Breast Implants