Status:
COMPLETED
Assessment of Safety & Efficacy of Light Weight Breast Implant
Lead Sponsor:
Bnai Zion Medical Center
Conditions:
Breast Implants
Eligibility:
FEMALE
18-65 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT01874652
Start Date
December 1 2013
End Date
December 1 2014
Last Update
November 3 2015
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Bnai Zion
Haifa, Israel