Assessment of Safety & Efficacy of Light Weight Breast Implant

• Sponsor: Bnai Zion Medical Center (Other)
• Overall Status: Completed
• CT.gov ID: NCT01874652
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arm: 1
• Duration (Months): 12
• Patients Per Site Per Month: 4.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Implants	Device: Light Weight Breast Implants	Phase 2

Detailed Description

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

Study Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Official Title: Assessment of Safety & Efficacy of Light Weight Breast Implant
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Dec 1, 2014
• Actual Study Completion Date: Dec 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Light Weight Breast Implants Assessment of Safety and Efficacy of Light Weight Breast Implant	Device: Light Weight Breast Implants; Light Weight Breast Implants

Outcome Measures

Primary Outcome Measures

1. No reoperation [during 6 months follow up period]

Secondary Outcome Measures

1. Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed. [6 month]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Bnai Zion	Haifa		Israel

Sponsors and Collaborators

• Bnai Zion Medical Center

Investigators

• Principal Investigator: Noam Calderon, md, Bnai-Zion

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Bnai Zion Medical Center
• ClinicalTrials.gov Identifier: NCT01874652
• Other Study ID Numbers: 0007-13-BNZ
• First Posted: Jun 11, 2013
• Last Update Posted: Nov 3, 2015
• Last Verified: Dec 1, 2014

Study Results

No Results Posted as of Nov 3, 2015