Assessment of Safety & Efficacy of Light Weight Breast Implant

Breast Implants Clinical Trial

Official title:

Assessment of Safety & Efficacy of Light Weight Breast Implant

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01874652
• Other study ID #: 0007-13-BNZ
• Status: Completed
• Phase: Phase 2
• First received: May 23, 2013
• Last updated: November 2, 2015
• Start date: December 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: Bnai Zion Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

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

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Breast Implants

Intervention

Device:
• Light Weight Breast Implants
Light Weight Breast Implants

Locations

Country	Name	City	State
Israel	Bnai Zion	Haifa

Sponsors (1)

Lead Sponsor	Collaborator
Bnai Zion Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	No reoperation		during 6 months follow up period	Yes
Secondary	Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed.		6 month	Yes