Assessment of Safety & Efficacy of Light Weight Breast Implant

November 2, 2015 updated by: Bnai Zion Medical Center
The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel
        • Bnai Zion

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
No reoperation
Time Frame: during 6 months follow up period
during 6 months follow up period

Secondary Outcome Measures

Outcome Measure
Time Frame
Duration for all adverse events (AEs) on per patient and per implant basis will be recorded and analyzed.
Time Frame: 6 month
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bnai Zion Medical Center

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

May 23, 2013

First Submitted That Met QC Criteria

June 7, 2013

First Posted (Estimate)

June 11, 2013

Study Record Updates

Last Update Posted (Estimate)

November 3, 2015

Last Update Submitted That Met QC Criteria

November 2, 2015

Last Verified

December 1, 2014

More Information

Terms related to this study

Other Study ID Numbers

  • 0007-13-BNZ

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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