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Assessment of Safety & Efficacy of Light Weight Breast Implant

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01874652
First Posted: June 11, 2013
Last Update Posted: November 3, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Bnai Zion Medical Center
  Purpose
The purpose of this study is to evaluate safety and effectiveness of Light Weight Breast Implant (LWBI) in breast augmentation.

Condition Intervention Phase
Breast Implants Device: Light Weight Breast Implants Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Official Title: Assessment of Safety & Efficacy of Light Weight Breast Implant

Resource links provided by NLM:


Further study details as provided by Bnai Zion Medical Center:

Primary Outcome Measures:
  • No reoperation [ Time Frame: during 6 months follow up period ]

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

Enrollment: 50
Study Start Date: December 2013
Study Completion Date: December 2014
Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Light Weight Breast Implants
Assessment of Safety and Efficacy of Light Weight Breast Implant
Device: Light Weight Breast Implants
Light Weight Breast Implants

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01874652


Locations
Israel
Bnai Zion
Haifa, Israel
Sponsors and Collaborators
Bnai Zion Medical Center
Investigators
Principal Investigator: Noam Calderon, md Bnai-Zion
  More Information

Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01874652     History of Changes
Other Study ID Numbers: 0007-13-BNZ
First Submitted: May 23, 2013
First Posted: June 11, 2013
Last Update Posted: November 3, 2015
Last Verified: December 2014