Assessment of Safety & Efficacy of Light Weight Breast Implant

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bnai Zion Medical Center
ClinicalTrials.gov Identifier:
NCT01874652
First received: May 23, 2013
Last updated: July 24, 2014
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Capsular Contracture of Breast Implant, Sequela
Device: Light Weight Breast Implants
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: Yes ]

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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 50
Study Start Date: December 2013
Estimated Study Completion Date: December 2014
Estimated 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

Ages Eligible for Study:   18 Years to 65 Years
Genders 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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01874652

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

No publications provided

Responsible Party: Bnai Zion Medical Center
ClinicalTrials.gov Identifier: NCT01874652     History of Changes
Other Study ID Numbers: 0007-13-BNZ
Study First Received: May 23, 2013
Last Updated: July 24, 2014
Health Authority: Israel: Ministry of Health

Additional relevant MeSH terms:
Contracture
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases

ClinicalTrials.gov processed this record on September 14, 2014