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OpenTrials
Completed

NCT Number: NCT01874652

Assessment of Safety & Efficacy of Light Weight Breast Implant

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

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Key information

Conditions

Breast Implants

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 2

Primary location

Bnai Zion

Haifa, Israel

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Light Weight Breast Implants

Device

Light Weight Breast Implants

Primary outcomes

  1. No reoperation

    Time frame: during 6 months follow up period

Secondary outcomes

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

    Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Bnai Zion Medical Center

Other Gov

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jun 11, 2013
Registry last updated
Nov 3, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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