NCT01874652

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Dec 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 23, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

June 11, 2013

Completed
6 months until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

November 3, 2015

Status Verified

December 1, 2014

Enrollment Period

1 year

First QC Date

May 23, 2013

Last Update Submit

November 2, 2015

Conditions

Breast Implants

Outcome Measures

Primary Outcomes (1)

  • No reoperation

    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.

    6 month

Study Arms (1)

Light Weight Breast Implants

EXPERIMENTAL

Assessment of Safety and Efficacy of Light Weight Breast Implant

Device: Light Weight Breast Implants

Interventions

Light Weight Breast ImplantsDEVICE

Light Weight Breast Implants

Light Weight Breast Implants

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bnai Zion

Haifa, Israel

Location

Study Officials

  • Noam Calderon, md

    Bnai-Zion

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 23, 2013

First Posted

June 11, 2013

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

November 3, 2015

Record last verified: 2014-12

Locations

IL(1)