Assessment of Safety & Efficacy of Light Weight Breast Implant
NCT ID: NCT01874652
Last Updated: 2015-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
50 participants
INTERVENTIONAL
2013-12-31
2014-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
NONE
Study Groups
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Light Weight Breast Implants
Assessment of Safety and Efficacy of Light Weight Breast Implant
Light Weight Breast Implants
Light Weight Breast Implants
Interventions
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Light Weight Breast Implants
Light Weight Breast Implants
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
FEMALE
Yes
Sponsors
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Bnai Zion Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Noam Calderon, md
Role: PRINCIPAL_INVESTIGATOR
Bnai-Zion
Locations
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Bnai Zion
Haifa, , Israel
Countries
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Other Identifiers
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0007-13-BNZ
Identifier Type: -
Identifier Source: org_study_id
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