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Safety and Effectiveness of Natrelle(TM) Cohesive Round Silicone-Filled Breast Implants

NCT00689871 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 715

Last updated 2014-10-13

Study results available
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Summary

Safety and effectiveness of Natrelle™ Cohesive Round Silicone-Filled Breast Implants in women undergoing primary augmentation, primary reconstruction, or revision of existing breast implants.

Conditions

  • Breast Augmentation
  • Breast Reconstruction
  • Revision of Augmentation or Reconstruction

Interventions

DEVICE

Natrelle(TM) Silicone-Filled Breast Implants

Breast implant surgery

Sponsors & Collaborators

  • Allergan Medical

    lead INDUSTRY

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
1999-01-31
Primary Completion
2010-12-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00689871 on ClinicalTrials.gov