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NATRELLE® 410 Full and Moderate Height/Projection Breast Implant Continued Access Post-Approval Study

NCT01853605 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 3811

Last updated 2015-08-11

Study results available
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Summary

Post-approval study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive Anatomically Shaped Silicone-Filled Breast Implants (Styles 410 FM, FF, MM, or MF) for breast augmentation, reconstruction, or revision

Conditions

  • Breast Augmentation
  • Breast Reconstruction
  • Breast Implant Revision

Interventions

DEVICE

Anatomically shaped silicone gel-filled breast implants

Surgical implant

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Medical Director · Allergan Medical

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2003-04-30
Primary Completion
2014-08-31
Completion
2014-08-31

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 NCT01853605 on ClinicalTrials.gov