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Safety and Effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-filled X-Style and L-Style Breast Implants

NCT01785069 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 355

Last updated 2020-06-25

Study results available
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Summary

This is a prospective, multicenter study of the safety and effectiveness of NATRELLE® 410 Highly Cohesive, Anatomically Shaped, Silicone-Filled X-Style and L-Style Breast Implants.

Conditions

  • Breast Augmentation
  • Breast Reconstruction
  • Breast Implant Revision

Interventions

DEVICE

Anatomically shaped, silicone-filled breast implants with low projection or extra-full projection

Surgical implant

Sponsors & Collaborators

  • Allergan

    lead INDUSTRY

Principal Investigators

  • Andrew Schumacher · Allergan

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-12-10
Primary Completion
2015-11-30
Completion
2015-11-30
FDA Device
Yes

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 NCT01785069 on ClinicalTrials.gov