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Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

NCT00905645 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 1788

Last updated 2024-01-11

Study results available
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Summary

Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.

Conditions

  • Breast Augmentation
  • Breast Reconstruction
  • Breast Revision

Interventions

DEVICE

Silimed Gel-Filled Mammary Implant

Sponsors & Collaborators

  • Tiger Biosciences, LLC.

    lead INDUSTRY

Principal Investigators

  • Denise Dajles, PhD · Tiger Biosciences, LLC.

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2002-11-30
Primary Completion
2018-12-31
Completion
2018-12-31

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 NCT00905645 on ClinicalTrials.gov