CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 1,788 enrolled
Drug / intervention
Silimed Gel-Filled Mammary Implantdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00905645
NCT00905645N/ACompleted
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Sientra Sponsored Silimed Gel-Filled Mammary Implant Clinical Study Protocol: Core Clinical Investigation

Tiger Biosciences, LLC.·interventional·Posted May 20, 2009·Updated Jan 11, 2024

In Brief

A clinical study evaluating Silimed Gel-Filled Mammary Implant for Breast Augmentation and 2 related conditions. Completed, enrolled 1,788 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Augmentation, Breast Reconstruction, Breast Revision
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
2003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 20, 2009
Enrollment StartNov 1, 2002
Primary CompletionDec 1, 2018
TodayJul 2, 2026
Enrollment to primary: 16.1 yearsPosted 17.1 years ago

Interventions

Silimed Gel-Filled Mammary Implantdevice