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NCT00905645 · ClinicalTrials.gov registry record · NA

Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study

A NA study, sponsored by Tiger Biosciences.

Completed
Registry status
NA
Development phase
1,788
Enrollment target

NCT00905645: Completed NA study, sponsored by Tiger Biosciences.

NCT00905645 is a NA study that has completed, run by Tiger Biosciences. The registered enrollment target is 1,788 participants, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT00905645, a NA study, has completed, sponsored by Tiger Biosciences.

COMPLETED
Registry status
NA
Development phase
1,788 participants
Enrollment target

Study 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.

Primary Outcome

Assessment of the safety of the Study Implants is based on the incidence of adverse events through 10 years.

Interventions

  • DEVICE Silimed Gel-Filled Mammary Implant

Trial Details

FieldValue
Enrollment Target 1,788 participants
Start Date 2002-11
Est. Completion 2018-12
Phase NA
Tiger Biosciences

4 total trials

What the finished NCT00905645 record still lists

NCT00905645 is an interventional study that assigns participants to a tested intervention. Its 1,788 participants enrollment target places it among the larger protocols in the corpus, above the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (27% higher).

The record links to 0 conditions, and to 1 intervention - of which Silimed Gel-Filled Mammary Implant is the first listed.

NCT00905645 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT00905645 about?

NCT00905645 is a clinical study titled "Sientra Sponsored Silimed Gel-Filled Breast Implant Core Clinical Study". Safety and effectiveness of the Silimed Gel-Filled Mammary Implant as indicated for primary augmentation, primary reconstruction, and/or revision of the female breast.

What is the current status of trial NCT00905645?

This trial is currently completed. It is a NA study. The enrollment target is 1,788 participants. The study started on 2002-11. Estimated completion is 2018-12.

What interventions are being tested in trial NCT00905645?

The interventions under investigation include: Silimed Gel-Filled Mammary Implant (DEVICE).

Who is sponsoring clinical trial NCT00905645?

This trial is sponsored by Tiger Biosciences, which has 4 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT00905645's enrollment target sits among peer trials

1,788 59th of 2000 higher than 1,942 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT00905645, the US trial registry maintained by the National Library of Medicine. NCT00905645 (large enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.