Completed PHASE3 INTERVENTIONAL 4-arm NCT00753922

Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses

Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses in Patients Who Are Undergoing Primary Breast Augmentation, Primary Breast Reconstruction or Revision

Sponsor: Mentor Worldwide, LLC

Conditions Breast Augmentation Breast Reconstruction Breast Revision

Interventions Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface

Updated 8 times since 2017 Last updated: Mar 21, 2014 Started: Sep 30, 2000 Primary completion: Jun 30, 2012 Completion: Jun 30, 2012

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE3 clinical study on Breast Augmentation and Breast Reconstruction, this trial is completed. The trial is conducted by Mentor Worldwide, LLC and has accumulated 8 data snapshots since 2000. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

8 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Dec 2021 — Jul 2024 [monthly]

Completed PHASE3
Jan 2021 — Dec 2021 [monthly]

Completed PHASE3
Sep 2020 — Jan 2021 [monthly]

Completed PHASE3

▶ Show 3 earlier versions

Jun 2018 — Sep 2020 [monthly]

Completed PHASE3
Feb 2017 — Jun 2018 [monthly]

Completed PHASE3
Jan 2017 — Feb 2017 [monthly]

Completed PHASE3

First recorded

Sep 2000

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Mentor Worldwide, LLC

Data source: Mentor Worldwide, LLC

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Santa Barbara, United States