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

> **NCT00753922** · PHASE3 · COMPLETED · sponsor: **Mentor Worldwide, LLC** · enrollment: 1008 (actual)

## Conditions studied

- Breast Reconstruction
- Breast Augmentation
- Breast Revision

## Interventions

- **DEVICE:** Mentor Round Low Bleed Gel-filled Mammary Protheses, both Siltex and Smooth Surface

## Key facts

- **NCT ID:** NCT00753922
- **Lead sponsor:** Mentor Worldwide, LLC
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2000-09
- **Primary completion:** 2012-06
- **Final completion:** 2012-06
- **Target enrollment:** 1008 (ACTUAL)
- **Last updated:** 2014-04-16


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT00753922

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT00753922, "Core Gel Study of the Safety and Effectiveness of Mentor Round Low Bleed Silicone Gel-filled Mammary Prostheses". Retrieved via AI Analytics 2026-06-23 from https://api.ai-analytics.org/clinical/NCT00753922. Licensed CC0.

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