Following the Use of Gel Prosethetics in Breast Reconstruction

Following placement of silicone breast prosthetics for reconstruction

Completed

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–80 year

Sex eligibility

Female

Study type

Observational

Primary location

The University of California Irvine

Orange, California, 92868, United States

About this study

Patients undergoing breast reconstruction will be followed for outcomes after placement of silicone prostheses

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Women undergoing breast surgery

Exclusion criteria

Collagen vascular disease, Scleroderma

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

Mentor Worldwide, LLC

Registry information

Official study title

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

Important dates

Study start: 2001
Primary completion: 2013
Study completion: 2013
First posted: Jan 3, 2008
Registry last updated: Aug 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed