NCT00585884

Brief Summary

Following placement of silicone breast prosthetics for reconstruction

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Feb 2001

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2001

Completed
6.9 years until next milestone

First Submitted

Initial submission to the registry

December 26, 2007

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 3, 2008

Completed
5.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 23, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 23, 2013

Completed
Last Updated

August 14, 2023

Status Verified

August 1, 2023

Enrollment Period

12.6 years

First QC Date

December 26, 2007

Last Update Submit

August 9, 2023

Conditions

Breast Cancer

Keywords

Reconstruction, Silicone prostheses

Eligibility Criteria

Age18 Years - 80 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

women over 18 undergoing breast reconstruction

You may qualify if:

  • Women undergoing breast surgery

You may not qualify if:

  • Collagen vascular disease, Scleroderma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of California Irvine

Orange, California, 92868, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Jeff Lewis

    Mentor Worldwide, LLC

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 26, 2007

First Posted

January 3, 2008

Study Start

February 1, 2001

Primary Completion

September 23, 2013

Study Completion

September 23, 2013

Last Updated

August 14, 2023

Record last verified: 2023-08

Locations

US(1)