NCT00594490

Brief Summary

This trial will evaluate the outcome of placement of silicone breast prosthetics.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2002

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

May 24, 2002

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

January 3, 2008

Completed
12 days until next milestone

First Posted

Study publicly available on registry

January 15, 2008

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 19, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 19, 2013

Completed
Last Updated

April 27, 2023

Status Verified

April 1, 2023

Enrollment Period

11.6 years

First QC Date

January 3, 2008

Last Update Submit

April 26, 2023

Conditions

Breast Cancer

Keywords

Breast, reconstruction, silicone

Study Arms (1)

Silicone

patients undergoing placement of silicone breast prosthetics

Eligibility Criteria

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

women undergoing breast reconstruction

You may qualify if:

  • over 18 undergoing breast reconstruction

You may not qualify if:

  • patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.
  • Study Closed

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

  • Gregory Evans

    The University of California, Irvine

    PRINCIPAL INVESTIGATOR

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

January 3, 2008

First Posted

January 15, 2008

Study Start

May 24, 2002

Primary Completion

December 19, 2013

Study Completion

December 19, 2013

Last Updated

April 27, 2023

Record last verified: 2023-04

Locations

US(1)