Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics

NCT ID: NCT00594490

Last Updated: 2023-04-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

132 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-05-24

Study Completion Date

2013-12-19

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Patients will be evaluated for complications following placement of silicone breast prostheses.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Breast Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Silicone

patients undergoing placement of silicone breast prosthetics

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* over 18 undergoing breast reconstruction

Exclusion Criteria

* patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.

Study Closed
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Mentor Worldwide, LLC

INDUSTRY

Sponsor Role collaborator

University of California, Irvine

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Gregory R. Evans

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Gregory Evans

Role: PRINCIPAL_INVESTIGATOR

The University of California, Irvine

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

The University of California, Irvine

Orange, California, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2001-2192

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Sientra Post-Approval Study
NCT01639053 UNKNOWN
Spectra Breast Implant Study
NCT00981266 WITHDRAWN PHASE3