Breast CancerNCT00594490
Evaluating the Effectiveness and Outcomes of Silicone Breast Prosthetics
An observational study of Breast Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
This trial will evaluate the outcome of placement of silicone breast prosthetics. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 132 participants
- Where
- 1 siteUnited States
- Study dates
- 24 May 2002to 19 Dec 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: women undergoing breast reconstruction
Who may be able to join
- over 18 undergoing breast reconstruction
Who cannot join
- patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.
- Study Closed
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of California, Irvine
Orange, California, 92868
About this study
Official title: Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
This trial will evaluate the outcome of placement of silicone breast prosthetics.
Read the detailed description
Patients will be evaluated for complications following placement of silicone breast prostheses.
- Conditions
- Breast Cancer
- Keywords
- Breast, reconstruction, silicone
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Silicone | patients undergoing placement of silicone breast prosthetics |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2008 (estimated)
- Study start24 May 2002
- Primary completion19 Dec 2013
- Study completion19 Dec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of California, IrvineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 132 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Irvine
- Sponsor type
- University, hospital or other
- Collaborators
- Mentor Worldwide, LLC
- Responsible party
- Principal investigator, Gregory R. Evans, University of California, Irvine
- Investigators
- Gregory Evans, Principal investigator, The University of California, Irvine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00594490
- Sponsor's protocol ID
- 2001-2192
- Status last verified
- Apr 2023
- First submitted
- 3 Jan 2008
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
- ClinicalTrials.gov ID
- NCT00594490
- Acronym / sponsor ID
- 2001-2192
- Conditions
- Breast Cancer
- Keywords
- Breast, reconstruction, silicone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 132 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Mentor Worldwide, LLC
- Study start
- 24 May 2002 (actual)
- Primary completion
- 19 Dec 2013 (actual)
- Study completion
- 19 Dec 2013 (actual)
- First posted
- 15 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This trial will evaluate the outcome of placement of silicone breast prosthetics.
Detailed description
Patients will be evaluated for complications following placement of silicone breast prostheses.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Silicone | – | –patients undergoing placement of silicone breast prosthetics |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women undergoing breast reconstruction
Key inclusion criteria (1 listed)
- over 18 undergoing breast reconstruction
Key exclusion criteria (2 listed)
- patients with collagen vascular diseases, rheumatoid arthritis, scleroderma, etc.
- Study Closed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Evans principal investigator
The University of California, Irvine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by University of California, Irvine at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2023.