Breast CancerNCT00585884
Following the Use of Gel Prosethetics in Breast Reconstruction
An observational study of Breast Cancer, run by University of California, Irvine at 1 site in United States.
Trial summary
Following placement of silicone breast prosthetics for reconstruction 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
- 3 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Feb 2001to 23 Sep 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 over 18 undergoing breast reconstruction
Who may be able to join
- Women undergoing breast surgery
Who cannot join
- Collagen vascular disease, Scleroderma
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: 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
Following placement of silicone breast prosthetics for reconstruction
Read the detailed description
Patients undergoing breast reconstruction will be followed for outcomes after placement of silicone prostheses
- Conditions
- Breast Cancer
- Keywords
- Reconstruction, Silicone prostheses
- Medical subject headings
- Breast Neoplasms
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2008 (estimated)
- Study start1 Feb 2001
- Primary completion23 Sep 2013
- Study completion23 Sep 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
- 3 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
- Jeff Lewis, Study chair, Mentor Worldwide, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00585884
- Sponsor's protocol ID
- 20001383
- Status last verified
- Aug 2023
- First submitted
- 26 Dec 2007
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT00585884
- Acronym / sponsor ID
- 20001383
- Conditions
- Breast Cancer
- Keywords
- Reconstruction, Silicone prostheses
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University of California, IrvineUniversity, hospital or other
- Collaborators
- Mentor Worldwide, LLC
- Study start
- 1 Feb 2001 (actual)
- Primary completion
- 23 Sep 2013 (actual)
- Study completion
- 23 Sep 2013 (actual)
- First posted
- 3 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.
Following placement of silicone breast prosthetics for reconstruction
Detailed description
Patients undergoing breast reconstruction will be followed for outcomes after placement of silicone prostheses
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- women over 18 undergoing breast reconstruction
Key inclusion criteria (1 listed)
- Women undergoing breast surgery
Key exclusion criteria (1 listed)
- Collagen vascular disease, Scleroderma
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 14 Aug 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.
Jeff Lewis study chair
Mentor Worldwide, LLC
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 1 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 14 Aug 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 14 Aug 2023.