Breast Reconstruction With Silicone ImplantsNCT00581984
McGhan Medical Silicone-Filled Breast Implant Adjunct Study
An observational study of Breast Reconstruction With Silicone Implants, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial summary
This study will collect 5 year data about any possible health problems associated with breast implants. This data will be used to help see if the implants are both safe and effective. If they are proven safe and effective, they will continue to be available. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Breast Reconstruction With Silicone Implants
- How many people
- 1,016 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 1998to Oct 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Study population: Females who are candidates for breast reconstructio
Who may be able to join
- Females of any age for which breast reconstruction is considered appropriate. (Patients under 18 years old require parental/legal guardian consent to participate).
- Have any of the following conditions or situations present:
- Post mastectomy surgical removal of the breast for cancer or other diseases;
- Post trauma or post surgery where there was total or partial removal of the breast resulting in significant deformity.(for any reason);
- Severe ptosis requiring reconstruction (i.e. mastopexy);.
- Any congenital or acquired discrepancy in breast size such as to represent a significant physical deformity. This does not include normal variants of asymmetry. Examples include, but are not limited to:Pectus excavatum, Pectus carinatum; Thoracic hypoplasia (Poland's syndrome, Scoliosis; Isolated rib deformities; Tuberous breasts; Congenital absence
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- Revision of implant procedure due to any of the following circumstances;
- Previous augmentation or reconstruction with silicone- or saline-filled implants where problems exist, such as implant. rapture or significant capsular contracture (Baker Grade III or IV) requiring revision;
- Contralateral mammaplasty in unaffected breast as a result of the affected breast requiring surgery (for one of the aforementioned circumstances), when medically indicated to provide symmetry.
- Adequate tissue available to cover implants.
- Saline-filled implants are not an appropriate choice.
- Willingness to follow all study requirements, such as agreeing to all required follow-up visits, and acceptance of the risks involved as indicated by signing of the Patient Informed Consent document.
Who cannot join
- Advanced fibrocystic disease considered to be premalignant-without accompanying subcutaneous mastectomy.
- Existing carcinoma of the breast, without mastectomy.
- Abscess or infection in the body at the time of enrollment.
- Pregnant or nursing.
- Have any disease, including uncontrolled diabetes; which is clinically known to impact wound healing ability.
- Show tissue characteristics which are clinically incompatible with mammaplasty, such as tissue damage resulting from radiation, inadequate tissue, compromised vascularity or ulceration.
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- Have, or under treatment for, any condition which, in the opinion of the surgeon, may constitute an unwarranted surgical risk.
- Show psychological characteristics which, in the opinion of the surgeon, may be incompatible with the surgical procedure and the prosthesis, such as inappropriate attitude or motivation.
- Wish to have augmentation mammaplasty, but do not have at least one of the diagnoses identified in Patient Inclusion Criteria item G #2, pages 7 \& 8.
- Are not willing to undergo further surgery for revision, if medically required.
- Diagnosis of lupus or scleroderma.
- Replacement of saline-filled implants solely for a less than desirable cosmetic outcome, such as wrinkling.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan-Kettering Cancer Center
New York, New York, 10065
About this study
This study will collect 5 year data about any possible health problems associated with breast implants. This data will be used to help see if the implants are both safe and effective. If they are proven safe and effective, they will continue to be available. If they are not proven safe and effective to the satisfaction of the FDA, they may not be available in the future.
Read the detailed description
This prospective clinical study is being undertaken to document the safety of McGhan Medical Silicone-Filled Breast Implants. Patients will be evaluated pre-operatively, intraoperatively, and at one, three and five years following implant surgery. Safety of McGhan Medical Silicone-Filled Breast Implants will be assessed based on the incidence of medical complications, implant failure and serious adverse effects.
This prospective clinical study of McGhan Medical Silicone-Filled Breast Implants is part of an ongoing research effort to document the safety and effectiveness of silicone-filled breast implants.
- Keywords
- breast cancer, breast reconstruction, silicone implants
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of breast implant complications
Measured: 10 years 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2007 (estimated)
- Study startSep 1998
- Primary completionOct 2013
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Reconstruction With Silicone ImplantsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,016 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Cordeiro, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00581984
- Sponsor's protocol ID
- 98-089
- Status last verified
- Oct 2013
- First submitted
- 21 Dec 2007
- Last updated
- 16 Oct 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- McGhan Medical Silicone-Filled Breast Implant Adjunct Study
- ClinicalTrials.gov ID
- NCT00581984
- Acronym / sponsor ID
- 98-089
- Keywords
- breast cancer, breast reconstruction, silicone implants
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,016 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Sep 1998
- Primary completion
- Oct 2013 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 28 Dec 2007 (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 study will collect 5 year data about any possible health problems associated with breast implants. This data will be used to help see if the implants are both safe and effective. If they are proven safe and effective, they will continue to be available. If they are not proven safe and effective to the satisfaction of the FDA, they may not be available in the future.
Detailed description
This prospective clinical study is being undertaken to document the safety of McGhan Medical Silicone-Filled Breast Implants. Patients will be evaluated pre-operatively, intraoperatively, and at one, three and five years following implant surgery. Safety of McGhan Medical Silicone-Filled Breast Implants will be assessed based on the incidence of medical complications, implant failure and serious adverse effects.
This prospective clinical study of McGhan Medical Silicone-Filled Breast Implants is part of an ongoing research effort to document the safety and effectiveness of silicone-filled breast implants.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Females who are candidates for breast reconstructio
Key inclusion criteria (12 listed)
- Females of any age for which breast reconstruction is considered appropriate. (Patients under 18 years old require parental/legal guardian consent to participate).
- Have any of the following conditions or situations present:
- Previous augmentation or reconstruction with silicone- or saline-filled implants where problems exist, such as implant. rapture or significant capsular contracture (Baker Grade III or IV) requiring revision;
- Adequate tissue available to cover implants.
- Saline-filled implants are not an appropriate choice.
Key exclusion criteria (12 listed)
- Advanced fibrocystic disease considered to be premalignant-without accompanying subcutaneous mastectomy.
- Existing carcinoma of the breast, without mastectomy.
- Abscess or infection in the body at the time of enrollment.
- Pregnant or nursing.
- Have any disease, including uncontrolled diabetes; which is clinically known to impact wound healing ability.
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
Evidence of breast implant complications
Time frame: 10 years 3 months
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 16 Oct 2013.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
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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.
Peter Cordeiro, MD principal investigator
Memorial Sloan Kettering Cancer Center
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 Reconstruction With Silicone Implants, run by Memorial Sloan Kettering Cancer Center 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 12 inclusion and 12 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 16 Oct 2013. 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.
What does the primary outcome measure?
Evidence of breast implant complications (time frame: 10 years 3 months). It is what the study was designed to measure, not a finding.
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 16 Oct 2013.