Mentor Adjunct Study for Silicone Gel-Filled Mammary Prosthesis
Public ClinicalTrials.gov record NCT00948948. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Mentor is undertaking a five-year prospective clinical study designed to collect safety data associated with the implantation of its gel-filled mammary prostheses. This study is an "adjunct" study, which will encompass clinical reviews of reconstructive cases in all patients who meet clinical and regulatory criteria for breast reconstruction with gel-filled mammary prostheses. This "adjunct" study will be accomplished under a limited clinical protocol in which specific parameters will be required but with controls somewhat less stringent than those normally required in Investigational Device Exemption (IDE) Trials.
Study identification
- NCT ID
- NCT00948948
- Recruitment status
- Approved For Marketing
- Study type
- Expanded access
- Phase
- Not listed
- Enrollment
- Not listed
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- Female
- Healthy volunteers
- Not listed
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Not listed
- Primary completion
- Not listed
- Completion
- Not listed
- Last update posted
- Apr 4, 2013
United States locations
- U.S. sites
- 1
- U.S. states
- 1
- U.S. cities
- 1
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Mentor Worldwide LLC | Santa Barbara | California | 93111 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT00948948, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 4, 2013 · Synced Sep 11, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT00948948 live on ClinicalTrials.gov.