Following the Use of Gel Prosethetics in Breast Reconstruction
This study is ongoing, but not recruiting participants.
Sponsor:
University of California, Irvine
Collaborator:
Mentor Worldwide, LLC
Information provided by (Responsible Party):
University of California, Irvine
ClinicalTrials.gov Identifier:
NCT00585884
First received: December 26, 2007
Last updated: February 6, 2013
Last verified: February 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 26, 2007 | ||||
| Last Updated Date | February 6, 2013 | ||||
| Start Date ICMJE | January 2000 | ||||
| Estimated Primary Completion Date | January 2025 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE | Not Provided | ||||
| Original Primary Outcome Measures ICMJE | Not Provided | ||||
| Change History | Complete list of historical versions of study NCT00585884 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Following the Use of Gel Prosethetics in Breast Reconstruction | ||||
| Official Title ICMJE | 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 | ||||
| Brief Summary | Following placement of silicone breast prosthetics for reconstruction |
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| Detailed Description | Patients undergoing breast reconstruction will be followed for outcomes after placement of silicone prostheses |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Time Perspective: Prospective | ||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | women over 18 undergoing breast reconstruction |
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| Condition ICMJE | Breast Cancer | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Not Provided | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Active, not recruiting | ||||
| Enrollment ICMJE | 20 | ||||
| Estimated Completion Date | January 2025 | ||||
| Estimated Primary Completion Date | January 2025 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Female | ||||
| Ages | Not Provided | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00585884 | ||||
| Other Study ID Numbers ICMJE | 2000-1383 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | University of California, Irvine | ||||
| Study Sponsor ICMJE | University of California, Irvine | ||||
| Collaborators ICMJE | Mentor Worldwide, LLC | ||||
| Investigators ICMJE |
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| Information Provided By | University of California, Irvine | ||||
| Verification Date | February 2013 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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