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| General |
| Study Status |
Ongoing |
Application Number /
Requirement Number |
P030053 S069/ PAS001 |
| Date Original Protocol Accepted |
01/17/2025
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| Date Current Protocol Accepted |
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| Study Name |
Athena PAS
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| Device Name |
MemoryGel® Ultra High Profile - Extended Range (UH-R) Breast Implants
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| Clinical Trial Number(s) |
NCT02724371
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| General Study Protocol Parameters |
| Study Design |
Prospective Cohort Study
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| Data Source |
Other Data Source
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| Comparison Group |
No Control
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| Analysis Type |
Analytical
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| Study Population |
Transit. Adolescent B (as adults) : 18-21 yrs,
Adult: >21
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| Detailed Study Protocol Parameters |
| Study Objectives |
Demonstrate safety and effectiveness of Mentor’s larger size Ultra High Profile (UHP-L) smooth and textured breast implants in women who are undergoing post-mastectomy primary reconstruction or revision reconstruction.
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| Study Population |
The study planned to enroll a minimum of 280 (maximum 400) patients. The actual enrollment was completed in January 2019 with 400 patients.
Enrollment numbers by indication:
• Primary Reconstruction in women at least 18 years old with surgically absent breast tissue (post-mastectomy, requiring a two-stage breast reconstruction): the study planned to enroll a minimum of 180 patients; the actual enrollment was 225 patients.
• Revision Reconstruction in women at least 18 years old with surgically absent breast tissue: the study planned to enroll a minimum 100 patients; the actual enrollment was 175 patients.
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| Sample Size |
The study enrolled 225 primary reconstruction subjects and 175 revision reconstruction subjects.
The calculation of the minimum number of subjects required in the primary reconstruction cohort is based on the precision of estimates for the complication rates at 2 years. Consideration is also given to the precision of estimated complication rates at 3 and 5 years for the cohort as well as to the precision of estimates within the ADM subsets at the subject level, using 2-sided 95% confidence intervals. The calculation of the minimum number of subjects required in the revision reconstruction cohort is based upon the minimally detectable complication rate of 3.3% within the Revision Reconstruction cohort without ADM use.
Enrollment of at least 20 subjects per implant size will be targeted and achieved. Implant sizes 750-800cc may be pooled together to reach a reasonable number of subjects for the smallest pooled implant size. Implant sizes of 1340-1445cc may be pooled together to reach a reasonable number of subjects per the largest pooled implant sizes. Enrollment of subjects in each size will be monitored and no plans to cap enrollment in any specific size are being made at this time so as to reflect real world demand and usage.
Total number of sites: the study planned to enroll patients in up to 35 (Each PI/site may have multiple facilities and/or multiple surgeons for performing surgery, located in the United States.); the actual enrollment occurred in 31 sites.
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| Key Study Endpoints |
The following safety endpoints are being evaluated to assess the safety of the device:
• The incidence, timing and resolution of all complications.
• The incidence, timing and nature of difficulties with pregnancy.
• The incidence, timing, and cause of subject deaths.
• The incidence, timing, and type of any new breast cancer diagnosis for the subject post-implantation.
Effectiveness is being assessed during the study based on subject-reported outcomes for self-esteem, body image, and general health. Subject satisfaction and investigator satisfaction will also be assessed.
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| Follow-up Visits and Length of Follow-up |
Subject visits have been planned at baseline, operative visit, 10 weeks post implant, and annually up to 10 years. MRIs or ultrasound were scheduled at year 3, 5, 7, 9 and 10.
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