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General |
Study Status |
Completed |
Application Number / Requirement Number |
P110014 / PAS001 |
Date Original Protocol Accepted |
12/27/2012
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Date Current Protocol Accepted |
09/02/2019
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Study Name |
MarginProbe System US PAS
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Device Name |
DUNE MEDICAL DEVICES MARGINPROBE SYSTEM
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General Study Protocol Parameters |
Study Design |
Randomized Clinical Trial
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Data Source |
New Data Collection
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Comparison Group |
Concurrent 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 |
This is a prospective, newly enrolled, multicenter, randomized, double arm, controlled study of adjunctive use of the MarginProbe System (Standard of Care (SOC)+Device) versus standard of care, including additional inspection (SOC+Additional Inspection). The study objective is to determine the MarginProbe Systems diagnostic accuracy at the margin level and impact on Positive Margin Presence originating from the main ex-vivo lumpectomy specimen after the initial lumpectomy surgery.
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Study Population |
Women histologically diagnosed with carcinoma of the breast and women with non-palpable malignant lesions, requiring image guided localization who undergo lumpectomy (partial mastectomy) procedure.
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Sample Size |
A total of 440 subjects with 220 in each arm.
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Key Study Endpoints |
Co - Primary effectiveness endpoints are: a. Sensitivity at the margin level b. Specificity at the margin level c. Incomplete Surgical Resection (ISR) - Positive Margin on the Main ex-vivo lumpectomy specimen after the initial lumpectomy surgery that was not addressed by taking a shaving(s) corresponding to the positive margin(s). Secondary effectiveness endpoints are: a. Proportion of patients with Positive Margin presence on the Outermost Shaving after the initial lumpectomy surgery (PMO) b. Cosmesis evaluation: - Objective evaluation by an evaluator blinded to arm assignment - Subject's self-reported evaluation. c. Repeat lumpectomy rate - Proportion of patients who underwent a repeat lumpectomy procedure d. Repeat lumpectomy and mastectomy rate - Proportion of patients who underwent a repeat lumpectomy procedure or a mastectomy e. Diagnostic Accuracy at the Patient Level (ignoring location) - Proportion of patients from whom shavings were taken
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Follow-up Visits and Length of Follow-up |
Patients will be followed until evaluation of cosmetic status, performed at 6 +/- 1 month following the end of surgical treatment (either conversion to mastectomy, or the latest ipsilateral repeat lumpectomy procedure).
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Interim or Final Data Summary |
Actual Number of Patients Enrolled |
438 subjects
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Actual Number of Sites Enrolled |
12 Enrolled Study Sites
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Patient Follow-up Rate |
276/438 completed follow up visit in window = 63.01% 13/438 completed follow up visit < 30 out of window = 2.97% 52/438 completed follow up 1-3 months out of window = 11.87% 70/438 completed follow up > 3 months out of window = 15.98% 411/438 completed study follow up = 93.83%
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Final Safety Findings |
A total of 190 AEs (not including SAEs) were reported in the study, 98 (51%) within Device+SOP group and 92 (48.4%) within SOC+Additional Inspection Group. For 90 subjects AEs were reported, 48 (53%) subjects within Device+SOC group and 42 (46.7%) within SOC+Additional Inspection Group. From the 98 AEs within the Device+SOC group, 1 was classified as possible related to the device. 2 deaths occurred during this study; both unrelated to the device. Use of the MarginProbe proven safe and not associated with increased risk over Control Group.
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Final Effect Findings |
All components of the primary endpoint met predetermined study success criteria. The Sensitivity and Specificity at Margin Level co-primary endpoints were met at 70.2% and between 47.6% (worst case) and 48.7% (best case) respectively. These results are comparable to the 73.8% sensitivity and 45.1% specificity reported in the MarginProbe Pivotal trial. Device demonstrated decreased rates of incomplete surgical resection (ISR) compared to control arm. Secondary endpoints: Rate of positive margin presence on the outermost shaving after initial lumpectomy surgery (PMO), Cosmesis Blinded Evaluation, repeat lumpectomy/mastectomy rate, sensitivity, sensitivity, and Cosmesis Self Assessment. PMO endpoint met established success criteria. All other secondary endpoints demonstrated that the Device group may have qualitative non-inferiority compared to the Control group; however, these observations were not statistically significant.
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Study Strengths & Weaknesses |
Strength: Randomized Controlled Study with comprehensive endpoints. Inclusion of evaluator and self-reported evaluation of cosmesis. Weaknesses: Missing Data for Secondary Effectiveness Endpoints due to incomplete evaluations due to COVID19
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Recommendations for Labeling Changes |
We recommend labelling changes to reflect the results from the primary effectiveness endpoints (i.e. sensitivity, specificity, ISR) and PMO/Cosmesis secondary endpoints.
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