In January 2005, the oversight responsibility of the Post-Approval Studies Program was transferred to the Division of Epidemiology (DEPI) of the Office of Surveillance and Biometrics (OSB)/Center for Devices and Radiological Health (CDRH).
The CDRH Post-Approval Studies Program encompasses design, tracking, oversight, and review responsibilities for studies mandated as a condition of approval of a premarket approval (PMA) application, protocol development product (PDP) application, or humanitarian device exemption (HDE) application. The program helps ensure that well-designed post-approval studies (PAS) are conducted effectively and efficiently and in the least burdensome manner.
CDRH has established an automated, internal tracking system that efficiently identifies the reporting status of active PAS studies ordered since January 1, 2005 based on study timelines incorporated in study protocols and agreed upon by the CDRH and applicants. This system represents CDRH's effort to ensure that all PAS commitments are fulfilled in a timely manner.
In addition, CDRH launched this publicly available webpage to keep all stakeholders informed of the progress of each PAS. The webpage displays general information regarding each PAS, as well as the overall study status (based on protocol-driven timelines and the adequacy of the data) and the applicant's reporting status for each submission due.
Site enrollment milestones not met,
Subject enrollment milestones not met
General Study Protocol Parameters
Randomized Clinical Trial
Study involve follow-up of premarket cohort (Y/N)
New Data Collection
Transit. Adolescent B (as adults) : 18-21 yrs,
Detailed Study Protocol Parameters
Study Design Description
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 System¿s 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.
Study Population Description
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.
A total of 440 subjects with 220 in each arm.
Co - Primary effectiveness endpoints are:
a. Sensitivity at the margin level b. Specificity at the
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
Followup Visits and Length of Followup
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).