Status:
COMPLETED
MarginProbe 2.0 Data Collection Protocol
Lead Sponsor:
Dilon Medical Technologies Ltd.
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Brief Summary
Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpecto...
Eligibility Criteria
Inclusion
- Women over 18 years of age
- Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure
- Signed Informed Consent Form
Exclusion
- Undergoing re-excision procedure
- Concurrent infectious disease
- Pregnancy
- Lactation
- Previous surgery in the same site including open biopsy procedure, previous breast reduction or mastopexy in the operated breast
- Prior radiation treatment in the operated breast
- Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Key Trial Info
Start Date :
December 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
January 12 2025
Estimated Enrollment :
398 Patients enrolled
Trial Details
Trial ID
NCT05377229
Start Date
December 15 2021
End Date
January 12 2025
Last Update
August 28 2025
Active Locations (9)
Enter a location and click search to find clinical trials sorted by distance.
1
Glendale Adventist Medical Center
Glendale, California, United States, 91206
2
Mercy Medical Center
Cedar Rapids, Iowa, United States, 52403
3
Logan Health Breast Center
Kalispell, Montana, United States, 59901
4
Englewood Health
Englewood, New Jersey, United States, 07631