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Reoperation Rate in Breast-Conserving Surgery Using Confocal Histolog® Scanner for Intraoperative Margin Assessment

NCT05946759 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 54

Last updated 2024-03-21

No results posted yet for this study

Summary

This PMPF study is proposed to evaluate in real life the reoperation rates (ROR) of breast cancer and/or DCIS surgery when including the use of the HLS in the context of breast lumpectomy margin assessment.

Conditions

  • Breast Cancer - Ductal Carcinoma in Situ (DCIS)
  • Breast-Conserving Surgery

Interventions

DEVICE

Histolog Scanner

The PMPF study is collecting data that includes the use of the CE Mark IVD Histolog Scanner for the breast lumpectomy margin assessment.

Sponsors & Collaborators

  • St. Vincenz Krankenhaus GmbH, Paderborn

    collaborator UNKNOWN

  • SamanTree Medical SA

    lead INDUSTRY

Principal Investigators

  • Michael P Lux, Prof. Dr MBA · St. Vincenz Krankenhaus GmbH, Paderborn

Study Design

Allocation
NON_RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-10
Primary Completion
2024-03-12
Completion
2024-03-12

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05946759 on ClinicalTrials.gov