Exploratory Study Comparing ClearSight System 2D Map to Post Surgery Histopathological Analysis in Lumpectomy

February 7, 2023 updated by: Clear Cut Medical Ltd.

Clinical Study of the ClearSight™ System to Evaluate the Ability to Distinguish Malignant From Non-malignant Breast Tissue by Comparing MR Measurements of Freshly Excised Breast Tissue to Histopathology

Prospective, single-arm, multicenter, open label, non-randomized exploratory clinical study comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study is a multicenter, non-randomized, cross-sectional comparative exploratory study comparing the ClearSight System 2D map results to post surgery histopathological analysis of excised mass in lumpectomy surgery. The Efficacy Objective is to assess the ability of the ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery using histopathological assessment as reference. The Safety Objective is that all adverse events, serious adverse events (SAE) will be reported according to local regulations. The actual reporting is discussed in section 0. No device-related adverse events are expected. For more information please refer to the Investigator Brochure.

Study Type

Observational

Enrollment (Actual)

220

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Rehovot, Israel
        • Kaplan Medical Center
      • Tel Aviv, Israel
        • Assuta Medical Center
      • Zerifin 70300, Israel
        • Assaf Harofeh Medical Center
  • United States
    • Arkansas
      • Little Rock, Arkansas, United States, 72205
        • University of Arkansas for Medical Sciences
    • District of Columbia
      • Washington, District of Columbia, United States, 20037
        • The George Washington University Hospital (GWU)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 99 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with primary breast cancer

Description

Inclusion Criteria:

  1. Women histologically diagnosed with carcinoma of the breast, scheduled for primary lumpectomy (partial mastectomy) procedure.
  2. Age ≥18.
  3. Signed ICF

Exclusion Criteria:

  1. Prior surgical procedure in the same breast within 12 months prior to the surgery date.
  2. Recurrent breast cancer surgery.
  3. Neoadjuvant chemotherapy.
  4. Previous radiation therapy to the operated breast.
  5. Pregnant / breast feeding.
  6. Participating in any other study that might affect results.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
ClearSight™ System
To assess the ability of the ClearSight™ System to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery when compared to histopathological assessment.
Device: ClearSight™ System
comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Malignant and non-malignant breast tissues will be assessed by ClearSight™ to detect malignant tissue less than or equal to 1 mm of margins of excised breast specimen in breast conserving surgery using histopathological assessment as reference
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clear Cut Medical Ltd.

Investigators

  • Principal Investigator: Dr. Christine B. Teal, Dr., The George Washington University (GWU)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

October 1, 2015

Primary Completion (ACTUAL)

December 1, 2017

Study Completion (ACTUAL)

November 1, 2018

Study Registration Dates

First Submitted

January 25, 2016

First Submitted That Met QC Criteria

February 9, 2016

First Posted (ESTIMATE)

February 10, 2016

Study Record Updates

Last Update Posted (ACTUAL)

February 8, 2023

Last Update Submitted That Met QC Criteria

February 7, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • 710CLD Rev. 02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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