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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02679378
• Other study ID #: 710CLD Rev. 02
• Status: Completed
• Start date: October 2015
• Est. completion date: November 2018

Study information

• Verified date: February 2023
• Source: Clear Cut Medical Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: November 2018
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• ClearSight™ System
comparing ClearSight system to histopathological to determine negative-margins in breast conserving surgery.

Locations

Country	Name	City	State
Israel	Kaplan Medical Center	Rehovot
Israel	Assuta Medical Center	Tel Aviv
Israel	Assaf Harofeh Medical Center	Zerifin 70300
United States	University of Arkansas for Medical Sciences	Little Rock	Arkansas
United States	The George Washington University Hospital (GWU)	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Clear Cut Medical Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		12 months