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

Completed

• Conditions: Breast Cancer
• Interventions: Device: ClearSight™ System

• Registration Number: NCT02679378
• Lead Sponsor: Clear Cut Medical Ltd.

Brief 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.

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 Timeline

• Study Start: 2015-10
• Study First Submitted: 2016-01-25
• Study First Submitted QC: 2016-02-09
• Study First Posted: 2016-02-10
• Primary Completion: 2017-12
• Study Completion: 2018-11
• Status Verified: 2023-02
• Last Update Submitted: 2023-02-07
• Last Update Posted: 2023-02-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 220

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ClearSight™ System	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.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

The George Washington University Hospital (GWU); 🇺🇸 Washington, District of Columbia, United States

University of Arkansas for Medical Sciences; 🇺🇸 Little Rock, Arkansas, United States

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Assaf Harofeh Medical Center; 🇮🇱 Zerifin 70300, Israel

Assuta Medical Center; 🇮🇱 Tel Aviv, Israel