Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Status Recruiting

Clinical Trial Summary

Multi center, pivotal prospective, randomized clinical trial The proposed randomized controlled study will evaluate the benefits of adding the ClearEdge imaging device to the Standard of Care (SoC) of margins assessment in breast conserving surgeries. The study will assess whether there is an improvement in the detection of DCIS or invasive cancer involved margins by measuring whether removal at the time of primary surgical treatment can reduce the need for repeat surgeries as compared to the SoC, which does not use the device.

Clinical Trial Description

ClearEdge is a CE marked device already been used in several hospitals in the UK. It was used in a prospective single arm and 2 phases clinical study. It was demonstrated that surgeons successfully used the device to identify DCIS or invasive cancer involved margins and that it can reduce the need for repeat surgeries by meeting the margins depth criteria to require repeat operations. European Journal of Oncology Surgery. 2016; 42 (12): 1834-1840. In addition, the device was clinically evaluated by several hospitals. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT05456373
Study type	Interventional
Source	LS BioPath
Contact	Moshe Sarfaty, PhD
Phone	408-464-4051
Email	moshe@lsbiopath.com
Status	Recruiting
Phase	N/A
Start date	October 10, 2022
Completion date	December 31, 2024

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