Spots Global Cancer Trial Database for Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

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Trial Identification

Brief Title: Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Official Title: Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

Study ID: NCT05456373

Conditions

Breast Cancer

Interventions

ClearEdge device

Study Description

Brief 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.

Detailed 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.