Intraoperative Use of ClearEdge Device in Breast Conserving Surgery

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.

Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT05456373.

Trial PhaseNo phase specified

Trial Typetreatment

Lead OrganizationLS BioPath

• Primary IDLSB-12345
• Secondary IDsNCI-2023-04136
• ClinicalTrials.gov IDNCT05456373