A multi-centre clinical trial study evaluating the safety and functionality of the ORM-P2 System for differentiating tissue types in the resection bed during breast-conserving surgery.

OncoRes Medical Pty Ltd0 sites30 target enrollmentFebruary 27, 2023

Overview

No summary available.

Registry

who.int

Start Date

February 27, 2023

End Date

July 23, 2024

Last Updated

last year

Study Type

Interventional

Sex

Female

Sponsor

OncoRes Medical Pty Ltd

•Histologically confirmed invasive or in situ carcinoma
•Candidate for breast conserving surgery based on clinical and radiological evaluation by
•the Investigator
•Participant is capable of understanding, and willing to provide, written informed consent

•Pregnant, lactating or planning to become pregnant during the study
•Systemic infection or infection at the surgical site of the time of surgery.
•Nicotine user not having quit at least four weeks prior to surgery
•Any medical condition such as insulin dependent diabetes, chronic lung or severe
•cardiovascular disease that might, in the opinion of the Investigator, result in unduly high
•surgical risk and/or significant postoperative complications.
•Has any condition that, in the Investigator’s opinion, would preclude the use of the investigational medical device, may interfere with the evaluation of the investigational medical device or breast related outcomes or preclude the participant from completing the follow up visits.
•Have an active implanted stimulation device (i.e., implanted, defibrillator or pacemaker,
•deep brain stimulator, spinal cord stimulator).
•Be unwilling to comply with all investigational requirements.