A multi-centre clinical trial evaluating the safety and functionality of a medical imaging device for tissue review during breast-conserving surgery.
- Conditions
- Breast CancerCancer - Breast
- Registration Number
- ACTRN12623000205639
- Lead Sponsor
- OncoRes Medical Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Female
- Target Recruitment
- 30
Female
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the safety of the use of the ORM-P2 System for the duration of the device use.<br>Adverse events will be assessed during and after the surgical procedure, as well as at the follow up visit (end of study visit) on day 7 post op by clinical examination by the Investigator. [ Device related serious adverse events which result in death or permanent disability during the follow up period from surgery/index procedure, immediately post operatively to discharge and at the surgical post operative review (end of study visit). ]
- Secondary Outcome Measures
Name Time Method To evaluate the differentiated tissue assessment for the detection of tissue with elevated stiffness in the resection bed during breast conserving surgery (Sensitivity and specificity of the differentiated tissue)<br>[ At end of study, during data analysis.];Histological assessment of excised tissue will be conducted post operatively as per standard of care. [ 4 weeks post operatively]