None listed
Conditions
Brief summary
The research project is testing a new imaging/treatment device for use during breast conserving surgery, involving the use of a medical device called ORM-P2 System. The purpose of this study is to find out if it is safe to use the ORM-P2 System during breast conserving surgery for patients with breast cancer. Who is it for? You may be eligible for this study if you are a woman aged 18 years or older, you have been diagnosed with invasive or in situ breast cancer and you are eligible to undergo breast conserving surgery as part of your cancer treatment. Study details All participants who choose to enrol in this study will be asked to attend three study visits scheduled over a 4 month period. The first visit will be a screening visit to determine whether you are eligible to enrol in the study. Those participants who are eligible to enrol will continue with their standard cancer care and will be scheduled for a breast conserving surgery. The surgery will be undertaken per standard protocols, with the addition of the ORM-P2 medical device. During the surgery, a clinician will use the device to scan the breast tissue. The device will provide images on the tissue's optical and mechanical properties on a micro-scale. Use of the device is anticipated to add 5 to 10 minutes to the overall surgery time. At 4 weeks after the surgery, participants will be asked to attend a final study visit where a surgical review and adverse event assessment will be undertaken. It is hoped this research will determine whether use of the ORM-P2 System is effective at differentiating tissue types remaining in the surgical cavity.
Interventions
This study will assess the safety and functionality of the ORM-P2 System. The ORM-P2 System is a handheld optical imaging system for intra-operative use during Breast Conserving Surgery (BCS) used by the surgeon and viewed on a screen during surgery. Surgeons will be trained in the use of the device by OncoRes Medical Pty Ltd on the intended use, precautions, scanning protocol and contraindication in the use of the device.
Participants will undergo standard of care breast conserving surgery
This study will assess the safety and functionality of the ORM-P2 System. The ORM-P2 System is a handheld optical imaging system for intra-operative use during Breast Conserving Surgery (BCS) used by the surgeon and viewed on a screen during surgery. Surgeons will be trained in the use of the device by OncoRes Medical Pty Ltd on the intended use, precautions, scanning protocol and contraindication in the use of the device. Participants will undergo standard of care breast conserving surgery for breast cancer (approx. 30 to 45 min duration). During the surgery the investigational medical device will be used, adding 5-10 min to standard of care surgery, to guide the excision of tissue by measuring properties of the tissue. Participants will take part in 3 study visits (duration of 1-2 hrs per visit) over 4 months. At the end of the trial participants will continue to receive standard of care treatment for their condition at the Institution.
Sponsors
OncoRes Medical Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Exclusion criteria
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.
Outcome results
None listed