Application of VascuLens 2.0, A Mixed Reality System for Surgical Guidance During DIEP Flap Harvest (NCT07080463) | Clinical Trial Compass
By InvitationPhase 1
Application of VascuLens 2.0, A Mixed Reality System for Surgical Guidance During DIEP Flap Harvest
Canada60 participantsStarted 2025-05-01
Plain-language summary
This study incorporates the use of the VascuLens system, which relies on a mixed reality headset and software system, during the pre-operative stage of DIEP flap surgery. VascuLens utilizes augmented reality (AR) technology to project vasculature images obtained from computed tomography angiography (CTA) onto the patient's body. These projections are then traced onto the patient, and the accuracy of the key vascular anatomical landmarks in the projected images is compared to the accuracy of the conventional surgical markings of the same anatomical landmarks against the actual location of the dissected blood vessels. Higher accuracy may lead to improved patient care, reduced operative time and reduced risk of complications.
Who can participate
Age range
19 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients must be ≥ 19 years old
* Patients must be undergoing a DIEP flap surgery after mastectomy for breast cancer or risk reduction
* Patient is already scheduled for a pre-operative CTA as part of routine standard of care.
Note: Non-English speaking participants will be given the option to have a translator.
Exclusion Criteria:
* Patients who have had a prior DIEP flap, as they may not have standard vascular anatomy and the previous surgery may have resulted in scarring and fibrosis that would potentially interfere with the accuracy of the projected anatomical information.
* Patients who have not had a pre-operative CTA because no imaging-based surgical guidance can be provided
* Patients who are pregnant at the time of surgery
* Patients who had a pre-operative CTA done before they were considered for this trial
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.