Application of VascuLens 2.0, A Mixed Reality System for Surgical Guidance During DIEP Flap Harvest
Enrolling by invitation · Phase 1
Conditions studied: Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07080463
- Run by
- University of British Columbia
- People needed
- 60
- Starts
- 2025-05-01
- Expected to finish
- 2027-05-01
- Last updated by the study team
- 2026-03-10
Who can join
Age: 19 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- UBC Breast Reconstruction Research Lab — Vancouver, British Columbia, Canada
Full record on ClinicalTrials.gov
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