Application of VascuLens 2.0, A Mixed Reality System for Surgical Guidance During DIEP Flap Harvest: A Randomized Controlled Trial

Launched by UNIVERSITY OF BRITISH COLUMBIA · Jul 14, 2025

Keywords

ClinConnect Summary

This early-stage trial is testing whether the VascuLens mixed-reality system can help surgeons plan and perform a specific breast reconstruction surgery (DIEP flap) more quickly and with fewer problems. The DIEP flap uses tissue from the belly to reconstruct the breast. In the study, about 60 adult women who are already scheduled for this surgery will be randomly assigned to two groups: one group uses the VascuLens AR guidance plus the usual CT angiography (CTA) images, and the other uses CTA images alone. Participants won’t know which group they’re in. The study is led by the University of British Columbia in Vancouver and results aren’t available yet.

If you join, you’ll have the standard care visits you’d normally have for this surgery. The VascuLens part adds about 10-15 minutes before the operation and another 10-15 minutes during planning, but it doesn’t require extra clinic visits. The researchers will measure how long the surgery takes and check for complications after surgery (about 1 month and 6 months later), such as hernias, need for another operation, flap problems, or wound healing issues. Eligibility requires being 19 or older, undergoing a DIEP flap after mastectomy or risk-reduction, and having a pre-operative CTA; people who have had a prior DIEP flap, are pregnant, or don’t have a CTA are not eligible. The study is enrolling by invitation and aims to complete around May 2027.

Gender

FEMALE

Eligibility criteria

• 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