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 range19 Years

SexFEMALE

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

What they're measuring

Operative times

Timeframe: surgery time

Trial details

NCT IDNCT07080463

SponsorUniversity of British Columbia

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-05-01