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

NCT07080463 | Enrolling By Invitation Phase 1

• 1 other identifier: H24-02372
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Operative times

  surgery time

Secondary Outcomes (1)

• Chart review of surgical complications

  at 6 months

Study Arms (2)

not using vasculens

NO INTERVENTION

using vasculens

EXPERIMENTAL

Procedure: vasculens and cta

Interventions

vasculens and cta PROCEDURE

using vasculens and cta for one group and cta for the second group (control)

using vasculens

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC Breast Reconstruction Research Lab

Vancouver, British Columbia, V6T 2B5, Canada

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor and Surgeon

Study Record Dates

• First Submitted: July 14, 2025
• First Posted: July 23, 2025
• Study Start: May 1, 2025
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: March 10, 2026

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)