VascuLens 2.0 for Varicose Veins

(VascuLens RCT Trial)

Age: 18+

Sex: Female

Trial Phase: Phase 1

Sponsor: University of British Columbia

Disqualifiers: Prior DIEP flap, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new technology called VascuLens 2.0, which uses augmented reality (AR) to help doctors see blood vessels more clearly before surgery. The goal is to improve accuracy during DIEP flap surgeries, commonly performed after mastectomy for breast cancer. By comparing VascuLens with traditional methods, researchers aim to make surgeries safer and faster. Suitable participants for this trial are those scheduled for a DIEP flap surgery who have already undergone a special scan called CTA. As a Phase 1 trial, this research focuses on understanding how VascuLens 2.0 works in people, offering participants the opportunity to be among the first to experience this innovative technology.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that the VascuLens system is safe for use in pre-operative DIEP flap surgery?

Research has shown that VascuLens 2.0 is in the early stages of testing to assess its safety for people. As it is just beginning, complete safety information is not yet available. This phase primarily focuses on evaluating the treatment's safety and tolerability. The technology uses augmented reality (AR) to project images onto the body, which is generally safer than drug or surgical treatments. No specific side effects have been reported so far, but this phase helps identify any potential issues. Participants should be aware that, as with any new technology, some unknowns exist, though the risk is typically lower. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Most treatments for varicose veins, like compression stockings or sclerotherapy, focus on managing symptoms or closing the affected veins. VascuLens 2.0 is unique because it uses advanced imaging technology to precisely target the veins, potentially improving accuracy and effectiveness in treatment. Researchers are excited about VascuLens 2.0 because it offers a non-invasive approach that could reduce recovery times and improve patient outcomes compared to traditional methods.

What evidence suggests that the VascuLens system is effective for improving surgical accuracy in DIEP flap surgery?

Research has shown that the VascuLens 2.0 system, which participants in this trial may receive, might improve surgery results for varicose veins. It uses augmented reality to make precise markings on the body, displaying clear images of blood vessels to help surgeons make more accurate cuts. The goal is to reduce surgery time and lower the risk of complications by identifying blood vessels more accurately. Although this system is new, the technology appears promising. Related studies have demonstrated that precise surgical techniques can lead to better recovery and overall quality of life. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

This trial is for individuals undergoing DIEP flap surgery, which is often used in breast reconstruction. Participants must have varicose veins and be eligible for the surgery. Specific inclusion and exclusion criteria are not listed but would typically involve factors like overall health status and any contraindications to surgery or imaging.

Inclusion Criteria

I am 19 years old or older.

I am having DIEP flap surgery after a mastectomy for breast cancer or as a preventive measure.

Patient is already scheduled for a pre-operative CTA as part of routine standard of care. Non-English speaking participants will be given the option to have a translator.

Exclusion Criteria

Patients who had a pre-operative CTA done before they were considered for this trial

I have had a DIEP flap surgery, which may affect my vascular anatomy.

Patients who have not had a pre-operative CTA because no imaging-based surgical guidance can be provided

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Pre-operative

Pre-operative stage where CTA images are reviewed and anatomical information is marked onto the patient

10-15 minutes

1 visit (in-person)

Operative

Operative procedure where DIEP flap harvest is performed with or without VascuLens system

8 hours

1 visit (in-person)

Follow-up

Participants are monitored for surgical complications and outcomes post-operation

6 months

Multiple visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• VascuLens 2.0

Trial Overview The study tests VascuLens 2.0, a mixed reality system that projects vascular images from CTA scans onto the patient's body during pre-op planning for DIEP flap harvest. The goal is to see if this AR tech improves accuracy compared to traditional surgical markings.

How Is the Trial Designed?

Group I: using vasculens Experimental Treatment 1 Intervention

Group II: not using vasculens Active Control 1 Intervention

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10864052/

A Follow-Up Study of up to 12 Years The efficacy of EVLT in managing varicose veins is demonstrated by its relatively low recurrence rate over a 10-year follow-up period.

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1805186

Five-Year Outcomes of a Randomized Trial of Treatments ... In a randomized trial of treatments for varicose veins, disease-specific quality of life 5 years after treatment was better after laser ablation or surgery ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S2213333X24004232

Comparative study on the effectiveness and safety of ... This study evaluates the clinical outcomes, quality-of-life effects, and postoperative complications of simultaneous and staged bilateral radiofrequency ...

4. jvsvenous.org jvsvenous.org/article/S2213-333X(21)00414-5/fulltext

Cost-effectiveness analysis of current varicose veins ... To analyze the effectiveness and cost effectiveness of technologies for treatment of varicose veins over 5 years—conservative care, surgery ( ...

5. ahdbonline.com ahdbonline.com/issues/2016/november-2016-vol-9-no-8/treatment-patterns-and-outcomes-in-patients-with-varicose-veins

Treatment Patterns and Outcomes in Patients with Varicose ... To assess varicose vein treatment patterns and their corresponding outcomes, including additional treatment rates, disease progression to new ulcers, and ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT07080463

Application of VascuLens 2.0, A Mixed Reality System for ... This study incorporates the use of the VascuLens system, which relies on a mixed reality headset and software system, ...

7. withpower.com withpower.com/clinical-trials/for-varicose-veins

Top Varicose Veins Clinical Trials | Power Phase 1 trials are the trials to collect safety data in humans. ... Most recently, we added Vein Embolization for Chronic Pelvic Pain, VascuLens 2.0 for Varicose ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S0890509624008197/pdf

Real-World Safety and Efficiency of Treating Symptomatic ... The aim of this study was to investigate the 16 month closure rates and safety of the VenaSeal system for the treatment of lower limb varicose vein surgery.

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5405826/

A multicenter, randomized, placebo-controlled study to ... A randomized, placebo-controlled, multicenter study was conducted to evaluate the safety and efficacy of polidocanol endovenous microfoam (1%, Varithena® [ ...

10. jvsvenous.org jvsvenous.org/article/S2213-333X(24)00580-8/fulltext

Safety assessment of cyanoacrylate closure for treatment ... A nationwide survey of CAC for varicose veins in Japan demonstrated that it was a safe procedure with a low rate of serious AEs, such as venous thromboembolism.