Virtual Reality 3D-Surgery Modeling to Enhance Head and Neck Cancer Surgery Quality
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorThomas Jefferson University
About this trial
This clinical trial studies the use of virtual reality technology and three dimensional surgery (3D-surgery) modeling to enhance current treatments in head and neck cancer surgery. Virtual reality 3D-surgery modeling may improve quality of surgical planning and interdisciplinary communication between surgeons and pathologists during the treatment of head and neck squamous cell cancer and ultimately increase the accuracy of planning, the quality of communication, and maximize the outcome patients with head and neck cancer experience throughout treatment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Diagnosed with cancer of the head and neck (oral cavity, oropharynx, larynx, hypopharynx, T1-T4)
Receiving treatment at Thomas Jefferson University - Center City by a fellowship-trained HNC surgeon
Eligible for definitive resection
Age > 18
Disqualifiers
Impaired judgement or those unable to provide informed consent
Any factor that would place the patient at increased risk or preclude the individual's full compliance with or completion of the study
Nasopharyngeal carcinoma
Contraindications for surgery
Trial design
Design model
Parallel
Treatments tested in this trial
Medical Device Usage and Evaluation
Other interventionUndergo virtual reality imaging via VR/3D-CEPs
Best Practice
Other interventionReceive standard of care
Resection
Procedure/SurgeryUndergo surgical resection
Treatment groups
160 Participants
are divided into 2 treatment groupsGroup A: Arm I (VR/3D-CEPs, standard treatment)Experimental treatment 3 interventions
Group B: Arm II (standard treatment)Active comparator 2 interventions
Trial outcomes
Primary outcomes
1
Margin events
Will be defined as the number of positive margins along with the number of unexpected defect driven margins. Will be collected for patients in the control group and patients treated with the use of preoperative planning with virtual reality (VR). Margin events will be defined as binary (yes/no) on post-operative survey to be completed by surgeons. Logistic regression will be used to evaluate of a difference in any margin event between study groups (3 dimensional \[3D\] VR vs. control) adjusted for surgeon.
Time frame
Up to Completion of surgical resectionSecondary outcomes
1
Event free survival
Logistic regression will be used to estimate an odds ratio and 95% confidence interval (CI).
Time frame
The time from completion of treatment to marginal recurrence of tumor at the primary site, assessed up to 3 yearsSponsors and contacts
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Source ClinicalTrials.gov