Renal Cell Carcinoma (Kidney Cancer)NCT06960174
Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery
A study testing Virtual reality in people with Renal Cell Carcinoma (Kidney Cancer), run by St. Antonius Hospital.
Trial summary
Rationale: Preoperative planning for both partial and radical nephrectomies using conventional CT imaging can be challenging due to complex renal anatomy and vascularization. 3D models in virtual reality (VR) may enhance anatomical understanding and improve preoperative planning. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Cell Carcinoma (Kidney Cancer)
- What is being tested?
- Virtual reality
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 2 Jun 2025to 31 Jan 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18+
- Suspected RCC and candidate for (partial) nephrectomy
- Signed informed consent
Who cannot join
- Patients who are not approved to undergo surgery (due to comorbidities or their overall health condition)
- Patients who are unable to give informed consent
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Rationale:
Preoperative planning for both partial and radical nephrectomies using conventional CT imaging can be challenging due to complex renal anatomy and vascularization. 3D models in virtual reality (VR) may enhance anatomical understanding and improve preoperative planning. This study aims to prospectively evaluate the clinical impact of the use of 3D models in VR in the preoperative planning of partial and radical nephrectomies.
Read more
Objective:
The primary objective is to assess the impact of VR on preoperative planning and thereby on the agreement between the preoperative plan and the performed surgery in renal surgery (both partial and radical nephrectomies). The secondary objectives focus on the urologist's understanding of the anatomy and how the intraoperative and postoperative outcomes are influenced by the use of VR in the preoperative planning.
Study design:
The Virtual Renality study is a single-center randomized clinical trial conducted at the St. Antonius Hospital in Nieuwegein.
Study population:
The study population will consist of adult patients (18+) with a suspected RCC who are indicated for (partial) nephrectomy at St. Antonius Hospital Nieuwegein.
Intervention:
For the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the original CT scan during preoperative planning. For the control group, only the CT scan will be used for preoperative planning, according to the current standard of care.
Main study parameters/endpoints:
The primary study endpoint is the surgical concordance score, which describes the concordance between the actual performed surgery and the preoperatively determined surgical plan.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:
Participation in this study will not require any additional physical examinations, blood samples, hospital visits, or questionnaires beyond standard clinical care. The only difference for participants in the intervention group is that a 3D model will be created from the existing CT scan and reviewed in VR during preoperative planning by the urologist.
Read the detailed description
The Virtual Renality study is a single-center randomized clinical trial conducted at the St. Antonius Hospital in Nieuwegein. For the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the original CT scan during preoperative planning, whereas for the control group, only the CT scan will be used for preoperative planning, according to the current standard of care. The flowchart in Figure 1 provides an overview of the study design. The steps covered in the flowchart and the collection of parameters will be further explained later in this protocol. The study is single-blinded, as the 3D virtual model during preoperative planning is the assessed intervention. Participants will be randomly assigned to either the control group or the intervention group to eliminate selection bias and achieve comparability between the two groups. The urologists who perform (partial) nephrectomies at the St. Antonius Hospital will participate in the study. A total of 72 patients suspected of having a renal tumor and indicated for (partial) nephrectomy will be included. The inclusion period for the study will take approximately 7 months.
- Conditions
- Renal Cell Carcinoma (Kidney Cancer)
- Being tested
- Virtual reality
- Keywords
- Renal Cell Carcinoma, Partial nephrectomy, Radical nephrectomy, Preoperative planning, 3D virtual model, Virtual Reality
- Medical subject headings
- Carcinoma, Renal Cell, Kidney Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Virtual realityDevice
If the participant is assigned to the intervention group a 3D virtual model will be constructed. For the intervention group the CT + VR will be reviewed during preoperative planning.
| Study group | Role | What they receive |
|---|---|---|
| Preoperative planning based on CT | No intervention | For the control group the preoperative planning will be according to the current standard of care using only the CT scan. |
| Preoperative planning based on CT + VR | Experimental | For the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the CT scan during preoperative planning Receives: Device: Virtual reality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Concordance score between actual performed surgery and surgical plan
To assess whether the surgery is performed according to the preoperative plan, a questionnaire regarding the expected surgical steps will be completed during the preoperative planning. Postoperatively, the data will be collected from the surgical notes. The postoperative data will be compared with the preoperatively filled questionnaire and this will result in a concordance score between the actual performed surgery and the preoperatively determined surgical plan. This score of concordance will be the primary study endpoint
Measured: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Secondary outcomes (16)
Intra-operative parameters: method of clamping
Method of clamping (main renal artery / multiple arteries / no clamping / selective clamping)
Measured: Perioperative
Intraoperative parameters: blood loss
blood loss (value in ml)
Measured: Perioperative
Intraoperative parameters: clamping time
clamping time (value in mm:ss)
Measured: Perioperative
Intraoperative parameters: opening of collecting system
opening of collecting system (yes/no)
Measured: Perioperative
Intraoperative parameters: duration of surgery
duration of surgery (value in minutes)
Measured: Perioperative
Post-operative parameters: renal function
Renal function (Creatinine level before surgery, 1 day post-surgery and 4 weeks post-surgery )
Measured: Up to 1 month post-surgery
Post-operative parameters: 30-day post-surgery complications
30-day post-surgery complications ( Clavien Dindo score (Grade I / Grade II / Grade IIIa / Grade IIIb / Grade IVa / Grade IVb / Grade V) )
Measured: 30 days post-surgery
Post-operative parameters: hospital stay
hospital stay (days)
Measured: 30-days post-surgery
Post-operative parameters: readmission (within 30 days)
readmission (within 30 days) (yes/no)
Measured: 30-days post-surgery
Post-operative parameters: clean resection margin
clean resection margin (yes/no)
Measured: 30-days post-surgery
Post-operative parameters:
pathological TNM (TxNxMx)
Measured: 30-days post-surgery
Understanding of anatomy - renal arteries
Understanding of renal arteries (Very poor / Poor / Moderate / Good / Excellent)
Measured: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of anatomy - renal veins
Understanding of renal veins (Very poor / Poor / Moderate / Good / Excellent)
Measured: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of anatomy - collecting system
Understanding of collecting system (Very poor / Poor / Moderate / Good / Excellent)
Measured: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of anatomy - tumor
Understanding of tumor anatomy (Very poor / Poor / Moderate / Good / Excellent)
Measured: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of anatomy - general anatomy
Confidence in understanding of general anatomy (Strongly disagree / Disagree / Neutral / Agree / Strongly agree)
Measured: during preoperative planning (approximately 3 days before surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2025
- Study start2 Jun 2025 (estimated)
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Jan 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell Carcinoma (Kidney Cancer)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hille Torenvlied, St. Antonius Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06960174
- Sponsor's protocol ID
- NL-009626
- Status last verified
- Apr 2025
- First submitted
- 18 Apr 2025
- Last updated
- 7 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual Renality: Assessing the Impact of Virtual Reality on Preoperative Planning in Renal Cancer Surgery
- ClinicalTrials.gov ID
- NCT06960174
- Acronym / sponsor ID
- NL-009626
- Conditions
- Renal Cell Carcinoma (Kidney Cancer)
- Keywords
- Renal Cell Carcinoma, Partial nephrectomy, Radical nephrectomy, Preoperative planning, 3D virtual model, Virtual Reality
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- 2 Jun 2025 (estimated)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Jan 2026 (estimated)
- First posted
- 7 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Rationale:
Preoperative planning for both partial and radical nephrectomies using conventional CT imaging can be challenging due to complex renal anatomy and vascularization. 3D models in virtual reality (VR) may enhance anatomical understanding and improve preoperative planning. This study aims to prospectively evaluate the clinical impact of the use of 3D models in VR in the preoperative planning of partial and radical nephrectomies.
Objective:
The primary objective is to assess the impact of VR on preoperative planning and thereby on the agreement between the preoperative plan and the performed surgery in renal surgery (both partial and radical nephrectomies). The secondary objectives focus on the urologist's understanding of the anatomy and how the intraoperative and postoperative outcomes are influenced by the use of VR in the preoperative planning.
Study design:
The Virtual Renality study is a single-center randomized clinical trial conducted at the St. Antonius Hospital in Nieuwegein.
Study population:
The study population will consist of adult patients (18+) with a suspected RCC who are indicated for (partial) nephrectomy at St. Antonius Hospital Nieuwegein.
Intervention:
For the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the original CT scan during preoperative planning. For the control group, only the CT scan will be used for preoperative planning, according to the current standard of care.
Main study parameters/endpoints:
The primary study endpoint is the surgical concordance score, which describes the concordance between the actual performed surgery and the preoperatively determined surgical plan.
Nature and extent of the burden and risks associated with participation, benefit, and group relatedness:
Participation in this study will not require any additional physical examinations, blood samples, hospital visits, or questionnaires beyond standard clinical care. The only difference for participants in the intervention group is that a 3D model will be created from the existing CT scan and reviewed in VR during preoperative planning by the urologist.
Detailed description
The Virtual Renality study is a single-center randomized clinical trial conducted at the St. Antonius Hospital in Nieuwegein. For the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the original CT scan during preoperative planning, whereas for the control group, only the CT scan will be used for preoperative planning, according to the current standard of care. The flowchart in Figure 1 provides an overview of the study design. The steps covered in the flowchart and the collection of parameters will be further explained later in this protocol. The study is single-blinded, as the 3D virtual model during preoperative planning is the assessed intervention. Participants will be randomly assigned to either the control group or the intervention group to eliminate selection bias and achieve comparability between the two groups. The urologists who perform (partial) nephrectomies at the St. Antonius Hospital will participate in the study. A total of 72 patients suspected of having a renal tumor and indicated for (partial) nephrectomy will be included. The inclusion period for the study will take approximately 7 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Preoperative planning based on CT | No intervention | –For the control group the preoperative planning will be according to the current standard of care using only the CT scan. |
| Preoperative planning based on CT + VR | Experimental | Device: Virtual realityFor the intervention group, the urologist will review a 3D virtual model of the renal anatomy in addition to the CT scan during preoperative planning |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18+
- Suspected RCC and candidate for (partial) nephrectomy
- Signed informed consent
Key exclusion criteria (2 listed)
- Patients who are not approved to undergo surgery (due to comorbidities or their overall health condition)
- Patients who are unable to give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Virtual realityIf the participant is assigned to the intervention group a 3D virtual model will be constructed. For the intervention group the CT + VR will be reviewed during preoperative planning. | Device | Preoperative planning based on CT + VR |
Primary outcome
Concordance score between actual performed surgery and surgical plan
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
To assess whether the surgery is performed according to the preoperative plan, a questionnaire regarding the expected surgical steps will be completed during the preoperative planning. Postoperatively, the data will be collected from the surgical notes. The postoperative data will be compared with the preoperatively filled questionnaire and this will result in a concordance score between the actual performed surgery and the preoperatively determined surgical plan. This score of concordance will be the primary study endpoint
16 secondary outcomes
Intra-operative parameters: method of clamping
Time frame: Perioperative
Intraoperative parameters: blood loss
Time frame: Perioperative
Intraoperative parameters: clamping time
Time frame: Perioperative
Intraoperative parameters: opening of collecting system
Time frame: Perioperative
Intraoperative parameters: duration of surgery
Time frame: Perioperative
Post-operative parameters: renal function
Time frame: Up to 1 month post-surgery
Post-operative parameters: 30-day post-surgery complications
Time frame: 30 days post-surgery
Post-operative parameters: hospital stay
Time frame: 30-days post-surgery
Post-operative parameters: readmission (within 30 days)
Time frame: 30-days post-surgery
Post-operative parameters: clean resection margin
Time frame: 30-days post-surgery
Post-operative parameters:
Time frame: 30-days post-surgery
Understanding of anatomy - renal arteries
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of anatomy - renal veins
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of anatomy - collecting system
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of anatomy - tumor
Time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery
Understanding of anatomy - general anatomy
Time frame: during preoperative planning (approximately 3 days before surgery)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Virtual reality in people with Renal Cell Carcinoma (Kidney Cancer), run by St. Antonius Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 7 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Trouw, BSc (0031616501192, e.trouw@antoniusziekenhuis.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Concordance score between actual performed surgery and surgical plan (time frame: during preoperative planning (approximately 3 days before surgery) and immediately after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2025.