3D image-guided robot-assisted surgery for complex kidney tumors
A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)
NA · University Hospital, Grenoble · NCT05572216
This study is testing a new robot-assisted surgery technique for complex kidney tumors to see if it leads to fewer complications and better long-term kidney function compared to the standard method.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 694 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Grenoble (other) |
| Locations | 2 sites (Grenoble and 1 other locations) |
| Trial ID | NCT05572216 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the outcomes of a new surgical technique called 3D Image-Guided Robot-Assisted Partial Nephrectomy (3D IG-RAPN) compared to the conventional Robot-Assisted Partial Nephrectomy (RAPN) for patients with moderate to highly complex renal tumors. The study aims to assess peri-operative complications, oncological safety, and long-term renal function preservation. Participants will undergo the experimental procedure, and researchers will analyze the results to determine if the new approach offers better outcomes. The trial will be conducted across 12 high-volume urological centers within the UroCCR Network.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 with moderate or high complexity renal tumors who are eligible for robot-assisted surgery.
Not a fit: Patients with medical contraindications to robot-assisted surgery or those with renal insufficiency that prevents iodine injection may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to improved surgical outcomes and long-term health for patients with complex renal tumors.
How similar studies have performed: While the use of augmented reality in surgery is an emerging field, this specific approach has not been widely tested, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients over 18 years * Indication of RAPN for suspicious renal tumor * Moderate or high complexity renal tumor (RENAL Nephrometry Score (NS) \>7) * Da Vinci® surgical system available for the surgery * Patient affiliated to the French social security system or an equivalent system * Signed informed consent form UroCCR and ACCURATE Exclusion Criteria: * Medical contraindication to RAPN * Renal insufficiency forbidding iodine injection * Patient with allergy to iodinated contrast products * Patient concerned by articles L1121-5 to 8 of the French public health code (protected persons)
Where this trial is running
Grenoble and 1 other locations
- University Hospital Grenoble — Grenoble, France (RECRUITING)
- university HospitalGrenoble — Grenoble, France (RECRUITING)
Study contacts
- Principal investigator: Jean-Luc DESCOTES, Pr — University Hospital, Grenoble
- Study coordinator: Jean-Luc DESCOTES, Pr
- Email: jldescotes@chu-grenoble.fr
- Phone: 0476767642
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Renal Tumor, Renal Cancer, image guidance, augmented reality, robotics