Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy (NCT06056505) | Clinical Trial Compass
CompletedNot Applicable
Virtual Interactive 3D Modelling to Improve Outcomes in Robotic-Assisted Partial Nephrectomy
Germany370 participantsStarted 2023-10-24
Plain-language summary
The primary objective is to determine if 3D modelling shortens total console operation time as a surrogate endpoint for clinical outcomes like perioperative complications and morbidity in robotic-assisted partial nephrectomy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients with kidney tumours ≤ 7cm and planned robotic-assisted partial nephrectomy with the DaVinci Surgical System
* CT scan with contrast medium available
* Age ≥ 18 years
* Written informed consent
Exclusion Criteria:
* History of surgery on affected kidney (e.g., partial nephrectomy, pyeloplasty, kidney cyst deroofing, percutaneous nephrolitholapaxy, radiofrequency ablation)
* Clinical suspicion of metastases (stage cN1/cM1)
* Horseshoe kidney
* Previous malignancy with ongoing or planned nephrotoxic chemotherapy
* Multifocal kidney tumour
* Von Hippel-Lindau syndrome and other hereditary kidney cancer syndromes
* Patient is immunosuppressed (e.g., organ transplantation, leukaemia)
* Tumor thrombus in Vena renalis or Vena cava inferior
* Severe cognitive impairment
* Pregnancy or lactation or women with desire for children
* Patients under legal supervision or guardianship
* Unable to give informed consent or suspected lack of compliance
* Patients who decline data collection and storage for the main study
What they're measuring
1
Primary endpoint is the console operation time measured intra-op.