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NCT05572216Recruiting

A CCafU-UroCCR Randomized Trial: 3D Image-Guided Robot-AssisTEd Partial Nephrectomy for Renal Complex Tumor (UroCCR N°99)

Source: ClinicalTrials.gov · Last updated 18 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

The goal of this clinical trial is to evaluate peri and post-operative outcomes as well as long-term survival of 3D IGRAPN compared to conventional Robot-Assisted Partial Nephrectomy (RAPN) for moderate and highly complex renal tumors. The main questions aim to answer: * peri-operative complications * oncological safety * long term renal function Participants will be asked to do undergo 3D-IGRAPN. Researchers will compare 3D-IGRAPN to RAPN to see if peri-operative outcomes are better in the experimental group.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
694 (estimated)
First submitted
5 Oct 2022
Start date
24 Jan 2023
Primary completion date
24 Jan 2023
Lead sponsor
University Hospital, Grenoble
NCT number
NCT05572216

What you commit to

  • Study type: Interventional
  • Planned participants: 694
  • From 24 Jan 2023 to the primary completion date, 24 Jan 2023
  • 2 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Other illness

  • Renal insufficiency forbidding iodine injection
  • Patient with allergy to iodinated contrast products

Other

  • Medical contraindication to RAPN
  • Patient concerned by articles L1121-5 to 8 of the French public health code (protected persons)

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (2)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
university Hospital Grenoble
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting
university HospitalGrenoble
Coordinator of this site? Confirm its status
GrenobleFranceRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.