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NCT06035211Recruiting

Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery- Rein 3D Anxiety

Effect on Pre-operative Anxiety of a Personalized Three-dimensional Kidney Model Prior to Nephron-sparing Surgery for Renal Tumor. R3DP-A

Source: ClinicalTrials.gov · Last updated 15 Jun 2025 · 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 the impact of showing and handling a three-dimensional modelization of a patient's tumoral kidney the day before his nephron-sparing surgery. The main outcome measure was the effect on anxiety assessed via the STAI state score. 3 types of pre-operative information were compared (3D virtual model, 3D printed model, and information) using a randomization.

Status (registry)
Recruiting
Study type
Interventional
Enrollment
192 (estimated)
First submitted
28 Aug 2023
Start date
19 Sept 2023
Primary completion date
19 Sept 2025
Lead sponsor
University Hospital, Bordeaux
NCT number
NCT06035211

What you commit to

  • Study type: Interventional
  • Planned participants: 192
  • From 19 Sept 2023 to the primary completion date, 19 Sept 2025
  • 6 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

  • Refusal of consent or participation
  • Difficulty understanding and expressing oneself in French
  • Patient under guardianship or curatorship
  • No preoperative CT scan available for 3D modeling

Who the study is looking for

  • Adult patients (≥ 18 years of age)
  • Scheduled surgical management by laparoscopic partial nephrectomy with robotic assistance for kidney tumor
  • Unilateral kidney tumor or 1st surgery for bilateral involvement
  • Consent expressed for integration of the UroCCR cohort,
  • Expressed consent for participation in the 3D Anxiety study.
  • Patients affiliated or benefiting from a social security plan

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

Full criteria on ClinicalTrials.gov

Sites (6)

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

SiteCityCountrySite status
CHU d Angers
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AngersFranceRecruiting
CHU de Bordeaux
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BordeauxFranceRecruiting
CHU de CAEN
Coordinator of this site? Confirm its status
CaenFranceRecruiting
Hôpital Kremlin-Bicêtre
Coordinator of this site? Confirm its status
Le Kremlin-BicêtreFranceRecruiting
CHU de La CONCEPTION
Coordinator of this site? Confirm its status
MarseilleFranceRecruiting
CHU de Nantes
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NantesFranceRecruiting

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