Tumoral KidneyR3DP-PNCT06379698
Rein 3D PRINT PERSONALIZE
A study testing personalized 3D model pré-opérative education and generic 3D model pré-opérative education in people with Tumoral Kidney, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tumoral Kidney
- What is being tested?
- personalized 3D model pré-opérative education and generic 3D model pré-opérative education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 39 participants
- Where
- 1 siteFrance
- Study dates
- 28 May 2024to 15 Jun 2027
- 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
- Patients:
- Adult patients (≥ 18 years of age)
- Scheduled for surgical management by laparoscopic robotic-assisted partial nephrectomy (1st management for a unilateral or bilateral kidney tumor)
- Expressed consent for integration in the UroCCR database
- Expressed consent for participation in the Rein-3D Personalize study
- Patients affiliated or benefiting from social security system
Show all 9Show fewer
- Professionals:
- Professionals working with patients treated in the Urology, Andrology and Renal Transplant - Department of the Bordeaux University Hospital for at least two months prior to the implementation of 3D models
- Free, informed and signed consent
Who cannot join
- Patients
- Metastatic at inclusion
- Previous renal cancer(s)
- Single kidney at time of inclusion
- No preoperative CT scan, or poor-quality CT scan unable to provide reliable 3D modeling
- Person under legal protection (safeguard of justice, guardianship or curatorship)
Show all 10Show fewer
- Difficulty understanding and expressing oneself in French
- Professionals
- Professionals on internship lasting less than 6 months
- Professionals with no contact with patients
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Bordeaux
Bordeaux
Gaëlle MARGUE, Docteur
About this study
Official title: Effects of a Personalized or Generic Three-dimensional Tumoral Kidney Model on Patient Experience and Professional-patient Interactions, Before and After Partial Nephrectomy
The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers.
Read the detailed description
The use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in comprehensive care that is way not enough promoted for now.
A pilot study from 2015 demonstrated the benefits of using personalized 3D-printed kidney models as educational mediation tools during the pre-operative consultation of patients scheduled for robot-assisted partial nephrectomy. The patient's understanding of his pathology and of the surgery was thus facilitated, leading to greater satisfaction during treatment.
For personalized medicine, it is important to consider the heterogeneity in culture and social backgrounds of patients in the doctor-patient relationship. Measuring health literacy help to identify and describe this heterogeneity in patient profiles. Patients with low literacy levels have higher levels of anxiety, particularly regarding surgery, and poorer post-operative recovery. Some studies highlight the importance of improving patient understanding with strategies to improve patients' health literacy and information provided by carers.
The goal of this study is therefore to investigate the benefits of using a personalized 3D-printed kidney model versus a generic 3D-printed kidney model as a mediation tool, all along the care pathway, on patients' experience and their interactions with carers, before and after partial nephrectomy.
To achieve this aim, 60 patients planned for robot-assisted laparoscopic partial nephrectomy will be randomized, in a 1:1 ratio, between the use of a personalized 3D kidney model and a generic 3D kidney model.
3D models will be presented to the patients according to the allocated study group during a preoperative education consultation. All patients will complete questionnaires about their health literacy level, their knowledge of kidney anatomy and tumor and their satisfaction about the using 3D-printed kidney models as educational mediation tools. Semi-structured interviews will be conducted at three different times: between the first consultation with the surgeon and the preoperative education consultation, between this second consultation and the surgery and after the post-operative consultation.
- Conditions
- Tumoral Kidney
- Being tested
- personalized 3D model pré-opérative education, generic 3D model pré-opérative education
- Keywords
- Renal-Cell Carcinoma, Nephron-Sparing Surgery, 3D Model, 3D Printing, Personalized Medicine, Literacy Questionnaire
- Medical subject headings
- Carcinoma, Renal Cell
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
personalized 3D model pré-opérative educationOther
Before surgery, during a preoperative therapeutic education consultation, a personalized 3D models will be presented to the patients according to the allocated study group
generic 3D model pré-opérative educationOther
Before surgery, during a preoperative therapeutic education consultation, a generic 3D models will be presented to the patients according to the allocated study group
| Study group | Role | What they receive |
|---|---|---|
| personalized 3D kidney model | Active comparator | exchange time with the personalized 3D model of the kidney to be operated on as information support Receives: Other: personalized 3D model pré-opérative education |
| generic 3D kidney model | Active comparator | exchange time with the generic 3D model of the kidney to be operated on as information support Receives: Other: generic 3D model pré-opérative education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Qualitative assessment of patient experience 1
Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3.
Measurement of the progression in mean health literacy questionnaire score HLSEU-Q16 this questionnaire is a short version version of the European Health Literacy Survey Questionnaire (Sørensen et al., 2013), based on a model including 4 health information processing skills: accessing, understanding, evaluating and applying application of health information. The Items are scored from 'Strongly Disagree' to 'Strongly Agree', and from 'Cannot Do' to 'Very Easy'. The total score is produced by summing all items
Measured: between baseline and Day15 post-op
Qualitative assessment of patient experience 2
Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3.
Measurement of the level of understanding of renal anatomy and surgical issues using the Bernhard et al. questionnaire.
The knowledge questionnaire ( Bernhard 2016) consists of 4 parts: basic kidney physiology, basic kidney anatomy, tumor characteristics and planned surgical procedure. The patient answers 'False' , 'True' or 'Don't know'. The scores are calculated in each part by calculating the numbers of correct answers .
These dimensions will be studied before and after the presentation of the model, and compared according to the model used.;
Measured: between baseline and Day15 post-op
Qualitative assessment of patient experience 3
Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3.
Patient satisfaction is measured using the satisfaction questionnaire adapted from the Bernhard 2016 study. This measures how well the three-dimensional printed kidney model helped patients in learning " basic notions " about the kidney, and improving their understanding of : the disease, the scheduled surgery and the risk of complications related to the surgery. Each of the four dimensions is rated by a 10-point score ranging from 1 "no help at all" to 10 "great help". The average of the scores per dimension and an overall satisfaction score will be calculated and compared between the groups.
Measured: between baseline and Day15 post-op
Secondary outcomes (6)
Description of interactions between carers and patients
The description will be done according to the 3 D model used, specifying the aproach based on individual semi-directive interviews exploring patient experience, health education and health literacy as well as the vocabulary and content of the discourse employed.
Measured: between baseline and Day15 post-op
Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care.
The comparison will be done by evaluation of the evolution and frequency of terms used by patients : terms related to the pathology, the kidney model used, interactions with professionals in the care circuit
Measured: between baseline and Day15 post-op
Studying the use of the 3D-printed kidney model introduced during the medical information consultation up to the post-operative visit by describing the life of the model throughout the entire care process
Measured: between baseline and Day 15 post-op
To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model)
Level of understanding measured by the Bernhard et al questionnaire. This questionnaire consists of 4 parts: physiological and anatomical dimensions, knowledge of the disease and tumor characteristics, understanding of the surgical procedure and associated complication risks. These dimensions will be studied before and after the presentation of the model, and compared according to the model used. The final part of the questionnaire, based on an assessment of patient satisfaction, will be presented at the end of the post-operative consultation period
Measured: baseline ; between D-1 and Day-15 from surgery ; Day 15 post-op
Comparison of the level of health literacy between the two groups at different times with changes in the average score on the literacy questionnaire (HLSEU-Q16: European Health Literacy Survey Questionnaire)
This questionnaire is a short version version of the European Health Literacy Survey Questionnaire (Sørensen et al., 2013), based on a model including 4 health information processing skills: accessing, understanding, evaluating and applying application of health information . Patients respond on a 4 scale ranging from "very easy" to "very difficult". The overall score scales from 0 to 16 points. This score is used to determine 3 levels of literacy: unsatisfactory (0-8), average(9-12) and satisfactory (13-16).
Measured: baseline ; Day-30 post-op
Description of the changes perceived by carers in patients management in both group
Qualitatively assessment of changes in practices following the integration of 3D models into the department's practices. This analysis will be based on interviews with professionals, describing their relationship with patients and their families.
Measured: between baseline and year 1 post baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2024
- Study start28 May 2024
- Primary completion15 Jun 2027 (estimated)
- Study completion15 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tumoral KidneyStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 39 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gaëlle MARGUE, Docteur, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06379698
- Sponsor's protocol ID
- CHUBX 2023/78
- Acronym
- R3DP-P
- Status last verified
- Apr 2025
- First submitted
- 19 Mar 2024
- Last updated
- 22 Jun 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pattou M, Masanet S, Jutand MA, Hoarau H, Sarrazin J, Pitout A, Richert L, Larribere H, Rubat Baleuri F, Jaffredo M, Ricard S, Faessel M, Sabatier J, Bernhard JC, Margue G. Effects of a personalized or generic three-dimensional tumoral kidney model on patient experience and caregiver-patient interactions, before and after partial nephrectomy, a randomized trial (Rein 3D Print Personalize-UroCCR 114). PLoS One. 2025 Aug 18;20(8):e0323515. doi: 10.1371/journal.pone.0323515. eCollection 2025.
PubMed 40824885
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of a Personalized or Generic Three-dimensional Tumoral Kidney Model on Patient Experience and Professional-patient Interactions, Before and After Partial Nephrectomy
- ClinicalTrials.gov ID
- NCT06379698
- Acronym / sponsor ID
- R3DP-P / CHUBX 2023/78
- Conditions
- Tumoral Kidney
- Keywords
- Renal-Cell Carcinoma, Nephron-Sparing Surgery, 3D Model, 3D Printing, Personalized Medicine, Literacy Questionnaire
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 39 participants (estimated)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 28 May 2024 (actual)
- Primary completion
- 15 Jun 2027 (estimated)
- Study completion
- 15 Jun 2027 (estimated)
- First posted
- 23 Apr 2024 (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.
The goal of this clinical trial is to compare preoperative information and patient experience using a personalized versus a generic 3D printed models of patients' tumoral kidney before and after nephron-sparing surgery. The main outcome measure will be based on semi-structured interviews with the patient and the carers.
Detailed description
The use of tools to decrease anxiety and enhance understanding prior to surgery is a key point in comprehensive care that is way not enough promoted for now.
A pilot study from 2015 demonstrated the benefits of using personalized 3D-printed kidney models as educational mediation tools during the pre-operative consultation of patients scheduled for robot-assisted partial nephrectomy. The patient's understanding of his pathology and of the surgery was thus facilitated, leading to greater satisfaction during treatment.
For personalized medicine, it is important to consider the heterogeneity in culture and social backgrounds of patients in the doctor-patient relationship. Measuring health literacy help to identify and describe this heterogeneity in patient profiles. Patients with low literacy levels have higher levels of anxiety, particularly regarding surgery, and poorer post-operative recovery. Some studies highlight the importance of improving patient understanding with strategies to improve patients' health literacy and information provided by carers.
The goal of this study is therefore to investigate the benefits of using a personalized 3D-printed kidney model versus a generic 3D-printed kidney model as a mediation tool, all along the care pathway, on patients' experience and their interactions with carers, before and after partial nephrectomy.
To achieve this aim, 60 patients planned for robot-assisted laparoscopic partial nephrectomy will be randomized, in a 1:1 ratio, between the use of a personalized 3D kidney model and a generic 3D kidney model.
3D models will be presented to the patients according to the allocated study group during a preoperative education consultation. All patients will complete questionnaires about their health literacy level, their knowledge of kidney anatomy and tumor and their satisfaction about the using 3D-printed kidney models as educational mediation tools. Semi-structured interviews will be conducted at three different times: between the first consultation with the surgeon and the preoperative education consultation, between this second consultation and the surgery and after the post-operative consultation.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| personalized 3D kidney model | Active comparator | Other: personalized 3D model pré-opérative educationexchange time with the personalized 3D model of the kidney to be operated on as information support |
| generic 3D kidney model | Active comparator | Other: generic 3D model pré-opérative educationexchange time with the generic 3D model of the kidney to be operated on as information support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Adult patients (≥ 18 years of age)
- Scheduled for surgical management by laparoscopic robotic-assisted partial nephrectomy (1st management for a unilateral or bilateral kidney tumor)
- Expressed consent for integration in the UroCCR database
- Expressed consent for participation in the Rein-3D Personalize study
- Patients affiliated or benefiting from social security system
Key exclusion criteria (10 listed)
- Patients
- Metastatic at inclusion
- Previous renal cancer(s)
- Single kidney at time of inclusion
- No preoperative CT scan, or poor-quality CT scan unable to provide reliable 3D modeling
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 |
|---|---|---|
| personalized 3D model pré-opérative educationBefore surgery, during a preoperative therapeutic education consultation, a personalized 3D models will be presented to the patients according to the allocated study group | Other | personalized 3D kidney model |
| generic 3D model pré-opérative educationBefore surgery, during a preoperative therapeutic education consultation, a generic 3D models will be presented to the patients according to the allocated study group | Other | generic 3D kidney model |
Primary outcome
Qualitative assessment of patient experience 1
Time frame: between baseline and Day15 post-op
Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3. Measurement of the progression in mean health literacy questionnaire score HLSEU-Q16 this questionnaire is a short version version of the European Health Literacy Survey Questionnaire (Sørensen et al., 2013), based on a model including 4 health information processing skills: accessing, understanding, evaluating and applying application of health information. The Items are scored from 'Strongly Disagree' to 'Strongly Agree', and from 'Cannot Do' to 'Very Easy'. The total score is produced by summing all items
Qualitative assessment of patient experience 2
Time frame: between baseline and Day15 post-op
Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3. Measurement of the level of understanding of renal anatomy and surgical issues using the Bernhard et al. questionnaire. The knowledge questionnaire ( Bernhard 2016) consists of 4 parts: basic kidney physiology, basic kidney anatomy, tumor characteristics and planned surgical procedure. The patient answers 'False' , 'True' or 'Don't know'. The scores are calculated in each part by calculating the numbers of correct answers . These dimensions will be studied before and after the presentation of the model, and compared according to the model used.;
Qualitative assessment of patient experience 3
Time frame: between baseline and Day15 post-op
Patient experience will be measured by a set of element including observations and 3 questionnaires described in outcome 1, outcome 2, outcome 3. Patient satisfaction is measured using the satisfaction questionnaire adapted from the Bernhard 2016 study. This measures how well the three-dimensional printed kidney model helped patients in learning " basic notions " about the kidney, and improving their understanding of : the disease, the scheduled surgery and the risk of complications related to the surgery. Each of the four dimensions is rated by a 10-point score ranging from 1 "no help at all" to 10 "great help". The average of the scores per dimension and an overall satisfaction score will be calculated and compared between the groups.
6 secondary outcomes
Description of interactions between carers and patients
Time frame: between baseline and Day15 post-op
Comparison of the evolution and frequency of terms used by patients in the 2 groups during their care.
Time frame: between baseline and Day15 post-op
Studying the use of the 3D-printed kidney model introduced during the medical information consultation up to the post-operative visit by describing the life of the model throughout the entire care process
Time frame: between baseline and Day 15 post-op
To study the level of understanding of renal anatomy and surgical issues according to the type of tool (personalized vs generic 3D printed model)
Time frame: baseline ; between D-1 and Day-15 from surgery ; Day 15 post-op
Comparison of the level of health literacy between the two groups at different times with changes in the average score on the literacy questionnaire (HLSEU-Q16: European Health Literacy Survey Questionnaire)
Time frame: baseline ; Day-30 post-op
Description of the changes perceived by carers in patients management in both group
Time frame: between baseline and year 1 post baseline
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 22 Jun 2025.
- Derived from this study: PubMed 40824885Pattou M, Masanet S, Jutand MA, Hoarau H, Sarrazin J, Pitout A, Richert L, Larribere H, Rubat Baleuri F, Jaffredo M, Ricard S, Faessel M, Sabatier J, Bernhard JC, Margue G. Effects of a personalized or generic three-dimensional tumoral kidney model on patient experience and caregiver-patient interactions, before and after partial nephrectomy, a randomized trial (Rein 3D Print Personalize-UroCCR 114). PLoS One. 2025 Aug 18;20(8):e0323515. doi: 10.1371/journal.pone.0323515. eCollection 2025.
- Individual participant dataSharing planned: No
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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.
Gaëlle MARGUE, Docteur principal investigator
University Hospital, Bordeaux
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing personalized 3D model pré-opérative education and generic 3D model pré-opérative education in people with Tumoral Kidney, run by University Hospital, Bordeaux at 1 site in France.
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 9 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 22 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Gaëlle MARGUE, Dr (00335 57 82 17 62, gaelle.margue@chu-bordeaux.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Qualitative assessment of patient experience 1 (time frame: between baseline and Day15 post-op). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06379698, which also lists 1 linked publication.
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 22 Jun 2025.