Renal CarcinomaCOMPAR-KNCT06290427
Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney (COMPAR-K)
A study testing DaVinci RAPN and Hugo RAS RAPN in people with Renal Carcinoma, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
Trial summary
The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms: DaVinci®; Hugo®. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Carcinoma
- What is being tested?
- DaVinci RAPN and Hugo RAS RAPN
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteItaly
- Study dates
- 1 Feb 2024to Jun 2025
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patient aged between 18 and 90 years old;
- patient with localized kidney tumor suitable for partial nephrectomy;
- patient able to understand and sign the informed consent;
- patient compliance with the follow-up program.
Who cannot join
- patient who do not fall within the inclusion age range;
- patient not suitable for partial nephrectomy;
- patient unable to understand and sign the informed consent;
- patient unable to follow the monitoring program;
- patient refusal to participate to the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Urology Unit, AOUI Verona
Verona, VR, 37126
Alessandro AA Antonelli, MD, +39 0458127701, alessandro.antonelli@aovr.veneto.it
Unità Ricerca Clinica, +39 0458122844, unita.ricerca.clinica@aovr.veneto.it
About this study
Official title: Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney
The Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms:
- DaVinci®;
- Hugo®.
The questions it aims to answer are:
Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?
Participants will be invited to join one of these two experimental group:
- surgery with the DaVinci platform;
- surgery with the Hugo platform.
- Conditions
- Renal Carcinoma
- Being tested
- DaVinci RAPN, Hugo RAS RAPN
- Keywords
- Robotic-assisted surgery, Partial Nephrectomy, Multiple surgical platforms, Postoperative complications, Operative outcomes
- Medical subject headings
- Carcinoma, Renal Cell, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DaVinci RAPNDevice
Robot-assisted Partial Nephrectomy with DaVinci® Surgical System
Hugo RAS RAPNDevice
Robot-assisted Partial Nephrectomy with Hugo™ RAS System
| Study group | Role | What they receive |
|---|---|---|
| DaVinci system | Active comparator | Robot-assisted partial nephrectomy is performed using the DaVinci platform Receives: Device: DaVinci RAPN |
| Hugo RAS system | Experimental | Robot-assisted partial nephrectomy is performed using the Hugo RAS platform Receives: Device: Hugo RAS RAPN |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with postoperative complications
Overall postoperative complications (% score >0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Measured: Over the 4 days post surgery
Number of participants with moderate to major postoperative complications
Moderate to major complications (% score >=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Measured: Over the 4 days post surgery
Number of participants with major postoperative complications
Major complications (% score >=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Measured: Over the 4 days post surgery
Secondary outcomes (13)
Overall duration of the surgery
Minutes
Measured: Intraoperative
Number of intraoperative complications
Proportion of events
Measured: Intraoperative
Type of intraoperative complications
Note of the event detail
Measured: Intraoperative
Number of intraoperative technical malfunctions
Proportion of events
Measured: Intraoperative
Type of intraoperative technical malfunctions
Note of the event detail
Measured: Intraoperative
Estimated Blood Loss
Volume
Measured: Intraoperative
Postoperative hospitalization
Days of recovery until the date of discharge
Measured: From the day after surgery up to 10 days postoperative
Postoperative pain
Numerical Rating Scale (NRS) 0-10 scale for the self-reported rate of pain: zero meaning "no pain" and 10 meaning "the worst pain imaginable"
Measured: 1-4 days postoperative
Positive Surgical Margins
Rate after histological examination
Measured: Up to 2 weeks postoperative (at the end of histological analysis)
Serum Creatinine dosage for renal function assessment
Creatinine test
Measured: 1 month, 3 and 6 months follow-up
Estimated Glomerular Filtration Rate for renal function assessment
eGFR calculation estimated by EPI-CKD formula
Measured: 1 month, 3 and 6 months follow-up
Time taken for platform related timings
Configuration of the surgical table, Draping, Undraping, Docking, Undocking
Measured: From the room setting, through the overall surgical procedure, until postoperative room restoration for each of expected 45 surgeries (through study completion: about 4 months)
Procedure-related costs
Estimate
Measured: From surgical procedure to the end of follow-up period (6 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2024
- Study start1 Feb 2024
- Primary completion12 Dec 2024
- Study completionJun 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal CarcinomaStudies 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata Verona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alessandro Antonelli, MD, Prof, Azienda Ospedaliera Universitaria Integrata Verona
- Investigators
- Alessandro AA Antonelli, MD, Principal investigator, Azienda Ospedaliera Universitaria Integrata Verona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06290427
- Sponsor's protocol ID
- COMPAR-K
- Acronym
- COMPAR-K
- Status last verified
- Jan 2025
- First submitted
- 21 Feb 2024
- Last updated
- 3 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcomes of Multiple Platforms for Assisted Robotic-Kidney
- ClinicalTrials.gov ID
- NCT06290427
- Acronym / sponsor ID
- COMPAR-K / COMPAR-K
- Conditions
- Renal Carcinoma
- Keywords
- Robotic-assisted surgery, Partial Nephrectomy, Multiple surgical platforms, Postoperative complications, Operative outcomes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Universitaria Integrata VeronaUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 12 Dec 2024 (actual)
- Study completion
- Jun 2025 (estimated)
- First posted
- 4 Mar 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 Urology Unit of AOUI Verona proposes a clinical study aimed at a preliminary evaluation of postoperative complications specifically focused on robotic partial nephrectomy (RAPN) procedures using two currently available platforms:
- DaVinci®;
- Hugo®.
The questions it aims to answer are:
Does the estimation of the post-operative complications suggest something? Are differences (intra- and post-operative, oncological, functional, technical, and economic) among the three intervention approaches observable?
Participants will be invited to join one of these two experimental group:
- surgery with the DaVinci platform;
- surgery with the Hugo platform.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| DaVinci system | Active comparator | Device: DaVinci RAPNRobot-assisted partial nephrectomy is performed using the DaVinci platform |
| Hugo RAS system | Experimental | Device: Hugo RAS RAPNRobot-assisted partial nephrectomy is performed using the Hugo RAS platform |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- patient aged between 18 and 90 years old;
- patient with localized kidney tumor suitable for partial nephrectomy;
- patient able to understand and sign the informed consent;
- patient compliance with the follow-up program.
Key exclusion criteria (5 listed)
- patient who do not fall within the inclusion age range;
- patient not suitable for partial nephrectomy;
- patient unable to understand and sign the informed consent;
- patient unable to follow the monitoring program;
- patient refusal to participate to the study.
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 |
|---|---|---|
| DaVinci RAPNRobot-assisted Partial Nephrectomy with DaVinci® Surgical System | Device | DaVinci system |
| Hugo RAS RAPNRobot-assisted Partial Nephrectomy with Hugo™ RAS System | Device | Hugo RAS system |
Primary outcome
Number of participants with postoperative complications
Time frame: Over the 4 days post surgery
Overall postoperative complications (% score >0) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Number of participants with moderate to major postoperative complications
Time frame: Over the 4 days post surgery
Moderate to major complications (% score >=2) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
Number of participants with major postoperative complications
Time frame: Over the 4 days post surgery
Major complications (% score >=3) are considered by Clavien-Dindo Classification 7 grades (I, II, IIIa, IIIb, IVa, IVb and V): the higher the grade, the higher the severity of the complication
13 secondary outcomes
Overall duration of the surgery
Time frame: Intraoperative
Number of intraoperative complications
Time frame: Intraoperative
Type of intraoperative complications
Time frame: Intraoperative
Number of intraoperative technical malfunctions
Time frame: Intraoperative
Type of intraoperative technical malfunctions
Time frame: Intraoperative
Estimated Blood Loss
Time frame: Intraoperative
Postoperative hospitalization
Time frame: From the day after surgery up to 10 days postoperative
Postoperative pain
Time frame: 1-4 days postoperative
Positive Surgical Margins
Time frame: Up to 2 weeks postoperative (at the end of histological analysis)
Serum Creatinine dosage for renal function assessment
Time frame: 1 month, 3 and 6 months follow-up
Estimated Glomerular Filtration Rate for renal function assessment
Time frame: 1 month, 3 and 6 months follow-up
Time taken for platform related timings
Time frame: From the room setting, through the overall surgical procedure, until postoperative room restoration for each of expected 45 surgeries (through study completion: about 4 months)
Procedure-related costs
Time frame: From surgical procedure to the end of follow-up period (6 months)
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 3 Jan 2025.
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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.
Alessandro AA Antonelli, MD principal investigator
Azienda Ospedaliera Universitaria Integrata Verona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing DaVinci RAPN and Hugo RAS RAPN in people with Renal Carcinoma, run by Azienda Ospedaliera Universitaria Integrata Verona at 1 site in Italy.
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 4 inclusion and 5 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 3 Jan 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 Italy. 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 Alessandro AA Antonelli, MD (+39 0458127701, alessandro.antonelli@aovr.veneto.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with postoperative complications (time frame: Over the 4 days post surgery). 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?
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 3 Jan 2025.