Pulmonary Nodule, SolitaryRATS_RYCNCT07537556
Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost-utility Analysis
An observational study of Pulmonary Nodule, Solitary and Lung Cancer (NSCLC), run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
Trial summary
The goal is to compare clinical outcomes, hospital costs, and cost-utility in patients undergoing anatomical lung resections with DaVinci Xi vs Versius platforms The main questions it aims to answer are: Do patients that undergo an anatomical lung resection with DaVinci Xi have the same clinical outcomes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Nodule, Solitary, Lung Cancer (NSCLC), Pulmonary Metastases
- What is being tested?
- da Vinci Xi Surgical System and Versius Surgical System
- Type of treatment
- Medical device
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- 1 Apr 2023to 31 Jul 2026
- How long will I take part?
- 1 Year
- Phase
- Observational
- 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
Study population: Adult patients undergoing elective thoracic surgery at a tertiary referral hospital will be considered for inclusion. The study population will consist of patients scheduled for pulmonary resection for suspected or confirmed malignant lung disease.
Who may be able to join
- Patients that undergo segmentectomy or lobectomy with RATS.
Who cannot join
- Conversion to VATS at the beginning of the procedure
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost-utility Analysis.
The goal is to compare clinical outcomes, hospital costs, and cost-utility in patients undergoing anatomical lung resections with DaVinci Xi vs Versius platforms
The main questions it aims to answer are:
Read more
- Do patients that undergo an anatomical lung resection with DaVinci Xi have the same clinical outcomes (complications, stay...) than those who were operated with Versius?
- Are anatomical lung resections performed with DaVinci Xi more expensive than those performed with Versius?
- Are anatomical lung resection performed with DaVinci Xi more cost-effective than those performed with Versius?
Participants already undergoing robotic anatomical lung resection as part of their regular medical care will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.
- Being tested
- da Vinci Xi Surgical System, Versius Surgical System
- Keywords
- RATS, Da Vinci, Versius, Lung resection
- Medical subject headings
- Solitary Pulmonary Nodule, Lung Neoplasms, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
da Vinci Xi Surgical SystemDevice
Also called Lobectomy, Segmentectomy
Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)
Versius Surgical SystemDevice
Also called Lobectomy, Segmentectomy
Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)
| Study group | Role | What they receive |
|---|---|---|
| Da Vinci | Patients undergoing anatomical lung resection (ALR) with DaVinci Xi Receives: Device: da Vinci Xi Surgical System | |
| Versius | Patients undergoing anatomical lung resection (ALR) with Versius Receives: Device: Versius Surgical System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cost/utility ratio
The cost/utility ratio will be calculated as the incremental cost per quality-adjusted life year (QALY) gained, comparing robotic-assisted thoracic surgery (RATS) with Da Vinci Xi and Versius. Costs will include all direct procedural costs (including consumables, reusable instruments, operating room time, and maintenance costs of equipment), as well as postoperative hospital-related costs. Health outcomes will be expressed in QALYs, derived from validated health-related quality of life measures collected during follow-up. The analysis will be conducted from the healthcare system perspective, and results will be expressed as an incremental cost-effectiveness ratio (ICER).*
Measured: Data will be collected preoperatively (baseline), at 1, 3, 6, and 12 months after surgery.
Secondary outcomes (5)
Operation time
Operation time will be defined as the duration of the surgical procedure, measured in minutes from skin incision to skin closure. This variable will be compared between Da Vinci Xi and Versius
Measured: Perioperative/periprocedural
Conversions
Conversion rate will be defined as the need to convert from RATS to VATS or open thoracotomy during the procedure. The proportion of conversions will be recorded and compared between groups.
Measured: Perioperative/periprocedural
Complications
Postoperative complications will be defined as any adverse events occurring within 30 days after surgery. Complications will be recorded prospectively and classified according to a standardized grading system (e.g., Clavien-Dindo classification). Both overall complication rates and severity grades will be analyzed and compared between groups.
Measured: Within 30 days after surgery
Lymph nodes yielded
Lymph node yield will be defined as the total number of lymph nodes resected and retrieved during surgery, as reported in the pathological examination. This variable will be used as a surrogate of oncological quality and compared between Da Vinci and Versius groups.
Measured: Perioperative/periprocedural
Total cost
Total cost will include all direct hospital-related costs associated with the procedure and postoperative care. This encompasses consumables, reusable equipment (with cost allocation), operating room time, hospital stay, and any costs derived from complications or readmissions.
Measured: In-hospital (from the day of operation until the day of discharge)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2026
- Study start1 Apr 2023
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Nodule, SolitaryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Fra Fernandez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07537556
- Sponsor's protocol ID
- 244/23
- Acronym
- RATS_RYC
- Status last verified
- Apr 2026
- First submitted
- 7 Apr 2026
- Last updated
- 17 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost-utility Analysis.
- ClinicalTrials.gov ID
- NCT07537556
- Acronym / sponsor ID
- RATS_RYC / 244/23
- Keywords
- RATS, Da Vinci, Versius, Lung resection
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 17 Apr 2026 (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 is to compare clinical outcomes, hospital costs, and cost-utility in patients undergoing anatomical lung resections with DaVinci Xi vs Versius platforms
The main questions it aims to answer are:
- Do patients that undergo an anatomical lung resection with DaVinci Xi have the same clinical outcomes (complications, stay...) than those who were operated with Versius?
- Are anatomical lung resections performed with DaVinci Xi more expensive than those performed with Versius?
- Are anatomical lung resection performed with DaVinci Xi more cost-effective than those performed with Versius?
Participants already undergoing robotic anatomical lung resection as part of their regular medical care will answer quality of life questionnaires preoperatively, at 1, 3, 6, and 12 months after surgery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Da Vinci | – | Device: da Vinci Xi Surgical SystemPatients undergoing anatomical lung resection (ALR) with DaVinci Xi |
| Versius | – | Device: Versius Surgical SystemPatients undergoing anatomical lung resection (ALR) with Versius |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients undergoing elective thoracic surgery at a tertiary referral hospital will be considered for inclusion. The study population will consist of patients scheduled for pulmonary resection for suspected or confirmed malignant lung disease.
Key inclusion criteria (1 listed)
- Patients that undergo segmentectomy or lobectomy with RATS.
Key exclusion criteria (1 listed)
- Conversion to VATS at the beginning of the procedure
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 |
|---|---|---|
| da Vinci Xi Surgical SystemAlso: Lobectomy, SegmentectomyRobotic platform used to perform anatomical lung resection (lobectomy or segmentectomy) | Device | Da Vinci |
| Versius Surgical SystemAlso: Lobectomy, SegmentectomyRobotic platform used to perform anatomical lung resection (lobectomy or segmentectomy) | Device | Versius |
Primary outcome
Cost/utility ratio
Time frame: Data will be collected preoperatively (baseline), at 1, 3, 6, and 12 months after surgery.
The cost/utility ratio will be calculated as the incremental cost per quality-adjusted life year (QALY) gained, comparing robotic-assisted thoracic surgery (RATS) with Da Vinci Xi and Versius. Costs will include all direct procedural costs (including consumables, reusable instruments, operating room time, and maintenance costs of equipment), as well as postoperative hospital-related costs. Health outcomes will be expressed in QALYs, derived from validated health-related quality of life measures collected during follow-up. The analysis will be conducted from the healthcare system perspective, and results will be expressed as an incremental cost-effectiveness ratio (ICER).*
5 secondary outcomes
Operation time
Time frame: Perioperative/periprocedural
Conversions
Time frame: Perioperative/periprocedural
Complications
Time frame: Within 30 days after surgery
Lymph nodes yielded
Time frame: Perioperative/periprocedural
Total cost
Time frame: In-hospital (from the day of operation until the day of discharge)
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 17 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Pulmonary Nodule, Solitary
RecruitingObservational study
Biomarkers for Risk Stratification in Lung Cancer
Nodule Solitary Pulmonary, Non-small Cell Lung Cancer
RecruitingObservational study
European Real-World Registry for Use of the Ion Endoluminal System
Pulmonary Nodule, Lung Cancer
Recruiting
Intraoperative Longitude-Latitude-Depth Localization Versus Preoperative CT-Guided Percutaneous Lung Puncture Localization for 0.8-2 cm Peripheral Pulmonary Nodules
Pulmonary Nodule, Solitary, Peripheral Pulmonary Nodules
Not yet recruitingObservational study
Radiomics for Distinguishing Benign and Malignant Lung Nodules
Solitary Pulmonary Nodule, Lung Neoplasms
Active, not recruiting
Teachable Moment to Opt-out of Tobacco: Interactive Voice Response Quit Line for Veteran Active Smokers With Lung Nodules
Solitary Pulmonary Nodule, Multiple Pulmonary Nodules
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Nodule, Solitary and Lung Cancer (NSCLC), run by Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal at 1 site in Spain.
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 1 inclusion and 1 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: under way, not looking for participants, as of the sponsor's last update on 17 Apr 2026. 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 Spain. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cost/utility ratio (time frame: Data will be collected preoperatively (baseline), at 1, 3, 6, and 12 months after surgery.). 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 17 Apr 2026.