Comprehensive Prospective Comparison Of Two Robotic Platforms In Anatomical Lung Resections: Clinical Outcomes And Cost-utility Analysis (RATS_RYC)

April 16, 2026 updated by: Sara Fra Fernandez, Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

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:

  • 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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • Madrid
      • Madrid, Madrid, Spain, 28034
        • Hospital Universitario Ramon y Cajal

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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.

Description

Inclusion Criteria:

  • Patients that undergo segmentectomy or lobectomy with RATS.

Exclusion Criteria:

  • Conversion to VATS at the beginning of the procedure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Da Vinci
Patients undergoing anatomical lung resection (ALR) with DaVinci Xi
Device: da Vinci Xi Surgical System
Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)
Other Names:
  • Lobectomy
  • Segmentectomy
Versius
Patients undergoing anatomical lung resection (ALR) with Versius
Device: Versius Surgical System
Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)
Other Names:
  • Lobectomy
  • Segmentectomy

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).*
Data will be collected preoperatively (baseline), at 1, 3, 6, and 12 months after surgery.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Operation time
Time Frame: Perioperative/periprocedural
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
Perioperative/periprocedural
Conversions
Time Frame: Perioperative/periprocedural
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.
Perioperative/periprocedural
Complications
Time Frame: Within 30 days after surgery
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.
Within 30 days after surgery
Lymph nodes yielded
Time Frame: Perioperative/periprocedural
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.
Perioperative/periprocedural
Total cost
Time Frame: In-hospital (from the day of operation until the day of discharge)
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.
In-hospital (from the day of operation until the day of discharge)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 17, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 244/23

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

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