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

NCT07537556 | Active Not Recruiting FDA Device

• 1 other identifier: 244/23
• Study Type: observational
• Target: 150
• Locations: 1 country
• Sites: 1

Brief 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 (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.

Conditions

Pulmonary Nodule, Solitary; Lung Cancer (NSCLC); Pulmonary Metastases

Keywords

RATS; Da Vinci; Versius; Lung resection

Outcome Measures

Primary Outcomes (1)

• 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).\*

  Data will be collected preoperatively (baseline), at 1, 3, 6, and 12 months after surgery.

Secondary Outcomes (5)

• Operation time

  Perioperative/periprocedural

• Conversions

  Perioperative/periprocedural

• Complications

  Within 30 days after surgery

• Lymph nodes yielded

  Perioperative/periprocedural

• Total cost

  In-hospital (from the day of operation until the day of discharge)

Study Arms (2)

Da Vinci

Patients undergoing anatomical lung resection (ALR) with DaVinci Xi

Device: da Vinci Xi Surgical System

Versius

Patients undergoing anatomical lung resection (ALR) with Versius

Device: Versius Surgical System

Interventions

da Vinci Xi Surgical System DEVICE

Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)

Also known as: Lobectomy, Segmentectomy

Da Vinci

Versius Surgical System DEVICE

Robotic platform used to perform anatomical lung resection (lobectomy or segmentectomy)

Also known as: Lobectomy, Segmentectomy

Versius

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Patients that undergo segmentectomy or lobectomy with RATS.

You may not qualify if:

• Conversion to VATS at the beginning of the procedure

Sponsors & Collaborators

• Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y Cajal: lead

Study Sites (1)

Hospital Universitario Ramón y Cajal

Madrid, Madrid, 28034, Spain

Location

MeSH Terms

Conditions

Solitary Pulmonary Nodule; Lung Neoplasms; Carcinoma, Non-Small-Cell Lung

Interventions

Anterior Temporal Lobectomy; Mastectomy, Segmental

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Carcinoma, Bronchogenic; Bronchial Neoplasms

Intervention Hierarchy (Ancestors)

Surgical Procedures, Operative; Neurosurgical Procedures; Mastectomy

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: April 7, 2026
• First Posted: April 17, 2026
• Study Start: April 1, 2023
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04

Locations

ES (1)