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RecruitingNCT06038227

Lung cAncer Robotic Comparative Study

Comparing Outcomes for Minimally Invasive Techniques for Anatomic Lung Resection for Cancer - A Prospective, Comparative, Non-randomized, Open Label Post-market Observational Cohort Study Within Europe

Sponsor

Intuitive Surgical

Enrollment

512 participants

Start Date

Jul 15, 2023

Study Type

OBSERVATIONAL

Conditions

Lung Cancer

Summary

To compare outcomes of minimally invasive surgical techniques for the treatment of early-stage non-small cell lung cancer.

Eligibility

Min Age: 18 Years

Inclusion Criteria5

  • Patient diagnosed with clinical stage IA1-2 non-small cell lung cancer at time of procedure
  • Patient scheduled to undergo minimally invasive surgery for NSCLC with either da Vinci robotic assisted surgery or VATs
  • Aged ≥ 18 years
  • Must be willing and able to comply with study requirements
  • Must indicate their understanding of the study and willingness to participate by signing an appropriate informed consent form

Exclusion Criteria9

  • Patients with clinical stage IA3, II, III, and IV lung cancer
  • Patient receiving a lobectomy/segmentectomy as an emergency procedure
  • Patients receiving a lobectomy/segmentectomy for metastatic cancer
  • Patients scheduled to receive a bilobectomy or sleeve-lobectomy
  • Mental incapacity to understand or consent to study procedures
  • Anticipated difficulty for patient to comply with protocol requirements
  • Unable to comply with the follow up schedule
  • Pregnant or are planning to become pregnant during the study
  • Life expectancy \< 12 months

Interventions

PROCEDURERobotic Assisted Thoracic Surgery

Surgeons will pre-determine to perform a segmentectomy or lobectomy using RATS.

PROCEDUREVideo Assisted Thoracic Surgery

Surgeons will pre-determine to perform a segmentectomy or lobectomy using VATS.

Locations(11)

AP-HM

Marseille, France

CHU de Rouen

Rouen, France

CHU de Toulouse

Toulouse, France

Thoraxklinik

Heidelberg, Germany

Krankenhaus Barmherzige Brüder

Regensburg, Germany

Azienda Ospedaliero Universitaria Pisana

Pisa, Italy

Akershus University Hospital

Loerenskog, Norway

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, United Kingdom

University Hospitals Coventry and Warwickshire NHS Trust

Coventry, United Kingdom

Guy's and St Thomas' NHS Foundation Trust

London, United Kingdom

St Bartholomew Hospital

London, United Kingdom

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