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Studies

Observational Recruiting

NCT06038227 on ClinicalTrials.gov

Lung cAncer Robotic Comparative Study

Official title: 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 (Group)
  • Enrollment: 600 (Estimated)
  • Study start: 2023-07-15 (Actual)
  • Primary completion: 2027-12-30 (Estimated)
  • Study completion: 2027-12-30 (Estimated)
  • Allocation: N/a
  • InterventionModel: N/a
  • Masking: None
  • PrimaryPurpose: Other

Brief Summary

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

Conditions

  • Lung Cancer

Intervention / Treatment

  • Procedure: Robotic Assisted Thoracic Surgery
  • Procedure: Video Assisted Thoracic Surgery

Primary Outcome Measures

  • Patient reported Quality of Life 1 (1 month post surgery)
    EQ 5D 5L (European Quality of Life Five Dimension) The EQ-5D-5L is a validated and established generic Patient Reported Outcome (PRO) instrument that uses 6 questions to assess patients' quality of life. It includes a vertical EQ visual analog scale (EQ VAS, 0-100 points) and a descriptive EQ-5D-5L system. An algorithm is used to calculate the scores. For the descriptive section of the scale, an index value of 1 represents the best possible health state, while an index value of \<0 (variable) represents the worst possible health state. The EQ VAS score is rated on a scale of 0-100 points. 0 points correspond to the worst possible health status, while 100 points correspond to the best possible health status.
  • Patient reported Quality of Life 2 (1 month post surgery)
    RNLI (Reintegration to Normal Living Index) The RNLI has 11 questions and is scored on a visual analogue scale (VAS). On one end: "does not describe my situation" (1 or minimal integration) and "fully describes my situation" (10 or complete integration). Individual item scores are summed to provide the total score. The higher the score, the better the patients perceived integration.

Countries

Denmark, France, Germany, Italy, Norway, Switzerland, United Kingdom

Locations and Investigators

  • Copenhagen University Hospital Rigshospitalet, Copenhagen, Denmark (Recruiting)
    • Rene Petersen
    • Rene Petersen (Principal Investigator)
  • AP-HM, Marseille, France (Recruiting)
  • CHU de Rouen, Rouen, France (Recruiting)
  • CHU de Toulouse, Toulouse, France (Recruiting)
    • Laurent Brouchet
    • Laurent Brouchet (Principal Investigator)
  • Thoraxklinik, Heidelberg, Germany (Recruiting)
    • Martin Eichhorn
    • Martin Eichhorn (Principal Investigator)
  • Krankenhaus Barmherzige Brüder, Regensburg, Germany (Recruiting)
    • Hans-Stefan Hofmann
    • Hans-Stefan Hofmann (Principal Investigator)
  • Azienda Ospedaliero Universitaria Pisana, Pisa, Italy (Recruiting)
    • Carmelina Cristina, Zirafa
    • Carmelina Cristina Zirafa (Principal Investigator)
  • Akershus University Hospital, Loerenskog, Norway (Recruiting)
    • Rune, Eggum
    • Rune Eggum (Principal Investigator)
  • University Hospital Zurich, Zurich, Switzerland (Recruiting)
    • Isabelle Schmitt-Opitz
    • Isabelle Schmitt-Opitz (Principal Investigator)
  • University Hospitals Bristol and Weston NHS Foundation Trust, Bristol, United Kingdom (Recruiting)
    • Igor Saftic
    • Igor Saftic (Principal Investigator)
  • University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom (Recruiting)
    • Luis Hernandez
    • Luis Hernandez (Principal Investigator)
  • Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom (Recruiting)
    • Tom Routledge
    • Tom Routledge (Principal Investigator)
  • St Bartholomew Hospital, London, United Kingdom (Recruiting)
    • Steven Stamenkovic
    • Steven Stamenkovic (Principal Investigator)

Study Officials

  • Tom Routledge (Principal Investigator) — Guy's St Thomas' NHS Foundation Trust, UK
  • Rune Eggum (Principal Investigator) — University Hospital, Akershus
  • Martin Eichhorn (Principal Investigator) — Thoraxklinik Heidelberg, Germany