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NCT Number: NCT06348030

Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung resection enables the operating surgeon to perform the case independently, but its implication on costs and patient outcomes remains unknown. There also is, however, a lack of prospective research evaluating the costs of the two methods for dissection and vessel sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels <7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system.

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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location contact

Waël C Hanna, MDCM, MBA, FRCSC

PRINCIPAL_INVESTIGATOR

Yogita S Patel, BSc

CONTACT

[email protected]

905-522-1155 ext. 35096

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age between 18 and 120 years at time of consent
  • Ability to speak and understand English
  • Clinical stage I, II or IIIa NSCLC
  • Candidate for RTS, as determined by the operating surgeon

Exclusion criteria

  • Anticoagulation with inability to cease anticoagulant therapy prior to surgery
  • Incurable coagulopathy
  • Systemic vascular disease or vasculitis
  • Not a candidate for RTS

Treatment and study plan

Medtronic Signia Stapler

Device

The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.

Vessel Sealer Extend Energy Device and SureForm Stapler

Device

The Vessel Sealer Extend Energy Device is integrated with the da Vinci system and uses bipolar energy technology to facilitate tissue dissection and vessel sealing.

Primary outcomes

  1. Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection

    Time frame: Up to 3 weeks following hospital discharge

    Surgical device (stapler or energy) costs per surgery, along with inpatient hospitalization costs per day following surgery will be collected and evaluated in Canadian dollars.

Secondary outcomes

  1. Operating Room Time

    Time frame: 3 weeks post-surgery

    Entry into Operating Room to Exit, in minutes

  2. Length of Stay in Hospital

    Time frame: 3 weeks post-surgery

    Admission Date to Discharge Date, in days

  3. Duration of Chest Tube

    Time frame: 3 weeks post-surgery

    Insertion Date to Discharge Date, in days

  4. Intraoperative Complications and Adverse events (AEs)

    Time frame: 3 weeks post-surgery

    Short-term clinical outcomes, as measured by intraoperative complications and postoperative AEs, will be recorded during patient follow-ups.

Study contacts

Contact information is provided by the study sponsor or research team.

Yogita S Patel, BSc

CONTACT

[email protected]

905-522-1155 ext. 35096

Sponsors and collaborators

Lead sponsor

St. Joseph's Healthcare Hamilton

Other

Registry information

Official study title

Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 4, 2024
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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