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

NCT ID: NCT06348030

Last Updated: 2026-02-02

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-09-30
• Study Completion Date: 2028-04-30

Brief Summary

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.

Conditions

Lung Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Surgeon-Assisted

Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler.

Group Type: ACTIVE_COMPARATOR

Medtronic Signia Stapler

Intervention Type: DEVICE

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

Totally Robotic

Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler.

Group Type: EXPERIMENTAL

Vessel Sealer Extend Energy Device and SureForm Stapler

Intervention Type: 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.

Interventions

Medtronic Signia Stapler

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

Intervention Type: DEVICE

Vessel Sealer Extend Energy Device and SureForm Stapler

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.

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: lead

Responsible Party

Wael Hanna

Division Head & Associate Professor, Division of Thoracic Surgery, McMaster University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Waël C Hanna, MDCM, MBA, FRCSC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare Hamilton

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Central Contacts

Yogita S Patel, BSc

Role: CONTACT

patelys@mcmaster.ca

905-522-1155 ext. 35096

Facility Contacts

Yogita S Patel, BSc

Role: primary

patelys@mcmaster.ca

905-522-1155 ext. 35096

Other Identifiers

17401

Identifier Type: -

Identifier Source: org_study_id