Lung CancerNCT06348030
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC
A study testing Medtronic Signia Stapler and Vessel Sealer Extend Energy Device and SureForm Stapler in people with Lung Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Medtronic Signia Stapler and Vessel Sealer Extend Energy Device and SureForm Stapler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2026to Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anticoagulation with inability to cease anticoagulant therapy prior to surgery
- Incurable coagulopathy
- Systemic vascular disease or vasculitis
- Not a candidate for RTS
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, L8N 4A6
Yogita S Patel, BSc, 905-522-1155 ext. 35096, patelys@mcmaster.ca
Waël C Hanna, MDCM, MBA, FRCSC
About this study
Official title: Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial
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
- Being tested
- Medtronic Signia Stapler, Vessel Sealer Extend Energy Device and SureForm Stapler
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Signia StaplerDevice
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 StaplerDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Surgeon-Assisted | Active comparator | Patients randomized to this arm will undergo RTS with the Medtronic Signia Stapler. Receives: Device: Medtronic Signia Stapler |
| Totally Robotic | Experimental | Patients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler. Receives: Device: Vessel Sealer Extend Energy Device and SureForm Stapler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection
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.
Measured: Up to 3 weeks following hospital discharge
Secondary outcomes (4)
Operating Room Time
Entry into Operating Room to Exit, in minutes
Measured: 3 weeks post-surgery
Length of Stay in Hospital
Admission Date to Discharge Date, in days
Measured: 3 weeks post-surgery
Duration of Chest Tube
Insertion Date to Discharge Date, in days
Measured: 3 weeks post-surgery
Intraoperative Complications and Adverse events (AEs)
Short-term clinical outcomes, as measured by intraoperative complications and postoperative AEs, will be recorded during patient follow-ups.
Measured: 3 weeks post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study startSep 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionApr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Hanna, St. Joseph's Healthcare Hamilton
- Investigators
- Waël C Hanna, MDCM, MBA, FRCSC, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06348030
- Sponsor's protocol ID
- 17401
- Status last verified
- Jan 2026
- First submitted
- 28 Mar 2024
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06348030
- Acronym / sponsor ID
- 17401
- Conditions
- Lung Cancer
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Sep 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Apr 2028 (estimated)
- First posted
- 4 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgeon-Assisted | Active comparator | Device: Medtronic Signia StaplerPatients randomized to this arm will undergo RTS with the Medtronic Signia Stapler. |
| Totally Robotic | Experimental | Device: Vessel Sealer Extend Energy Device and SureForm StaplerPatients randomized to this arm will undergo RTS with the Da Vinci Vessel Sealer Extend Energy Device and SureForm Stapler. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Anticoagulation with inability to cease anticoagulant therapy prior to surgery
- Incurable coagulopathy
- Systemic vascular disease or vasculitis
- Not a candidate for RTS
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Signia StaplerThe Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery. | Device | Surgeon-Assisted |
| Vessel Sealer Extend Energy Device and SureForm StaplerThe Vessel Sealer Extend Energy Device is integrated with the da Vinci system and uses bipolar energy technology to facilitate tissue dissection and vessel sealing. | Device | Totally Robotic |
Primary outcome
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.
4 secondary outcomes
Operating Room Time
Time frame: 3 weeks post-surgery
Length of Stay in Hospital
Time frame: 3 weeks post-surgery
Duration of Chest Tube
Time frame: 3 weeks post-surgery
Intraoperative Complications and Adverse events (AEs)
Time frame: 3 weeks post-surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Waël C Hanna, MDCM, MBA, FRCSC principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Signia Stapler and Vessel Sealer Extend Energy Device and SureForm Stapler in people with Lung Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yogita S Patel, BSc (905-522-1155 ext. 35096, patelys@mcmaster.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection (time frame: Up to 3 weeks following hospital discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.