Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy

The Feasibility of Assessing Economic Costs of the Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy for Lung Cancer

Robotic-assisted thoracoscopic surgery (RTS) segmentectomy is safe and effective for patients with early-stage non-small cell lung cancer (NSCLC). In RTS-segmentectomy, dissection and sealing procedures are performed by either staplers or energy devices.

Staplers, the current standard of care, have been associated with higher operating costs compared to energy devices for open lobectomy, RTS lobectomy and minimally invasive segmentectomy. However, there is a lack of prospective research evaluating the costs of the two methods for lung dissection and vessel sealing in RTS-segmentectomy.

This prospective trial seeks to determine whether it is feasible to conduct a randomized controlled trial evaluating the costs of the Signia stapler versus Vessel Sealer Extend energy device in RTS-segmentectomy for NSCLC. If this trial is feasible, we will be able to conduct a full-scale trial to compare costs and health outcomes, providing an economic evaluation that will inform hospital decision makers and clinicians in Canada.

Study Overview

• Status: Completed
• Conditions: Lung Cancer; Thoracic Cancer; Lung Neoplasm
• Intervention / Treatment: Device: Medtronic Signia Stapler; Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Healthcare Hamilton

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 120 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 segmentectomy, 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 segmentectomy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Medtronic Signia Stapler; Patients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler.	Device: Medtronic Signia Stapler; The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
Experimental: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling; Patients randomized to this arm will undergo RTS segmentectomy with the Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling.	Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Feasibility and safety	No adverse impacts of the study procedures on participants	Up to 3 weeks post-surgery
Recruitment	Recruitment rate of at least 70%	Up to 8 weeks after recruitment first opens
Randomization	Ability to randomize patients to one of two groups	Baseline
Data collection of stapler reload model	Ability to collect the type of stapler reloads used	Up to 3 weeks post-surgery
Data collection of stapler quantities	Ability to collect the number of stapler reloads used	Up to 3 weeks post-surgery
Data collection of energy sealing data	Ability to collect the sealing time in seconds	Up to 3 weeks post-surgery
Data collection of energy device data	Ability to collect the generator setting of the energy device	Up to 3 weeks post-surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events (AEs) and complications	Short-term clinical outcomes, as measured by postoperative AEs and complications, will be recorded during patient follow-ups.	3 weeks post-surgery
Intraoperative costs of stapler or energy device use	Surgical device (stapler or energy) costs per surgery will be collected and evaluated in Canadian dollars.	Up to 3 weeks following hospital discharge
Hospitalization costs based on length of hospital stay	Inpatient hospitalization costs per day following surgery will be collected in Canadian dollars.	From admission to discharge, up to 14 days

Collaborators and Investigators

• Sponsor: St. Joseph's Healthcare Hamilton
• Investigators: Principal Investigator: Waël C Hanna, MMDCM MBA FRCSC, St. Joseph's Healthcare Hamilton

Study record dates

Study Major Dates

• Study Start (Actual): April 14, 2023
• Primary Completion (Actual): April 30, 2024
• Study Completion (Actual): April 30, 2024

Study Registration Dates

• First Submitted: January 13, 2023
• First Submitted That Met QC Criteria: February 13, 2023
• First Posted (Actual): February 14, 2023

Study Record Updates

• Last Update Posted (Actual): July 31, 2024
• Last Update Submitted That Met QC Criteria: July 29, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Neoplasms; Lung Diseases; Neoplasms by Site; Respiratory Tract Neoplasms; Thoracic Neoplasms; Lung Neoplasms
• Other Study ID Numbers: 15910

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes