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

Lung Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05727735
• Other study ID #: 15910
• Status: Recruiting
• Phase: N/A
• Start date: April 14, 2023
• Est. completion date: April 30, 2024

Study information

• Verified date: March 2024
• Source: St. Joseph's Healthcare Hamilton
• Contact: Yogita S Patel, BSc
• Phone: 905-522-1155
• Email: patelys[@]mcmaster.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: April 30, 2024
• Est. primary completion date: April 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Lung Neoplasm
• Lung Neoplasms
• Thoracic Cancer

Intervention

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

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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

Outcome

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