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

NCT ID: NCT05727735

Last Updated: 2024-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 56 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-04-14
• Study Completion Date: 2024-04-30

Brief 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.

Conditions

Lung Cancer; Thoracic Cancer; Lung Neoplasm

Study Design

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

Study Groups

Medtronic Signia Stapler

Patients randomized to this arm will undergo RTS segmentectomy 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.

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.

Group Type: EXPERIMENTAL

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling

Intervention Type: DRUG

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

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.

Intervention Type: DRUG

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 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

• 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, MMDCM MBA FRCSC

Role: PRINCIPAL_INVESTIGATOR

St. Joseph's Healthcare Hamilton

Locations

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, Canada

Countries

Canada

Other Identifiers

15910

Identifier Type: -

Identifier Source: org_study_id