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

NCT05727735 | Completed DMC

• 1 other identifier: 15910
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (3)

• Adverse events (AEs) and complications

  3 weeks post-surgery

• Intraoperative costs of stapler or energy device use

  Up to 3 weeks following hospital discharge

• Hospitalization costs based on length of hospital stay

  From admission to discharge, up to 14 days

Study Arms (2)

Medtronic Signia Stapler

ACTIVE COMPARATOR

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

Device: Medtronic Signia Stapler

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling

EXPERIMENTAL

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

Interventions

Medtronic Signia Stapler DEVICE

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

Medtronic Signia Stapler

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling 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.

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Anticoagulation with inability to cease anticoagulant therapy prior to surgery
• Incurable coagulopathy
• Systemic vascular disease or vasculitis
• Not a candidate for RTS segmentectomy

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

MeSH Terms

Conditions

Lung Neoplasms

Condition Hierarchy (Ancestors)

Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Waël C Hanna, MMDCM MBA FRCSC

  St. Joseph's Healthcare Hamilton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Head & Associate Professor, Division of Thoracic Surgery, McMaster University

Study Record Dates

• First Submitted: January 13, 2023
• First Posted: February 14, 2023
• Study Start: April 14, 2023
• Primary Completion: April 30, 2024
• Study Completion: April 30, 2024
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)