search
Back to results

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

Primary Purpose

Lung Cancer, Thoracic Cancer, Lung Neoplasm

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Medtronic Signia Stapler
Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Lung Cancer

Eligibility Criteria

18 Years - 120 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare HamiltonRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Medtronic Signia Stapler

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling

Arm Description

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

Patients randomized to this arm will undergo RTS segmentectomy with the Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling.

Outcomes

Primary Outcome Measures

Feasibility and safety
No adverse impacts of the study procedures on participants
Recruitment
Recruitment rate of at least 70%
Randomization
Ability to randomize patients to one of two groups
Data collection of stapler reload model
Ability to collect the type of stapler reloads used
Data collection of stapler quantities
Ability to collect the number of stapler reloads used
Data collection of energy sealing data
Ability to collect the sealing time in seconds
Data collection of energy device data
Ability to collect the generator setting of the energy device

Secondary Outcome Measures

Adverse events (AEs) and complications
Short-term clinical outcomes, as measured by postoperative AEs and complications, will be recorded during patient follow-ups.
Intraoperative costs of stapler or energy device use
Surgical device (stapler or energy) costs per surgery will be collected and evaluated in Canadian dollars.
Hospitalization costs based on length of hospital stay
Inpatient hospitalization costs per day following surgery will be collected in Canadian dollars.

Full Information

First Posted
January 13, 2023
Last Updated
June 28, 2023
Sponsor
St. Joseph's Healthcare Hamilton
search

1. Study Identification

Unique Protocol Identification Number
NCT05727735
Brief Title
Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Recruiting
Study Start Date
April 14, 2023 (Actual)
Primary Completion Date
September 8, 2023 (Anticipated)
Study Completion Date
September 29, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

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
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Cancer, Thoracic Cancer, Lung Neoplasm

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Medtronic Signia Stapler
Arm Type
Active Comparator
Arm Description
Patients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler.
Arm Title
Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling
Arm Type
Experimental
Arm Description
Patients randomized to this arm will undergo RTS segmentectomy with the Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling.
Intervention Type
Device
Intervention Name(s)
Medtronic Signia Stapler
Intervention Description
The Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery.
Intervention Type
Drug
Intervention Name(s)
Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling
Intervention Description
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.
Primary Outcome Measure Information:
Title
Feasibility and safety
Description
No adverse impacts of the study procedures on participants
Time Frame
Up to 3 weeks post-surgery
Title
Recruitment
Description
Recruitment rate of at least 70%
Time Frame
Up to 8 weeks after recruitment first opens
Title
Randomization
Description
Ability to randomize patients to one of two groups
Time Frame
Baseline
Title
Data collection of stapler reload model
Description
Ability to collect the type of stapler reloads used
Time Frame
Up to 3 weeks post-surgery
Title
Data collection of stapler quantities
Description
Ability to collect the number of stapler reloads used
Time Frame
Up to 3 weeks post-surgery
Title
Data collection of energy sealing data
Description
Ability to collect the sealing time in seconds
Time Frame
Up to 3 weeks post-surgery
Title
Data collection of energy device data
Description
Ability to collect the generator setting of the energy device
Time Frame
Up to 3 weeks post-surgery
Secondary Outcome Measure Information:
Title
Adverse events (AEs) and complications
Description
Short-term clinical outcomes, as measured by postoperative AEs and complications, will be recorded during patient follow-ups.
Time Frame
3 weeks post-surgery
Title
Intraoperative costs of stapler or energy device use
Description
Surgical device (stapler or energy) costs per surgery will be collected and evaluated in Canadian dollars.
Time Frame
Up to 3 weeks following hospital discharge
Title
Hospitalization costs based on length of hospital stay
Description
Inpatient hospitalization costs per day following surgery will be collected in Canadian dollars.
Time Frame
From admission to discharge, up to 14 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Yogita S Patel, BSc
Phone
905-522-1155
Ext
35096
Email
patelys@mcmaster.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Waël C Hanna, MMDCM MBA FRCSC
Organizational Affiliation
St. Joseph's Healthcare Hamilton
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Yogita S Patel, BSc
Phone
905-522-1155
Ext
35096
Email
patelys@mcmaster.ca
First Name & Middle Initial & Last Name & Degree
Waël C Hanna, MDCM MBA FRCSC
First Name & Middle Initial & Last Name & Degree
Esther Provost

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs