Lung CancerNCT05727735
Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy
A study testing Medtronic Signia Stapler and Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling in people with Lung Cancer and Thoracic Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 120 years
- Conditions the study is for
- Lung Cancer, Thoracic Cancer, Lung Neoplasm
- What is being tested?
- Medtronic Signia Stapler and Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteCanada
- Study dates
- 14 Apr 2023to 30 Apr 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Anticoagulation with inability to cease anticoagulant therapy prior to surgery
- Incurable coagulopathy
- Systemic vascular disease or vasculitis
- Not a candidate for RTS segmentectomy
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Medtronic Signia Stapler, Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Medtronic Signia StaplerDevice
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 StaplingDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Medtronic Signia Stapler | Active comparator | Patients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler. Receives: 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. Receives: Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility and safety
No adverse impacts of the study procedures on participants
Measured: Up to 3 weeks post-surgery
Recruitment
Recruitment rate of at least 70%
Measured: Up to 8 weeks after recruitment first opens
Randomization
Ability to randomize patients to one of two groups
Measured: Baseline
Data collection of stapler reload model
Ability to collect the type of stapler reloads used
Measured: Up to 3 weeks post-surgery
Data collection of stapler quantities
Ability to collect the number of stapler reloads used
Measured: Up to 3 weeks post-surgery
Data collection of energy sealing data
Ability to collect the sealing time in seconds
Measured: Up to 3 weeks post-surgery
Data collection of energy device data
Ability to collect the generator setting of the energy device
Measured: Up to 3 weeks post-surgery
Secondary outcomes (3)
Adverse events (AEs) and complications
Short-term clinical outcomes, as measured by postoperative AEs and complications, will be recorded during patient follow-ups.
Measured: 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.
Measured: 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.
Measured: From admission to discharge, up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start14 Apr 2023
- Primary completion30 Apr 2024
- Study completion30 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lung CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wael Hanna, St. Joseph's Healthcare Hamilton
- Investigators
- Waël C Hanna, MMDCM MBA FRCSC, Principal investigator, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727735
- Sponsor's protocol ID
- 15910
- Status last verified
- Jul 2024
- First submitted
- 13 Jan 2023
- Last updated
- 31 Jul 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05727735
- Acronym / sponsor ID
- 15910
- Conditions
- Lung Cancer, Thoracic Cancer, Lung Neoplasm
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- 14 Apr 2023 (actual)
- Primary completion
- 30 Apr 2024 (actual)
- Study completion
- 30 Apr 2024 (actual)
- First posted
- 14 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Medtronic Signia Stapler | Active comparator | Device: Medtronic Signia StaplerPatients randomized to this arm will undergo RTS segmentectomy with the Medtronic Signia Stapler. |
| Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling | Experimental | Drug: Da Vinci Vessel Sealer Extend Energy Device with SureForm StaplingPatients randomized to this arm will undergo RTS segmentectomy with the Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling. |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (4 listed)
- Anticoagulation with inability to cease anticoagulant therapy prior to surgery
- Incurable coagulopathy
- Systemic vascular disease or vasculitis
- Not a candidate for RTS segmentectomy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Medtronic Signia StaplerThe Signia Stapler is a powered stapler that can be used for tissue dissection and vessel sealing during surgery. | Device | Medtronic Signia Stapler |
| Da Vinci Vessel Sealer Extend Energy Device with SureForm StaplingThe Vessel Sealer Extend Energy Device is integrated with the da Vinci system and uses bipolar energy technology to facilitate tissue dissection and vessel sealing. | Drug | Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling |
Primary outcome
Feasibility and safety
Time frame: Up to 3 weeks post-surgery
No adverse impacts of the study procedures on participants
Recruitment
Time frame: Up to 8 weeks after recruitment first opens
Recruitment rate of at least 70%
Randomization
Time frame: Baseline
Ability to randomize patients to one of two groups
Data collection of stapler reload model
Time frame: Up to 3 weeks post-surgery
Ability to collect the type of stapler reloads used
Data collection of stapler quantities
Time frame: Up to 3 weeks post-surgery
Ability to collect the number of stapler reloads used
Data collection of energy sealing data
Time frame: Up to 3 weeks post-surgery
Ability to collect the sealing time in seconds
Data collection of energy device data
Time frame: Up to 3 weeks post-surgery
Ability to collect the generator setting of the energy device
3 secondary outcomes
Adverse events (AEs) and complications
Time frame: 3 weeks post-surgery
Intraoperative costs of stapler or energy device use
Time frame: Up to 3 weeks following hospital discharge
Hospitalization costs based on length of hospital stay
Time frame: From admission to discharge, up to 14 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Waël C Hanna, MMDCM MBA FRCSC principal investigator
St. Joseph's Healthcare Hamilton
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Medtronic Signia Stapler and Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling in people with Lung Cancer and Thoracic Cancer, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility and safety (time frame: Up to 3 weeks post-surgery). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2024.