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Energy Device

Stapler vs. Energy Device for Early-Stage Lung Cancer

N/A

Recruiting

Led By Waël C Hanna, MMDCM MBA FRCSC

Research Sponsored by St. Joseph's Healthcare Hamilton

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age between 18 and 120 years at time of consent

Clinical stage I, II or IIIa NSCLC

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from admission to discharge, up to 14 days

Awards & highlights

Study Summary

This trial aims to compare costs and health outcomes of stapler vs. energy device for lung segmentectomy in early-stage lung cancer patients.

Who is the study for?

This trial is for adults aged 18-120 with early-stage non-small cell lung cancer (NSCLC) who are candidates for robotic-assisted thoracoscopic surgery (RTS) segmentectomy. Participants must speak and understand English. Those with uncontrollable bleeding disorders, on anticoagulants that can't be stopped before surgery, or have systemic vascular diseases are excluded.Check my eligibility

What is being tested?

The study compares two methods used in RTS-segmentectomy: the Medtronic Signia Stapler and the Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling. It aims to determine if a larger trial comparing costs and health outcomes of these devices is feasible.See study design

What are the potential side effects?

While specific side effects aren't listed, both staplers and energy devices may cause complications like bleeding, infection at the surgical site, pain or discomfort post-surgery, and potential damage to surrounding tissues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am at least 18 years old.

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My lung cancer is at an early to mid-stage.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Data collection of energy device data

Data collection of energy sealing data

Data collection of stapler quantities

+4 more

Secondary outcome measures

Adverse events (AEs) and complications

Hospitalization costs based on length of hospital stay

Intraoperative costs of stapler or energy device use

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Da Vinci Vessel Sealer Extend Energy Device with SureForm StaplingExperimental Treatment1 Intervention

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

Group II: Medtronic Signia StaplerActive Control1 Intervention

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

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonLead Sponsor

196 Previous Clinical Trials

25,494 Total Patients Enrolled

Waël C Hanna, MMDCM MBA FRCSCPrincipal InvestigatorSt. Joseph's Healthcare Hamilton

Media Library

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling (Energy Device) Clinical Trial Eligibility Overview. Trial Name: NCT05727735 — N/A

Lung Cancer Research Study Groups: Medtronic Signia Stapler, Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling

Lung Cancer Clinical Trial 2023: Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling Highlights & Side Effects. Trial Name: NCT05727735 — N/A

Da Vinci Vessel Sealer Extend Energy Device with SureForm Stapling (Energy Device) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05727735 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is there an upper age limit for enrolment into this clinical trial?

"The enrollment criteria for this medical trial state that the minimum age requirement is 18 and participants must not exceed 120 years old."

Answered by AI

Is there still capacity to join this clinical study?

"The clinical trial, posted on February 23rd 2023 and last edited two weeks later, is not actively accepting applicants. However, 1616 other studies are recruiting patients at this moment in time."

Answered by AI

What criteria must be met for an individual to take part in this trial?

"This lung cancer trial has 50 available slots for those aged between 18 and 120. In order to take part, applicants must possess the capability of speaking and understanding English, diagnosed with clinical stages I, II or IIIa NSCLC, and be suitable candidates for RTS segmentectomy as determined by their surgeon."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

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

Wael Hanna 2023. "Signia Stapler Versus Vessel Sealer Extend Energy Device With SureForm Stapling in Robotic-Assisted Segmentectomy". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05727735.