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NCT06348030Not yet recruiting

Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC

Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer: A Randomized Controlled Trial
St. Joseph's Healthcare HamiltonClinicalTrials.govdeviceDevice trial
Study focus
Disease/Condition
Lung Cancer
Drug/Device/Intervention
Medtronic Signia Stapler
Study type
Interventional
Intervention type
device
Sponsor & location
Primary sponsor
St. Joseph's Healthcare Hamilton
Location
Hamilton, Canada
Timeline & enrollment
Phase
N/A
Start date
Apr 01, 2024
End date
Mar 01, 2026
Enrollment
120 participants
Primary outcome

Costs of Totally Robotic versus Surgeon-Assisted Robotic Lung Resection

Summary

Robotic-assisted thoracoscopic surgery (RTS) is safe and effective for patients with
 early-stage non-small cell lung cancer (NSCLC). During RTS, division, dissection, and sealing
 of lung tissue, bronchi, and blood vessels can be performed using handheld staplers with
 assistance from a bedside surgeon (Surgeon-Assisted), or totally robotically with robotic
 staplers and energy devices by the console surgeon (Totally Robotic). Totally Robotic lung
 resection enables the operating surgeon to perform the case independently, but its
 implication on costs and patient outcomes remains unknown. There also is, however, a lack of
 prospective research evaluating the costs of the two methods for dissection and vessel
 sealing in RTS. This RCT aims to evaluate the costs and perioperative patient outcomes of
 Totally Robotic lung resection using the Vessel Sealer Extend energy device (for vessels
 7mm) and the SureForm robotic stapler (Intervention) versus Surgeon-Assisted robotic lung
 resection using the Signia stapler (Control) during RTS for NSCLC using the da Vinci system.

ICD-10 classifications
Carcinoma in situ: Bronchus and lungSecondary malignant neoplasm of lungMalignant neoplasm of bronchus and lungMalignant neoplasm: Bronchus or lung, unspecifiedMalignant neoplasm: Overlapping lesion of bronchus and lung
Data source
Registry
ClinicalTrials.gov
Trial ID
NCT06348030
Type
Device Trial
About this record

Access comprehensive clinical trial information for NCT06348030 through Pure Global AI's free database. This phase not specified trial is sponsored by St. Joseph's Healthcare Hamilton and is currently Not yet recruiting. The study focuses on Lung Cancer. Target enrollment is 120 participants.

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