Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06348030
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-08
First Post:
2024-03-28
Brief Title:
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage NSCLC
Sponsor:
St Josephs Healthcare Hamilton
Organization:
St Josephs Healthcare Hamilton
Study Overview
Official Title:
Totally Robotic Versus Surgeon-Assisted Robotic Lung Resection For Early-Stage Non-Small Cell Lung Cancer A Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None