Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06369597
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-17
First Post:
2024-04-13
Brief Title:
A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
A Randomized Controlled Trial of the Safety and Efficacy of Robotic Telesurgery Versus Laparoscopic Surgery
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
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:
This is a randomized controlled trial that will be preceded by a safety trial focusing on the safety and efficacy of robotic telesurgery The hypothesis is that robotic telesurgery has a non-inferior primary endpoint event rate to local laparoscopic surgery
Detailed Description:
First a safety run-in trial for robotic telesurgery will be conducted and evaluated according to 33 design At least 3 patients of each cancer type including liver cancerrenal cancer and rectal cancer will be enrolled for robotic telesurgery If there is a tumor type for which the prior safety trial is terminated the subsequent randomized controlled trial will not include patients of that type
Second after passing the safety run-in trial a randomized controlled trial will be performed New patients with each cancer type who met the enrollment criteria will be randomly assigned to either the laparoscopic surgery groupcontrol group or the robotic telesurgery group intervention group 84 patients in each group 168 patients in total in a 11 two-group parallel design
Second after passing the safety run-in trial a randomized controlled trial will be performed New patients with each cancer type who met the enrollment criteria will be randomly assigned to either the laparoscopic surgery groupcontrol group or the robotic telesurgery group intervention group 84 patients in each group 168 patients in total in a 11 two-group parallel design
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