Ignite Creation Date:
2024-07-17 @ 10:49 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06480214
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-05-13
Brief Title:
Research on Key Technology Development and Clinical Application of Small Interactive Spinal Endoscopic Surgery Robot
Sponsor:
Beijing Jishuitan Hospital
Organization:
Beijing Jishuitan Hospital
Study Overview
Official Title:
Research on Key Technology Development and Clinical Application of Small Interactive Spinal Endoscopic Surgery Robot
Status:
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:
The aim of the study was to investigate the correlation between the extent of decompression and patient follow-up metrics at 1 year postoperatively by analysing data from a real-world multicentre cohort of patients and to clarify the precise extent of decompression for endoscopic spine surgery
Detailed Description:
In recent years endoscopic spine surgery has developed rapidly especially in the treatment of degenerative spinal diseases Minimally invasive endoscopic spine surgery has been widely implemented and promoted in hospitals at all levels The learning curve of endoscopic spinal surgery is steep because it is performed in a narrow space adjacent to sensitive structures such as nerves and blood vessels The surgical effect completely depends on the experience of the surgeon How to break through the bottleneck and forbidden zone of endoscopic spine surgery and establish a perfect treatment system for endoscopic spine surgery has become one of the urgent problems and challenges in current spine surgery At present enabling technologies such as artificial intelligence computer-assisted surgical navigation and robotics have been applied in spinal surgery but their functions are limited to stereotactic orientation Endoscopic spinal surgery robots that can meet the needs of intelligent surgical planning precise decompression and flexible micromanipulation under endoscope are still lacking in the world It is of great practical significance to develop an endoscopic spinal surgery robot platform with artificial intelligence characteristics and based on this establish an endoscopic spinal surgery treatment system oriented by accurate safe and effective improvement of patient clinical outcomes which is expected to improve the level of diagnosis and treatment of spinal surgery and promote the transformation and industrialization of a new generation of surgical technology The objectives of this project include 1 to conduct a real-world study on the precise decompression range of endoscopic spine surgery to investigate the artificial intelligence-assisted spinal segmentation and automatic decompression planning for endoscopic spine surgery 2 Develop a new generation of small interactive intelligent endoscopic robot system and supporting new minimally invasive surgical instruments and study the human-computer interaction control strategy suitable for narrow space 3 Carry out the effectiveness and safety research of the endoscopic spinal surgery robot and verify it in model bones animal bones and humans in general The products are approved and clinical trials are completed after the relevant parts are filed Finally a small interactive endoscopic surgery robot platform and an intelligent decompression planning system were successfully developed which clarified the scope and operation specification of accurate endoscopic decompression provided guidance for the popularization of endoscopic surgery and formed the operation process specification of small interactive minimally invasive endoscopic surgery
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