Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05486299
Status:
UNKNOWN
Last Update Posted:
2022-08-05
First Post:
2022-08-01
Brief Title:
Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery
Sponsor:
Ruijin Hospital
Organization:
Ruijin Hospital
Study Overview
Official Title:
Clinical Study of the Safety of a Single-port Endoscopic Surgical System for General Surgery An Exploratory Study of a Novel Robotic System
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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 small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery
Detailed Description:
Single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision It has the advantages of less surgical trauma better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery However the technical challenges and difficulties including loss of triangulation parallel coaxial effect difficulty of achieving correct exposure shared fulcrum lack of ergonomic favorable position etc limited its widespread use Robot-assisted laparoscopic surgery have significant advantages such as minimally invasive delicate and flexible which can greatly expand the surgeons surgical capabilities and effectively solve the various problems faced by traditional surgery Therefore robotic assisted single-port surgery is attracting increasing attention This study is to investigate the safety of a novel single-port robotic system for general 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