Ignite Creation Date:
2024-05-06 @ 8:16 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06319053
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2024-02-15
Brief Title:
The Turbine-based Insufflator Safety and Feasibility Study
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
The Turbine-based Insufflator a Safety and Feasibility Study During Laparoscopy
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:
TBI
Brief Summary:
The turbine-based insufflator for minimal access surgery provides a new technological basis for minimal invasive surgery insufflation Turbine technology permits highly accurate pressure control an intra-abdominal volume that is dynamically adapted to ventilation and oscillometric measurements of abdominal compliance This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device
Detailed Description:
The turbine-based insufflator for minimal access surgery provides a new technological basis for insufflation Until now insufflation uses a static pressurized gas volume that is strongly affected by external pressure and vice versa pressures onto the surrounding structures Turbine technology permits highly accurate pressure control and an intra-abdominal volume that is dynamically adapted to ventilation In this safety and feasibility trial the pressure stability of a turbine-based insufflator is investigated in patients undergoing laparoscopic surgery In addition small amplitude oscillation are superimposed to the intra-abdominal pressure at the start of insufflation Those oscillometric measurements will be used to estimate the abdominal compliance through the forced oscillation technique
Study population Adults who are scheduled for an elective intraperitoneal laparoscopic surgical procedure at Erasmus MC
Main study parameters safety and feasibility of turbine-based insufflation in terms of Serious Adverse Device Effects
Study population Adults who are scheduled for an elective intraperitoneal laparoscopic surgical procedure at Erasmus MC
Main study parameters safety and feasibility of turbine-based insufflation in terms of Serious Adverse Device Effects
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