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The Turbine-based Insufflator Safety and Feasibility Study — TBI  

Laparoscopy Clinical Trial

Official title:
The Turbine-based Insufflator: a Safety and Feasibility Study During Laparoscopy.

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06319053
Study type Interventional
Source Erasmus Medical Center
Contact J. Vlot, MD, PhD
Phone +31107039568
Email john.vlot@erasmusmc.nl
Status Recruiting
Phase N/A
Start date March 4, 2024
Completion date October 2024
View Details
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