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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


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

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