NCT06319053

The Turbine-based Insufflator Safety and Feasibility Study

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (actual)
• Sponsor: Erasmus Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Laparoscopy
• Pneumoperitoneum

Interventions

Type	Name	Description
DEVICE	Turbine-based insufflator	The use of a turbine-based insufflator instead of a conventional insufflator

Timeline

• Start date: 2024-04-03
• Primary completion: 2024-10-01
• Completion: 2024-10-01
• First posted: 2024-03-19
• Last updated: 2024-11-05

Locations

1 site across 1 country: Netherlands