The Turbine-based Insufflator Safety and Feasibility Study

Laparoscopy Clinical Trial

— TBI  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06319053
• Other study ID #: NL85402.078.23
• Status: Recruiting
• Phase: N/A
• Start date: March 4, 2024
• Est. completion date: October 2024

Study information

• Verified date: April 2024
• Source: Erasmus Medical Center
• Contact: J. Vlot, MD, PhD
• Phone: +31107039568
• Email: john.vlot[@]erasmusmc.nl
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 12
• Est. completion date: October 2024
• Est. primary completion date: September 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adult
• Elective laparoscopic surgery
• Intraperitoneal procedure
• Planned use of a main 12 mm trocar
• Informed consent

Exclusion Criteria:

• Pregnancy
• Inability to contain the insufflation gas to the intraperitoneal cavity

Related Conditions & MeSH terms

• Laparoscopy
• Pneumoperitoneum

Intervention

Device:
• Turbine-based insufflator
The use of a turbine-based insufflator instead of a conventional insufflator

Locations

Country	Name	City	State
Netherlands	Erasmus MC, University Medical Center Rotterdam	Rotterdam	Zuid Holland

Sponsors (5)

Lead Sponsor	Collaborator
Erasmus Medical Center	Health~Holland, Topsector Life Sciences & Health, IDE Group B.V., Politecnico di Milano University, Spatium Medical B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of (serious) adverse device effects [Safety and feasibility of the device]	Recording all adverse device effects as defined in the study protocol	During the surgical procedure
Secondary	Observation of insufflation pressure stability by continuously monitoring and recording.	Assessment of stability of the intra-abdominal pressure generated by the device during the surgical procedure using descriptive statistics of deviation from set-pressure.	During the surgical procedure
Secondary	Gas volume exchange	Determination of the gas volume exchange required to keep insufflation pressures stable.	During the surgical procedure
Secondary	Estimation of the abdominal compliance	During the surgical procedure, oscillometry is performed with different frequencies and different pressures. Based on the acquired data the abdominal cavity's compliance will be determined by calculating the Impedance.	<6 months after the surgical procedure
Secondary	Intra-abdominal target pressure in relation to the abdominal compliance	The target intra-abdominal pressure for the procedure as determined by the surgeon will be plotted on the compliance curve that is measured with oscillometry. Ultimately we aim to determine biomechanical optimum pressure based on oscillometry data.	<6 months after the surgical procedure