Clinical trial NCT06319053: The Turbine-based Insufflator Safety and Feasibility Study
Official title: The Turbine-based Insufflator: a Safety and Feasibility Study During Laparoscopy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Laparoscopy
Pneumoperitoneum
Keywords: Pneumoperitoneum
Device development
Insufflator
Laparoscopy
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Politecnico di Milano University
name: Health∼Holland, Topsector Life Sciences & Health
name: Spatium Medical B.V.
name: IDE Group B.V.
First posted: 2024-03-19
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SEQUENTIAL
Intervention model description: Consecutive patients from who informed consent can be acquired. The number of twelve participants was determined in conjunction with the Ethical Board of Erasmus MC
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: Inclusion Criteria:

* Adult
* Elective laparoscopic surgery
* Intraperitoneal procedure
* Planned use of a main 11 mm trocar
* Informed consent

Exclusion Criteria:

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

Primary outcomes:
measure: Occurrence of (serious) adverse device effects [Safety and feasibility of the device]
timeFrame: During the surgical procedure
Secondary outcomes:
measure: Observation of insufflation pressure stability by continuously monitoring and recording.
timeFrame: During the surgical procedure
measure: Gas volume exchange
timeFrame: During the surgical procedure
measure: Estimation of the abdominal compliance
timeFrame: <6 months after the surgical procedure
measure: Intra-abdominal target pressure in relation to the abdominal compliance
timeFrame: <6 months after the surgical procedure
Other outcomes:
Locations:
city: Rotterdam
country: Netherlands
facility: Erasmus MC, University Medical Center Rotterdam
state: Zuid Holland
Study officials:
affiliation: Erasmus MC, University Medical Center Rotterdam
name: J. Vlot, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: