The Turbine-based Insufflator Safety and Feasibility Study (TBI)

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

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.

Study Overview

• Status: Completed
• Conditions: Pneumoperitoneum; Laparoscopy
• Intervention / Treatment: Device: Turbine-based insufflator

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.

• Study Type: Interventional
• Enrollment (Actual): 12
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Zuid Holland
    • Rotterdam, Zuid Holland, Netherlands, 3015 GD
      • Erasmus MC, University Medical Center Rotterdam

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Laparoscopy; Adult study participants who are planned to undergo intraperitoneal laparoscopic surgery	Device: Turbine-based insufflator; The use of a turbine-based insufflator instead of a conventional insufflator

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
Gas volume exchange	Determination of the gas volume exchange required to keep insufflation pressures stable.	During the surgical procedure
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
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

Collaborators and Investigators

• Sponsor: Erasmus Medical Center
• Collaborators: Health∼Holland, Topsector Life Sciences & Health; Politecnico di Milano University; Spatium Medical B.V.; IDE Group B.V.
• Investigators: Principal Investigator: J. Vlot, MD, PhD, Erasmus MC, University Medical Center Rotterdam

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2024
• Primary Completion (Actual): October 1, 2024
• Study Completion (Actual): October 1, 2024

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: March 18, 2024
• First Posted (Actual): March 19, 2024

Study Record Updates

• Last Update Posted (Estimated): November 5, 2024
• Last Update Submitted That Met QC Criteria: November 2, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Pneumoperitoneum; Laparoscopy; Device development; Insufflator
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum
• Other Study ID Numbers: NL85402.078.23

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No