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NCT Number: NCT06319053

The Turbine-based Insufflator Safety and Feasibility Study

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.

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Key information

Conditions

Laparoscopy Digestive System Diseases Peritoneal Diseases Pneumoperitoneum

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Erasmus MC, University Medical Center Rotterdam

Rotterdam, South Holland, 3015 GD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Turbine-based insufflator

Device

The use of a turbine-based insufflator instead of a conventional insufflator

Primary outcomes

  1. Occurrence of (serious) adverse device effects [Safety and feasibility of the device]

    Time frame: During the surgical procedure

    Recording all adverse device effects as defined in the study protocol

Secondary outcomes

  1. Observation of insufflation pressure stability by continuously monitoring and recording.

    Time frame: During the surgical procedure

    Assessment of stability of the intra-abdominal pressure generated by the device during the surgical procedure using descriptive statistics of deviation from set-pressure.

  2. Gas volume exchange

    Time frame: During the surgical procedure

    Determination of the gas volume exchange required to keep insufflation pressures stable.

  3. Estimation of the abdominal compliance

    Time frame: <6 months after the surgical procedure

    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.

  4. Intra-abdominal target pressure in relation to the abdominal compliance

    Time frame: <6 months after the surgical procedure

    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.

Sponsors and collaborators

Lead sponsor

Erasmus Medical Center

Other

Collaborators

  • Health∼Holland, Topsector Life Sciences & Health
  • IDE Group B.V.
  • Politecnico di Milano University
  • Spatium Medical B.V.

Registry information

Official study title

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

Acronym: TBI

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Mar 19, 2024
Registry last updated
Nov 5, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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