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The Turbine-based CO2 Insufflator Pediatric Feasibility Study

NCT07715968 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2026-07-21

No results posted yet for this study

Summary

A novel CO2 insufflator, the turbine-based insufflator, has been developed to improve minimal invasive surgery. Turbine technology permits accurate pressure control resulting in an intra-abdominal volume that is dynamically adapted to ventilation. In addition, oscillometric measurements are performed to measure the abdominal compliance of the patient. This feasibility trial primarly aims to evaluate the technologic feasibility during pediatric laparoscopic surgery. Secondary outcomes are pressure stability, comparison of intra-abdominal pressure stability between the standard CO2 insufflator and turbine-based insufflator, and comparison of ventiliation pressures between these insufflators.

Conditions

  • Laparoscopy
  • Pneumoperitoneum

Interventions

DEVICE

Turbine-based insufflator

Use of the tubine-based insufflator during surgical procedure.

Sponsors & Collaborators

  • Politecnico di Milano University

    collaborator UNKNOWN

  • Health∼Holland, Topsector Life Sciences & Health

    collaborator UNKNOWN

  • Spatium Medical B.V.

    collaborator UNKNOWN

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • J. Vlot · Erasmus Medical Center

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-02-10
Primary Completion
2026-12-01
Completion
2026-12-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07715968 on ClinicalTrials.gov