The Turbine-based CO2 Insufflator Pediatric Feasibility Study

NCT07715968 | Recruiting DMC

• 1 other identifier: NL-010054
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pneumoperitoneum; Device development; Insufflator; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• The number of adverse device events as assessed by observations during the procedure (qualitative measurements)

  Observations of researcher and surgeon (number of adverse device events)

  During surgery

Secondary Outcomes (4)

• Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure

  During surgery

• Registration of events that impair intra-abdominal pressure stability (observationa, qualitative)

  During surgery

• Comparison of intra-abdominal pressure stability and ventilation pressures between conventional insufflation and turbine-based insufflation by comparing median, minimum, and maximum pressures.

  During surgery

• Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculaing the abodminal compliance; quantitative measurements)

  During surgery

Study Arms (1)

Pediatric laparoscopy

EXPERIMENTAL

Pediatric population, planned for intraperitoneal laparoscopic surgery.

Device: Turbine-based insufflator

Interventions

Turbine-based insufflator DEVICE

Use of the tubine-based insufflator during surgical procedure.

Pediatric laparoscopy

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Weight ≥ 10 kilograms (kg);
• Laparoscopic procedure;
• Intraperitoneal procedure;
• Written informed consent.

You may not qualify if:

• Inability to use the study-specific trocar during the procedure (surgeon's assessment);
• The expected time for abdominal insufflation is less than 20 minutes;
• Conversion to open surgery within 10 minutes after study measurements;
• Pregnancy.

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Politecnico di Milano University: collaborator
• Health∼Holland, Topsector Life Sciences & Health: collaborator
• Spatium Medical B.V.: collaborator

Study Sites (1)

Erasmus MC, University Medical Center Rotterdam

Rotterdam, South Holland, 3015 GD, Netherlands

RECRUITING

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• J. Vlot

  Erasmus Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

A.I. Jong

CONTACT

+31107037641; a.i.dejong@erasmusmc.nl

J. Vlot

CONTACT

+31107039568

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant pediatric surgeon

Model Details: 12 children for whom informed consent can be obtained from their parents and/or from the child.

Study Record Dates

• First Submitted: January 27, 2026
• First Posted: July 21, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: July 21, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)