NCT07715968 The Turbine-based CO2 Insufflator Pediatric Feasibility Study
| NCT ID | NCT07715968 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Erasmus Medical Center |
| Condition | Laparoscopy |
| Study Type | INTERVENTIONAL |
| Enrollment | 12 participants |
| Start Date | 2026-02-10 |
| Primary Completion | 2026-12-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 12 participants in total. It began in 2026-02-10 with a primary completion date of 2026-12-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
A novel CO2 insufflator, the Turbine-based insufflator, has been developed to improve minimally 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 the Turbine-based insufflator, and comparison of ventiliation pressures between these insufflators.
Eligibility Criteria
Inclusion Criteria: * Weight ≥ 10 kilograms; * Laparoscopic procedure; * Intraperitoneal procedure; * Written informed consent. Exclusion Criteria: * 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.
Contact & Investigator
J. Vlot
PRINCIPAL INVESTIGATOR
Erasmus Medical Center
Frequently Asked Questions
Who can join the NCT07715968 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Laparoscopy. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07715968 currently recruiting?
Yes, NCT07715968 is actively recruiting participants. Contact the research team at a.i.dejong@erasmusmc.nl for enrollment information.
Where is the NCT07715968 trial being conducted?
This trial is being conducted at Rotterdam, Netherlands.
Who is sponsoring the NCT07715968 clinical trial?
NCT07715968 is sponsored by Erasmus Medical Center. The principal investigator is J. Vlot at Erasmus Medical Center. The trial plans to enroll 12 participants.