LaparoscopyTuBaNCT07715968
The Turbine-based CO2 Insufflator Pediatric Feasibility Study
A study testing Turbine-based insufflator in people with Laparoscopy and Pneumoperitoneum, run by Erasmus Medical Center at 1 site in Netherlands.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 18 years
- Conditions the study is for
- Laparoscopy, Pneumoperitoneum
- What is being tested?
- Turbine-based insufflator
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteNetherlands
- Study dates
- 10 Feb 2026to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Weight ≥ 10 kilograms;
- Laparoscopic procedure;
- Intraperitoneal procedure;
- Written informed consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
J. Vlot contact
Netherlands1 site, 1 recruiting
- Recruiting
Erasmus MC, University Medical Center Rotterdam
Rotterdam, South Holland, 3015 GD
J. Vlot, +31107039568, john.vlot@erasmusmc.nl
About this study
Official title: The Use of the Turbine-based CO2 Insufflator in Pediatric Laparoscopic Surgery - a Feasibility Trial
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.
Read the detailed description
A new CO2 insufflator, the turbine-based insufflator (TBI), has been developed with an insufflation technique that enables highly accurate pressure control that is dynamically adapted to ventilation. It is hypothesized that this novel insufflation technique provides more stable abdominal pressures than conventional insufflators and reduces the need for high ventilation pressures. The pediatric population can benefit greatly from this new insufflation technique, as small changes in pressure settings and stabilization of the surgical field already have a relatively large impact.
- Conditions
- Laparoscopy, Pneumoperitoneum
- Being tested
- Turbine-based insufflator
- Keywords
- Pneumoperitoneum, Device development, Insufflator, Laparoscopy
- Medical subject headings
- Pneumoperitoneum
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Turbine-based insufflatorDevice
Use of the Tubine-based insufflator during surgical procedure.
| Study group | Role | What they receive |
|---|---|---|
| Pediatric laparoscopy | Experimental | Pediatric population, planned for intraperitoneal laparoscopic surgery. Receives: Device: Turbine-based insufflator |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: During surgery
Secondary outcomes (4)
Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure
Recording the intra-abdominal pressure with a pressure line during the surgical procedure. Assessment of the difference between the actual measured pressure and the target pressure. Stability is defined as the median pressure with the interquartile range.
Measured: During surgery
Registration of events that impair intra-abdominal pressure stability (observationa, qualitative)
Measured: 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.
Between turbine-based insufflation and conventional insufflation.
Measured: During surgery
Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculating the abdominal compliance; quantitative measurements)
Intra-abdominal pressure and intra-abdominal flow data recording during surgical procedure.
Measured: During surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2026
- Study start10 Feb 2026
- Primary completion1 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LaparoscopyStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 12 children for whom informed consent will be obtained from their parents and from the child.
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Politecnico di Milano University, Health∼Holland, Topsector Life Sciences & Health, Spatium Medical B.V.
- Responsible party
- Principal investigator, Ass. Prof. J (John) Vlot MD, PhD, FEBPS, Erasmus Medical Center
- Investigators
- J. Vlot, Principal investigator, Erasmus Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07715968
- Sponsor's protocol ID
- NL-010054
- Acronym
- TuBa
- Status last verified
- Sep 2026
- First submitted
- 27 Jan 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of the Turbine-based CO2 Insufflator in Pediatric Laparoscopic Surgery - a Feasibility Trial
- ClinicalTrials.gov ID
- NCT07715968
- Acronym / sponsor ID
- TuBa / NL-010054
- Conditions
- Laparoscopy, Pneumoperitoneum
- Keywords
- Pneumoperitoneum, Device development, Insufflator, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Politecnico di Milano University, Health∼Holland, Topsector Life Sciences & Health, Spatium Medical B.V.
- Study start
- 10 Feb 2026 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 21 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
A new CO2 insufflator, the turbine-based insufflator (TBI), has been developed with an insufflation technique that enables highly accurate pressure control that is dynamically adapted to ventilation. It is hypothesized that this novel insufflation technique provides more stable abdominal pressures than conventional insufflators and reduces the need for high ventilation pressures. The pediatric population can benefit greatly from this new insufflation technique, as small changes in pressure settings and stabilization of the surgical field already have a relatively large impact.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 12 children for whom informed consent will be obtained from their parents and from the child.
| Arm | Type | Receives |
|---|---|---|
| Pediatric laparoscopy | Experimental | Device: Turbine-based insufflatorPediatric population, planned for intraperitoneal laparoscopic surgery. |
Who may qualify
- Ages
- Up to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Weight ≥ 10 kilograms;
- Laparoscopic procedure;
- Intraperitoneal procedure;
- Written informed consent.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Turbine-based insufflatorUse of the Tubine-based insufflator during surgical procedure. | Device | Pediatric laparoscopy |
Primary outcome
The number of adverse device events as assessed by observations during the procedure (qualitative measurements)
Time frame: During surgery
Observations of researcher and surgeon (number of adverse device events)
4 secondary outcomes
Assessment of intra-abdominal pressure stability, assessed by the median and interquartile range of the actual measured pressure
Time frame: During surgery
Registration of events that impair intra-abdominal pressure stability (observationa, qualitative)
Time frame: 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.
Time frame: During surgery
Abdominal compliance by performing endoscopic oscillometry in a pediatric population (using insufflation pressure and flow for calculating the abdominal compliance; quantitative measurements)
Time frame: During surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
J. Vlot contact
J. Vlot principal investigator
Erasmus Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Turbine-based insufflator in people with Laparoscopy and Pneumoperitoneum, run by Erasmus Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 11 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact A.I. Jong (+31107037641, a.i.dejong@erasmusmc.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of adverse device events as assessed by observations during the procedure (qualitative measurements) (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2026.