LaparoscopyTBINCT06319053
The Turbine-based Insufflator Safety and 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
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- 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
- 3 Apr 2024to 1 Oct 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult
- Elective laparoscopic surgery
- Intraperitoneal procedure
- Planned use of a main 11 mm trocar
- Informed consent
Who cannot join
- Pregnancy
- Inability to contain the insufflation gas to the intraperitoneal cavity
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Erasmus MC, University Medical Center Rotterdam
Rotterdam, South Holland, 3015 GD
About this study
Official title: The Turbine-based Insufflator: a Safety and Feasibility Study During Laparoscopy.
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.
Read the detailed description
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.
- 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
The use of a turbine-based insufflator instead of a conventional insufflator
| Study group | Role | What they receive |
|---|---|---|
| Laparoscopy | Experimental | Adult study participants who are planned to undergo 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.
Occurrence of (serious) adverse device effects [Safety and feasibility of the device]
Recording all adverse device effects as defined in the study protocol
Measured: During the surgical procedure
Secondary outcomes (4)
Observation of insufflation pressure stability by continuously monitoring and recording.
Assessment of stability of the intra-abdominal pressure generated by the device during the surgical procedure using descriptive statistics of deviation from set-pressure.
Measured: During the surgical procedure
Gas volume exchange
Determination of the gas volume exchange required to keep insufflation pressures stable.
Measured: During the surgical procedure
Estimation of the abdominal compliance
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.
Measured: <6 months after the surgical procedure
Intra-abdominal target pressure in relation to the abdominal compliance
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.
Measured: <6 months after the surgical procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start3 Apr 2024
- Primary completion1 Oct 2024
- Study completion1 Oct 2024
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
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Model description
- Consecutive patients from who informed consent can be acquired. The number of twelve participants was determined in conjunction with the Ethical Board of Erasmus MC
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
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., IDE Group B.V.
- Responsible party
- Principal investigator, Ass. Prof. J (John) Vlot MD, PhD, FEBPS, Erasmus Medical Center
- Investigators
- J. Vlot, MD, PhD, Principal investigator, Erasmus MC, University Medical Center Rotterdam
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06319053
- Sponsor's protocol ID
- NL85402.078.23
- Acronym
- TBI
- Status last verified
- Nov 2024
- First submitted
- 15 Feb 2024
- Last updated
- 5 Nov 2024
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Turbine-based Insufflator: a Safety and Feasibility Study During Laparoscopy.
- ClinicalTrials.gov ID
- NCT06319053
- Acronym / sponsor ID
- TBI / NL85402.078.23
- Conditions
- Laparoscopy, Pneumoperitoneum
- Keywords
- Pneumoperitoneum, Device development, Insufflator, Laparoscopy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Collaborators
- Politecnico di Milano University, Health∼Holland, Topsector Life Sciences & Health, Spatium Medical B.V., IDE Group B.V.
- Study start
- 3 Apr 2024 (actual)
- Primary completion
- 1 Oct 2024 (actual)
- Study completion
- 1 Oct 2024 (actual)
- First posted
- 19 Mar 2024 (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.
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.
Detailed description
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Consecutive patients from who informed consent can be acquired. The number of twelve participants was determined in conjunction with the Ethical Board of Erasmus MC
| Arm | Type | Receives |
|---|---|---|
| Laparoscopy | Experimental | Device: Turbine-based insufflatorAdult study participants who are planned to undergo intraperitoneal laparoscopic surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult
- Elective laparoscopic surgery
- Intraperitoneal procedure
- Planned use of a main 11 mm trocar
- Informed consent
Key exclusion criteria (2 listed)
- Pregnancy
- Inability to contain the insufflation gas to the intraperitoneal cavity
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 insufflatorThe use of a turbine-based insufflator instead of a conventional insufflator | Device | Laparoscopy |
Primary outcome
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
4 secondary outcomes
Observation of insufflation pressure stability by continuously monitoring and recording.
Time frame: During the surgical procedure
Gas volume exchange
Time frame: During the surgical procedure
Estimation of the abdominal compliance
Time frame: <6 months after the surgical procedure
Intra-abdominal target pressure in relation to the abdominal compliance
Time frame: <6 months after the surgical procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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. This study is not recruiting at the moment.
J. Vlot, MD, PhD principal investigator
Erasmus MC, University Medical Center Rotterdam
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 5 inclusion and 2 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: finished, as of the sponsor's last update on 5 Nov 2024. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of (serious) adverse device effects [Safety and feasibility of the device] (time frame: During the surgical procedure). 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 5 Nov 2024; AzTrials last refreshed its copy on 30 Oct 2026.