Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06319053
Other study ID # NL85402.078.23
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date March 4, 2024
Est. completion date October 2024

Study information

Verified date April 2024
Source Erasmus Medical Center
Contact J. Vlot, MD, PhD
Phone +31107039568
Email john.vlot@erasmusmc.nl
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 compliance. This first-in-human study aims to evaluate technologic feasibility in terms of pressure stability performance and the safety of the device.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 12
Est. completion date October 2024
Est. primary completion date September 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Adult - Elective laparoscopic surgery - Intraperitoneal procedure - Planned use of a main 12 mm trocar - Informed consent Exclusion Criteria: - Pregnancy - Inability to contain the insufflation gas to the intraperitoneal cavity

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Turbine-based insufflator
The use of a turbine-based insufflator instead of a conventional insufflator

Locations

Country Name City State
Netherlands Erasmus MC, University Medical Center Rotterdam Rotterdam Zuid Holland

Sponsors (5)

Lead Sponsor Collaborator
Erasmus Medical Center Health~Holland, Topsector Life Sciences & Health, IDE Group B.V., Politecnico di Milano University, Spatium Medical B.V.

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary Occurrence of (serious) adverse device effects [Safety and feasibility of the device] Recording all adverse device effects as defined in the study protocol During the surgical procedure
Secondary 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. During the surgical procedure
Secondary Gas volume exchange Determination of the gas volume exchange required to keep insufflation pressures stable. During the surgical procedure
Secondary 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. <6 months after the surgical procedure
Secondary 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. <6 months after the surgical procedure
See also
  Status Clinical Trial Phase
Not yet recruiting NCT04515485 - A Volumetric Nomogram for Height, Weight, and Intra Abdominal Volume
Completed NCT01725477 - Laparoscopic Tubal Patency Assessment N/A
Recruiting NCT01093430 - Is the Anterior Superior Iliac Spine a Useful Landmark at Laparoscopy? N/A
Recruiting NCT01093079 - Laparoscopic Versus Open Partial Nephrectomy - Surgical and Oncological Outcomes N/A
Completed NCT01092013 - Comparative Evaluation of Simulator Based and Traditional In-surgery Laparoscopic Camera Training's Efficiency in Novices N/A
Completed NCT00535990 - Minimally Invasive Surgery (MIS) Database for the Purpose of Research
Recruiting NCT06044909 - Multimodal Image Registration for Helping Laparoscopic Liver Surgery Guidance
Not yet recruiting NCT05389241 - Laparoscopic Augmented Reality for Identification of Liver Lesions - a Pre-clinical Randomized Cross-over Trial N/A
Completed NCT06255080 - Comparing Skills Acquisition on Different Laparoscopy Software N/A
Enrolling by invitation NCT03234543 - Remote Ischemic Conditioning in Abdominal Surgery N/A
Recruiting NCT02827292 - Effect of Music on Inflammatory Response During Laparoscopic Surgery N/A
Not yet recruiting NCT06092684 - The Efficacy and Safety of Esketamine in Elective Laparoscopic Surgery Phase 3
Terminated NCT01008709 - Comparison Study of Two Different Surgical Clips During Laparoscopic Urologic Surgery N/A
Active, not recruiting NCT05363813 - Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery N/A
Completed NCT03330236 - EEG - Guided Anesthetic Care and Postoperative Delirium N/A
Recruiting NCT05031182 - Tolerance of the vNOTES Surgical Technique in Total Hysterectomy for Benign Lesion. Clinical Trial of Non-inferiority Compared to the Laparoscopic Technique. N/A
Active, not recruiting NCT05302622 - Detecting the Most Efficient Residency Time for Laparoscopic Simulators N/A
Recruiting NCT03684291 - Hemodynamic Effects of Ventilation Modes
Recruiting NCT06117748 - Volume-Controlled Ventilation and Pressure-Controlled Ventilation Volume Guaranteed in Obese Patients in Laparoscopic-Assisted Surgery N/A
Recruiting NCT03739944 - Different Surgical Approaches in Patients of Early-stage Cervical Cancer Phase 3