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The Turbine-based Insufflator Safety and Feasibility Study

NCT06319053 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2024-11-05

No results posted yet for this study

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.

Conditions

  • Laparoscopy
  • Pneumoperitoneum

Interventions

DEVICE

Turbine-based insufflator

The use of a turbine-based insufflator instead of a conventional insufflator

Sponsors & Collaborators

  • Politecnico di Milano University

    collaborator UNKNOWN

  • Health∼Holland, Topsector Life Sciences & Health

    collaborator UNKNOWN

  • Spatium Medical B.V.

    collaborator UNKNOWN

  • IDE Group B.V.

    collaborator UNKNOWN

  • Erasmus Medical Center

    lead OTHER

Principal Investigators

  • J. Vlot, MD, PhD · Erasmus MC, University Medical Center Rotterdam

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-04-03
Primary Completion
2024-10-01
Completion
2024-10-01

Countries

  • Netherlands

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06319053 on ClinicalTrials.gov