The Turbine-based Insufflator Safety and Feasibility Study

NCT06319053 | Completed DMC

• 1 other identifier: NL85402.078.23
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Pneumoperitoneum; Device development; Insufflator; Laparoscopy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Observation of insufflation pressure stability by continuously monitoring and recording.

  During the surgical procedure

• Gas volume exchange

  During the surgical procedure

• Estimation of the abdominal compliance

  <6 months after the surgical procedure

• Intra-abdominal target pressure in relation to the abdominal compliance

  <6 months after the surgical procedure

Study Arms (1)

Laparoscopy

EXPERIMENTAL

Adult study participants who are planned to undergo intraperitoneal laparoscopic surgery

Device: Turbine-based insufflator

Interventions

Turbine-based insufflator DEVICE

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

Laparoscopy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult
• Elective laparoscopic surgery
• Intraperitoneal procedure
• Planned use of a main 11 mm trocar
• Informed consent

You may not qualify if:

• Pregnancy
• Inability to contain the insufflation gas to the intraperitoneal cavity

Sponsors & Collaborators

• Erasmus Medical Center: lead
• Politecnico di Milano University: collaborator
• Health∼Holland, Topsector Life Sciences & Health: collaborator
• Spatium Medical B.V.: collaborator
• IDE Group B.V.: collaborator

Study Sites (1)

Erasmus MC, University Medical Center Rotterdam

Rotterdam, South Holland, 3015 GD, Netherlands

Location

MeSH Terms

Conditions

Pneumoperitoneum

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Study Officials

• J. Vlot, MD, PhD

  Erasmus MC, University Medical Center Rotterdam

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Consultant pediatric surgeon

Model Details: 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

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 19, 2024
• Study Start: April 3, 2024
• Primary Completion: October 1, 2024
• Study Completion: October 1, 2024
• Last Updated: November 5, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)