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ANTERO-5: Gastric Motility in Postoperative Ileus

NCT04100265 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2021-02-10

No results posted yet for this study

Summary

A monocenter, non-randomized interventional investigation in 3 panels of adult patients undergoing elective colorectal surgery who are at risk to develop postoperative ileus.

The feasibility to use the VIPUN Gastric Monitoring System prototype 0.3 will be explored in this population for the first time.

Conditions

  • Postoperative Ileus

Interventions

DEVICE

Panel 1 - High risk for postoperative ileus (VIPUN Gastric Monitoring System)

The VIPUN Gastric Monitoring System prototype 0.3 comprises a nasogastric balloon catheter which is connected to an extracorporeal pressure sensor and data acquisition system. The device is placed during surgery.

DEVICE

Panel 2 - Postoperative ileus arm with investigational device (VIPUN Gastric Monitoring System)

The VIPUN Gastric Monitoring System prototype 0.3 comprises a nasogastric balloon catheter which is connected to an extracorporeal pressure sensor and data acquisition system. The device is placed upon the manifestation of clinical signs of postoperative ileus.

Sponsors & Collaborators

  • Universitaire Ziekenhuizen KU Leuven

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-16
Primary Completion
2021-01-21
Completion
2021-01-21

Countries

  • Belgium

Study Locations

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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 NCT04100265 on ClinicalTrials.gov