NCT04100265

ANTERO-5: Gastric Motility in Postoperative Ileus

ANTERO-5: A Clinical Investigation of Gastric Motility in Adult Patients at Risk to Develop Postoperative Ileus Following Colorectal Surgery

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Type	Name	Description
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.

Timeline

• Start date: 2019-10-16
• Primary completion: 2021-01-21
• Completion: 2021-01-21
• First posted: 2019-09-24
• Last updated: 2021-02-10

Locations

1 site across 1 country: Belgium