Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
NA
5 participants
INTERVENTIONAL
2019-10-16
2021-01-21
Brief Summary
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The feasibility to use the VIPUN Gastric Monitoring System prototype 0.3 will be explored in this population for the first time.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
The target population in each arm consists of 10 'completers'. Completers are defined as: Panel 1: A successful gastric motility recording of at least 6 hours
Panel 2: Patients who develop POI (estimated to be 10% of enrolled subjects) and in who gastric motility was recorded successfully for at least 6 hours
Panel 3: Patients who develop POI, who completed questionnaires for at least 2 days (with a questionnaire completion rate ≥50%).
DEVICE_FEASIBILITY
NONE
Study Groups
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Panel 1 - High risk for postoperative ileus
Intervention in patients at high risk to develop prolonged postoperative ileus. Monitoring postoperative gastric motility for 2 consecutive days in patients who require preventive placement of a nasogastric feeding tube due to a high risk to develop postoperative ileus. Allowing to explore associations between gastric motility and general clinical evolution.
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.
Panel 2 - Postoperative ileus arm with investigational device
Intervention in a population of patients with clinical signs of postoperative ileus, requiring a nasogastric feeding tube for symptom relief. The investigational medical device will be applied. Allowing to explore the association of gastric motility and clinical signs of postoperative ileus in an enriched population with true postoperative ileus.
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.
Panel 3 - Postoperative ileus arm with standard of care
Standard of care control group of patients with clinical signs of postoperative ileus requiring a standard nasogastric feeding tube for symptom relief. Symptoms will be surveyed as control group to assess safety and tolerability of the investigational medical device.
No interventions assigned to this group
Interventions
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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.
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least 18 years old
* BMI between and including 18 and 30
* Understand and able to read Dutch
* Planned to undergo elective colorectal surgery
Exclusion Criteria
* Known history of functional dyspepsia
* Known / suspected current use of illicit drugs
* Known psychiatric or neurological illness
* Any prior gastrointestinal surgery that could influence normal gastric function in the opinion of the investigator
* Known history of heart or vascular diseases like irregular heartbeats, angina or heart attack
* Nasopharyngeal surgery in the last 30 days
* Suspected basal skull fracture or severe maxillofacial trauma
* Known history of thermal or chemical injury to upper respiratory tract or esophagus
* Current esophageal or nasopharyngeal obstruction
* Known coagulopathy
* Known esophageal varices
18 Years
ALL
No
Sponsors
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Universitaire Ziekenhuizen KU Leuven
OTHER
Responsible Party
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Locations
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UZ Leuven
Leuven, , Belgium
Countries
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Other Identifiers
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S63029
Identifier Type: -
Identifier Source: org_study_id
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