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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT04100265
Other study ID # S63029
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date October 16, 2019
Est. completion date January 21, 2021

Study information

Verified date November 2019
Source Universitaire Ziekenhuizen Leuven
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 5
Est. completion date January 21, 2021
Est. primary completion date January 21, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Signed Informed Consent - 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 documented gastroparesis - 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

Study Design


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
Belgium UZ Leuven Leuven

Sponsors (1)

Lead Sponsor Collaborator
Universitaire Ziekenhuizen Leuven

Country where clinical trial is conducted

Belgium, 

Outcome

Type Measure Description Time frame Safety issue
Primary Feasibility (composite endpoint) Composite endpoint comprising: procedural success (absence of protocol deviations with regard to motility measurement), tolerability of the device (non-validated questionnaire on nasopharyngeal discomfort and the incidence of intolerance resulting in early removal of the investigational device) and device-related safety (incidence of adverse device effects related to the use of the device). Day 1 - Day 14
Secondary Gastric motility Long term motility index Day 1 until termination motility recording (maximum 48 hours)
Secondary Evolution postoperative ileus - staff reported Incidence of markers of resolution of postoperative ileus (first flatus, bowel sounds, bowel movements, solid food tolerance) Day 1 until completion study procedures (maximum 14 days).
Secondary In hospital quality of life (EQ-5D-3L questionnaire) EQ-5D-3L questionnaire consists of 2 pages: EQ-5D descriptive system and an EQ visual analogue scale (EQ VAS).
EQ-5D-3L (not an acronym) descriptive system comprises the following five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 3 levels: no problems, some problems, and extreme problems. The five dimensions can be combined into a 5-digit number that describes the patient's health state. EQ VAS records the patient's self-rated health on a vertical visual analogue scale where the endpoints are labelled 'Best imaginable health state' and 'Worst imaginable health state'.
Day 1 until completion study procedures (maximum 14 days)
Secondary Device performance Incidence of device deficiencies Day 1 until removal of device, no later than Day 14
Secondary Nausea severity Patient reported severity of nausea (100 mm visual analogue scale ranging from Absent to Worst possible) Day 1 until completion study procedures (maximum 14 days)
Secondary Abdominal bloating severity Patient reported severity of abdominal bloating (100 mm visual analogue scale ranging from Absent to Worst possible) Day 1 until completion study procedures (maximum 14 days)
Secondary Abdominal pain severity Patient reported severity of abdominal pain (100 mm visual analogue scale ranging from Absent to Worst possible) Day 1 until completion study procedures (maximum 14 days)
Secondary Abdominal discomfort severity Patient reported severity of abdominal discomfort (100 mm visual analogue scale ranging from Absent to Worst possible) Day 1 until completion study procedures (maximum 14 days)
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