A randomized trial comparing the CORTRAK system with the endoscopic technique for duodenal feeding tube placement

A randomized trial comparing the CORTRAK system with the endoscopic technique for duodenal feeding tube placement - CORRECT study

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON41400

Enrollment

309

Registered

2013-04-02

Start date

2013-12-09

Completion date

Unknown

Last updated

2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

duodenul feeding tube placement

Interventions

Patients will be randomized to undergo DFT placement with the CORTRAK system or the endoscopic technique.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - All patients needing a duodenal feeding tube - Written informed consent provided by patient or representative - *18 years

Exclusion criteria

Exclusion criteria: - Implantable pacing devices (potential interference with the signal transmission) - Altered anatomy of the upper gastrointestinal tract due to surgery of the esophagus, stomach or duodenum - High suspicion of stenosis or obstruction in the upper digestive tract - Esophageal varices - Signs of active upper gastrointestinal bleeding. - Woman with known pregnancy (because of abdominal X-rays performed in order to confirm location of the DFT)

Design outcomes

Primary

Measure	Time frame
Success rate of DFT placement; defined as the tip of the tube placed postpyloric and into the duodenum as confirmed by an abdominal X-ray.	—

Secondary

Measure	Time frame
Costs associated with DFT placement, procedure time, difficulty of the procedure, accuracy of tip location with CORTRAK, DFT tip location, safety, use of sedatives, reintervention rate within 10 days and patient acceptance (in unsedated patients).	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)