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NCT02332863 · ClinicalTrials.gov registry record · NA
Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.
A NA study, sponsored by University of Colorado, Denver.
- Completed
- Registry status
- NA
- Development phase
- 44
- Enrollment target
NCT02332863 is a NA study that has completed, run by University of Colorado, Denver. The registered enrollment target is 44 participants.
The verdict
NCT02332863, a NA study, has completed, sponsored by University of Colorado, Denver.
- COMPLETED
- Registry status
- NA
- Development phase
- 44 participants
- Enrollment target
Study Summary
Endoscopic ultrasound (EUS) has been pivotal in accomplishing image guided radiation therapy (IGRT) in patients with pancreatic cancer by allowing precise contouring and identification of target lesions in the pancreas via placement of fiducials using fine needle aspiration (FNA) needles. Currently, back-loading the fiducials is the only option for preparing delivery of fiducials via the EUS approach. A prototype 22-Gauge EUS needle preloaded with four fiducials has recently been developed, and used in a porcine models with successful results. There are no randomized controlled trials comparing total duration of time needed for placement of fiducials using technical success of the traditional back- loading technique of fiducial markers to the new preloaded needles in regards to EUS based fiducial marker placement for IGRT in pancreatic cancer. Hypotheses Use of a 22 G preloaded needle for EUS guided fiducial marker placement in patients with pancreatic cancer will: 1. Be delivered in at least require 60% less of the procedure time that it takes for traditional back-loaded 22G needles 2. Improve overall procedure efficiency 3. Maintain comparable technical success and adverse event rates. Primary Aims 1\) To compare the procedure time of 22G needle placement of three Visicoil (brand of flexible linear back-loaded fiducial markers) fiducial markers and 22G needle preloaded fiducial markers. Secondary Aims 1. To compare adverse event rates in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers 2. To compare endpoints of technical success defined as proper placement of two to three fiducial markers in a pancreatic neoplasm in 22G needle placement of Visicoil fiducial markers and 22G needle preloaded fiducial markers.
Interventions
- DEVICE Back-loaded Needle (Device)
- DEVICE Preloaded Needle (Device)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 44 participants |
| Start Date | 2016-08-03 |
| Est. Completion | 2020-05-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02332863
The ClinicalTrials.gov registry entry for NCT02332863 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 44 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Back-loaded Needle (Device) is the first listed.
NCT02332863 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02332863 about?
NCT02332863 is a clinical study titled "Comparison of Back-loaded vs Preloaded Fiducial Needles in EUS-guided Fiducial Marker Placement in Pancreatic Cancer.". Endoscopic ultrasound (EUS) has been pivotal in accomplishing image guided radiation therapy (IGRT) in patients with pancreatic cancer by allowing precise contouring and identification of target lesions in the pancreas via placement of fiducials using fine needle aspiration (FNA) needles. Currently,...
What is the current status of trial NCT02332863?
This trial is currently completed. It is a NA study. The enrollment target is 44 participants. The study started on 2016-08-03. Estimated completion is 2020-05-01.
What interventions are being tested in trial NCT02332863?
The interventions under investigation include: Back-loaded Needle (Device) (DEVICE), Preloaded Needle (Device) (DEVICE).
Who is sponsoring clinical trial NCT02332863?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
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