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NCT02053571 · ClinicalTrials.gov registry record · NA
Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure
A NA study of Portal Hypertension, sponsored by Medical College of Wisconsin.
- Completed
- Registry status
- NA
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT02053571 is a NA study of Portal Hypertension that has completed, run by Medical College of Wisconsin. The registered enrollment target is 20 participants, below the 207-participant average among 9 other Portal Hypertension trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02053571, a NA study of Portal Hypertension, has completed, sponsored by Medical College of Wisconsin.
- COMPLETED
- Registry status
- NA
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to evaluate an alternate approach, which involves using a 3D puncture path overlay, to access the portal vein during a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The study should determine if the alternate approach provides these benefits: improved safety of procedure, and reduced intervention time (including reduction of radiation exposure), which benefits both interventional radiologist and the patient. During a TIPS procedure, a shunt or stent (mesh tube) is passed down the jugular vein (the vein above the collarbone in the neck) using fluoroscopy (x-ray) guidance. The shunt then is inserted between the portal vein (vein that carries blood from the digestive organs into the liver) to a hepatic vein (vein that carries blood away from the liver back to the heart). In the standard approach, the interventional radiologist uses two-dimensional guidance (2D - having the dimensions of height and width only) to locate the path between the portal vein and hepatic vein. However, since these two veins do not connect, this method does not provide information on the three-dimensional (3D) relationship between the two veins. In the alternate approach, the physician will have the option of using 3D guidance to locate the path. An on-table limited (small field of view) CT scan, used in combination with FDA approved imaging software, will provide a 3D image demonstrating the relationship between the portal vein and the hepatic vein. The 3D image is overlaid on the standard live x-ray images to assist in needle guidance during the TIPS procedure. The CT scan performed will be in place of the angiograms that are typically performed. However, if the portal vein is not adequately seen in the CT images, the angiograms will be done and there will be no overlay. The procedure will proceed using the standard approach.
Conditions Studied
Interventions
- PROCEDURE TIPS with 3D Overlay
Study Locations (1)
Wisconsin
- Medical College of Wisconsin/Froedtert Memorial Lutheran Hospital - Milwaukee
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2014-04 |
| Est. Completion | 2016-08-04 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02053571
The ClinicalTrials.gov registry entry for NCT02053571 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 207-participant average among 9 other Portal Hypertension trials with a reported enrollment target (90% lower). The listed sponsor is Medical College of Wisconsin, which has 447 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Portal Hypertension appearing as the primary indexed condition, and to 1 intervention - of which TIPS with 3D Overlay is the first listed.
NCT02053571 reports 1 study location spanning 1 distinct geographic area - top geographies include Wisconsin.
Frequently Asked Questions
What is clinical trial NCT02053571 about?
NCT02053571 is a clinical study titled "Evaluation of 3D Overlay During Transjugular Intrahepatic Portosystemic Shunt (TIPS) Procedure". The goal of this study is to evaluate an alternate approach, which involves using a 3D puncture path overlay, to access the portal vein during a Transjugular Intrahepatic Portosystemic Shunt (TIPS) procedure. The study should determine if the alternate approach provides these benefits: improved safe...
What is the current status of trial NCT02053571?
This trial is currently completed. It is a NA study. The enrollment target is 20 participants. The study started on 2014-04. Estimated completion is 2016-08-04.
What conditions does trial NCT02053571 study?
This clinical trial studies the following conditions: Portal Hypertension.
What interventions are being tested in trial NCT02053571?
The interventions under investigation include: TIPS with 3D Overlay (PROCEDURE).
Who is sponsoring clinical trial NCT02053571?
This trial is sponsored by Medical College of Wisconsin, which has 447 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02053571 being conducted?
This trial has 1 study location across Wisconsin. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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