Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage
NCT ID: NCT05782062
Last Updated: 2023-05-19
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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WITHDRAWN
NA
INTERVENTIONAL
2023-04-15
2024-02-29
Brief Summary
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Blood clots in your dialysis access can be fairly common and prevent you from being able to get dialysis. Procedures for opening this blockage must then be performed which is why you have been sent to the hospital today. There are different ways of opening up this blockage which can including blowing up a balloon in multiple areas of the graft/fistula to squeeze the blood clot to break up the blockage or using a wire like device to break up the clot in small pieces and try to remove all of the clot from the wall of the graft/fistula.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Rotational Thrombectomy
Use of the Cleaner XT
Cleaner XT
Wire like device that rotates to allow for wall to wall disruption of thrombus.
Balloon Assisted maceration
Use of angioplasty balloons for balloon maceration
Balloon
Use of balloon for disrupting thrombus.
Interventions
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Cleaner XT
Wire like device that rotates to allow for wall to wall disruption of thrombus.
Balloon
Use of balloon for disrupting thrombus.
Eligibility Criteria
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Inclusion Criteria
* Age greater than 18
* Upper extremity dialysis graft/fistula
Exclusion Criteria
* Incarcerated
* Age under 18
* Inability to consent for self
* Graft/fistula in a location other than upper extremity
* Peritoneal dialysis
* Catheter dialysis
18 Years
ALL
Yes
Sponsors
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Argon Medical Devices
INDUSTRY
University of Alabama at Birmingham
OTHER
Responsible Party
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Junaid Yasin Raja
Assistant Professor
Other Identifiers
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IRB-300010783
Identifier Type: -
Identifier Source: org_study_id
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