Dialysis Access MalfunctionBARTNCT05782062
Balloon Assisted Maceration Versus Rotational Thrombectomy in Dialysis Access Salvage
A study testing Cleaner XT and Balloon in people with Dialysis Access Malfunction and Dialysis; Complications, run by University of Alabama at Birmingham.
Trial summary
The purpose of this research study is to compare how well a wire like device disrupts and removes blood clot in your blocked dialysis graft/fistula in comparison to inflating a balloon in your access for the same purpose. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dialysis Access Malfunction, Dialysis; Complications
- What is being tested?
- Cleaner XT and Balloon
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 15 Apr 2023to 29 Feb 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- End stage renal disease on hemodialysis
- Age greater than 18
- Upper extremity dialysis graft/fistula
Who cannot join
- Pregnant
- Incarcerated
- Age under 18
- Inability to consent for self
- Graft/fistula in a location other than upper extremity
- Peritoneal dialysis
- Catheter dialysis
About this study
Official title: Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy
The purpose of this research study is to compare how well a wire like device disrupts and removes blood clot in your blocked dialysis graft/fistula in comparison to inflating a balloon in your access for the same purpose. The wire like device is called the Cleaner XT and has already been approved by the government/Food and Drug Administration (FDA) for this purpose.
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.
- Being tested
- Cleaner XT, Balloon
- Keywords
- Thrombosis of dialysis access
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cleaner XTDevice
Wire like device that rotates to allow for wall to wall disruption of thrombus.
BalloonDevice
Use of balloon for disrupting thrombus.
| Study group | Role | What they receive |
|---|---|---|
| Rotational Thrombectomy | Experimental | Use of the Cleaner XT Receives: Device: Cleaner XT |
| Balloon Assisted maceration | Active comparator | Use of angioplasty balloons for balloon maceration Receives: Device: Balloon |
What is being measured
The primary outcome is the main question the study is designed to answer.
Secondary patency
How long the dialysis access remains functional after the procedure.
Measured: 6 months post procedurally
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2023
- Study start15 Apr 2023 (estimated)
- Primary completion29 Feb 2024 (estimated)
- Study completion29 Feb 2024 (estimated)
Why it stopped: funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dialysis Access MalfunctionStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Argon Medical Devices
- Responsible party
- Principal investigator, Junaid Yasin Raja, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05782062
- Sponsor's protocol ID
- IRB-300010783
- Acronym
- BART
- Status last verified
- May 2023
- First submitted
- 12 Mar 2023
- Last updated
- 19 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacomechanical Dialysis Access Salvage With Balloon Assisted Maceration Versus Rotational Thrombectomy
- ClinicalTrials.gov ID
- NCT05782062
- Acronym / sponsor ID
- BART / IRB-300010783
- Keywords
- Thrombosis of dialysis access
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Argon Medical Devices
- Study start
- 15 Apr 2023 (estimated)
- Primary completion
- 29 Feb 2024 (estimated)
- Study completion
- 29 Feb 2024 (estimated)
- First posted
- 23 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this research study is to compare how well a wire like device disrupts and removes blood clot in your blocked dialysis graft/fistula in comparison to inflating a balloon in your access for the same purpose. The wire like device is called the Cleaner XT and has already been approved by the government/Food and Drug Administration (FDA) for this purpose.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Rotational Thrombectomy | Experimental | Device: Cleaner XTUse of the Cleaner XT |
| Balloon Assisted maceration | Active comparator | Device: BalloonUse of angioplasty balloons for balloon maceration |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- End stage renal disease on hemodialysis
- Age greater than 18
- Upper extremity dialysis graft/fistula
Key exclusion criteria (7 listed)
- Pregnant
- Incarcerated
- Age under 18
- Inability to consent for self
- Graft/fistula in a location other than upper extremity
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cleaner XTWire like device that rotates to allow for wall to wall disruption of thrombus. | Device | Rotational Thrombectomy |
| BalloonUse of balloon for disrupting thrombus. | Device | Balloon Assisted maceration |
Primary outcome
Secondary patency
Time frame: 6 months post procedurally
How long the dialysis access remains functional after the procedure.
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Cleaner XT and Balloon in people with Dialysis Access Malfunction and Dialysis; Complications, run by University of Alabama at Birmingham.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Secondary patency (time frame: 6 months post procedurally). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.