New pump could make dialysis access easier for kidney patients
NCT ID NCT07211035
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device called the Amplifi Vein Dilation System, which is a temporary blood pump used before creating a dialysis access point (fistula) in the arm. The goal is to see if it helps widen small veins so the fistula works better for dialysis. About 160 adults with end-stage kidney disease who need dialysis will take part. Some will get the device plus standard fistula surgery, while others will have surgery alone.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Amplifi Vein Dilation System (a temporary blood pump device)
- What this could lead to
- If it works, this device could help more kidney patients get working dialysis access without needing extra surgeries or catheters.
- What could go wrong
- This is an early-stage device trial with 160 participants, so results may not apply to everyone. There are risks from the pump and vein procedure, including injury or infection.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 160 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Dec 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age ≥ 18 years 2. Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice 3. End-Stage Renal Disease (ESRD) receiving maintenance hemodialysis. 4. Baseline cephalic vein diameter between \>1.7 mm and \<3.2 mm at the proposed Study AVF creation site in the distal forearm, with a continuous distal segment or tributary suitable for Amplifi System Outflow Catheter placement, including: * A forearm cephalic vein segment of ≥ 14 cm in length that provides an approximately 10 cm cannulation zone, free of detectable occlusions or stenosis, with collaterals. * Central continuity of the forearm cephalic vein at the elbow demonstrated through one or any combination of the following pathways: 1. the upper arm cephalic vein, 2. the median cubital vein connecting to the upper arm basilic vein, 3. the perforator vein connecting to the deep venous system. * Upper arm veins must show central continuity with no detectable occlusions. 5. Palpable radial artery with a diameter of ≥ 2.0 mm at the site of proposed AVF creation without significant stenosis along the course 6. Positive Allen's Test 7. At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion 8. Subject has voluntarily signed written informed consent Exclusion Criteria: 1. Known allergy to Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban 2. Known or suspected active infection at the proposed time of Amplifi System placement 3. Known bleeding diathesis, including from uncorrected coagulopathy 4. Known thrombophilia, requiring treatment 5. Hb \<7 gm/dL 6. Platelet level \< 100,000 /mm3 7. Significant radial artery calcification 8. Need for continued treatment with anti-platelet agents or other anticoagulants (other than apixaban) during the Amplifi System treatment period 9. Known history of patent foramen ovale \> 2 mm 10. History of recent intracranial or gastrointestinal bleeding 11. Documented recent central venous or right atrial thrombus 12. Known presence or recent history of intracranial or gastrointestinal bleeding or presence of underlying conditions that would predispose to intracranial or internal bleeding. Documented recent central venous or right atrial thrombus 13. History of recent ipsilateral central venous occlusion, stenosis \> 50%, angioplasty, or stent placement 14. Pregnancy, lactation, or plans to become pregnant during the Study 15. Expected survival less than 12 months 16. Unwillingness or inability to comply with procedures specified in the Protocol, or difficulty or inability to return for follow-up visits as specified by the Protocol 17. Participation in any other investigational drug or medical device study that has not completed primary endpoint evaluation or clinically interferes with the endpoints from the Study, or planned future participation in such studies prior to the completion of the Study
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Brigham Women's Hospital
RECRUITINGBoston, Massachusetts, 02115, United States
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Flow Vascular
RECRUITINGHouston, Texas, 77091, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Fluid overload hides true lung pressure in dialysis patients, study aims to unmask it
- Diabetes drug semaglutide tested in dialysis patients for safety
- New graft could make dialysis easier for kidney patients
- Mismatched kidney transplants boost survival in seniors
- Could permanent dialysis access replace catheters in ICU kidney therapy?