End-Stage Renal Disease Requiring HaemodialysisAmplifi FIHNCT07058610
Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
A study testing Amplifi Vein Dilation System in people with End-Stage Renal Disease Requiring Haemodialysis, run by Amplifi Vascular, Inc. at 1 site in Paraguay.
Trial summary
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End-Stage Renal Disease Requiring Haemodialysis
- What is being tested?
- Amplifi Vein Dilation System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19 participants
- Where
- 1 siteParaguay
- Study dates
- 8 Dec 2020to 11 Jun 2025
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years
- Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
- ESRD currently receiving maintenance hemodialysis via a tunneled, cuffed hemodialysis catheter
- Baseline wrist or distal forearm cephalic vein diameter of >= 1.7 mm and < 3.2 mm at the proposed Study AVF creation site, wherein the wrist or forearm cephalic vein at the proposed Study AVF creation site is suitable for Amplifi Distal Outflow Catheter placement and Amplifi System treatment, including:
- >= 1.7 mm to < 3.2 mm diameter of the wrist or forearm cephalic vein at the proposed Study AVF creation site;
- patency and continuity of blood flow from the proposed Study AVF creation site centrally to the upper arm at the elbow through at least one or more of: 1) the upper arm cephalic vein; 2) the median cubital vein to the upper arm basilic system; or 3) the perforator vein to the deep venous system; and
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- no occlusion or stenosis > 50% along the course of the forearm cephalic vein and at least one upper arm venous outflow up to the subclavian vein, as determined by duplex ultrasonography
- Estimated forearm hemodialysis needle cannulation zone length > 18 cm after creation of the proposed Study AVF
- At least one patent internal jugular vein suitable for Amplifi Inflow Catheter insertion
- Subject has voluntarily signed written informed consent
Who cannot join
- Known allergy or hypersensitivity to any Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban
- Known or suspected active infection at the proposed time of Amplifi System placement
- Known bleeding diathesis, including uncorrected coagulopathy
- Known thrombophilia requiring treatment
- Hemoglobin < 10 g/dL
- Platelet count < 100,000/mm³
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- Requirement for continued treatment with antiplatelet agents or anticoagulants other than apixaban during the Amplifi System treatment period
- Known history of patent foramen ovale > 2 mm
- History of recent intracranial or gastrointestinal bleeding
- Documented recent central venous or right atrial thrombus
- History of recent ipsilateral central venous occlusion, > 50% stenosis, angioplasty, or stent placement
- Pregnancy, lactation, or plans to become pregnant during the study
- Unwillingness or inability to comply with protocol-specified procedures or follow-up visits
- Participation in another investigational drug or medical device study that has not completed primary endpoint evaluation, that could clinically interfere with study endpoints, or planned participation in such a study prior to completion of this study
Trial locations and contacts
1 site in 1 country.
About this study
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.
Read the detailed description
The Amplifi System was used to promote vein dilation prior to AVF creation. Subjects with ESRD or CKD were treated across three phases of enrollment. The protocol incorporated learnings from earlier phases, including improvements to the device design and procedural protocols. This registration covers all phases of the study (Phase 1-3), with updates planned as new data becomes available.
- Being tested
- Amplifi Vein Dilation System
- Keywords
- Amplifi, Pre-dilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amplifi Vein Dilation SystemDevice
An investigational extracorporeal blood pump and catheter system designed to promote vein dilation prior to AVF creation.
| Study group | Role | What they receive |
|---|---|---|
| Interventional arm | Experimental | Single arm study Receives: Device: Amplifi Vein Dilation System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of AVF Maturation at 2 and 6 Weeks
Measured: From post AVF creation to end of 6 weeks follow-up.
Percent Change in Cephalic Vein Diameter and Blood Flow
Measured: From baseline, during Amplifi System treatment (minimum daily), and prior to Amplifi System removal and AVF creation]
Mean vein diameter of the cephalic vein and blood flow of brachial artery
Measured: 2 and 6 weeks post AVF creation
Percentage of subjects who experience an increase in the cephalic vein diameter of ≥2.7 mm from their baseline measurement, or an increase of >1 mm from baseline, following treatment with the Amplifi System.
Measured: From baseline measurement to intra-procedural assessment immediately prior to Amplifi System removal and AVF creation (same procedure day)
Rate of Occurrence of Major Device-Related Adverse Events
Measured: from device implantation and up to 30 days from device removal and AVF creation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start8 Dec 2020
- Primary completion11 Jun 2025
- Study completion11 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End-Stage Renal Disease Requiring HaemodialysisStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amplifi Vascular, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058610
- Sponsor's protocol ID
- CLINP1837
- Acronym
- Amplifi FIH
- Status last verified
- Jul 2025
- First submitted
- 1 Jul 2025
- Last updated
- 2 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amplifi Vein Dilation System Treatment on Radiocephalic AVF Maturation-3
- ClinicalTrials.gov ID
- NCT07058610
- Acronym / sponsor ID
- Amplifi FIH / CLINP1837
- Keywords
- Amplifi, Pre-dilation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Amplifi Vascular, Inc.Industry (pharma, biotech, devices)
- Study start
- 8 Dec 2020 (actual)
- Primary completion
- 11 Jun 2025 (actual)
- Study completion
- 11 Jun 2025 (actual)
- First posted
- 10 Jul 2025 (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.
This multi-phase clinical study evaluated the safety and performance of the Amplifi Vein Dilation System (Amplifi System) in subjects requiring arteriovenous fistula (AVF) creation. Conducted at a single site outside the United States, subjects were enrolled across multiple phases. The study focused on device-related safety, procedural success, percent change in vein dilation and AVF maturation outcomes.
Detailed description
The Amplifi System was used to promote vein dilation prior to AVF creation. Subjects with ESRD or CKD were treated across three phases of enrollment. The protocol incorporated learnings from earlier phases, including improvements to the device design and procedural protocols. This registration covers all phases of the study (Phase 1-3), with updates planned as new data becomes available.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Interventional arm | Experimental | Device: Amplifi Vein Dilation SystemSingle arm study |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age ≥ 18 years
- Indicated for wrist or distal forearm radiocephalic AVF creation based on Investigator's standard practice
- ESRD currently receiving maintenance hemodialysis via a tunneled, cuffed hemodialysis catheter
- Baseline wrist or distal forearm cephalic vein diameter of >= 1.7 mm and < 3.2 mm at the proposed Study AVF creation site, wherein the wrist or forearm cephalic vein at the proposed Study AVF creation site is suitable for Amplifi Distal Outflow Catheter placement and Amplifi System treatment, including:
- Estimated forearm hemodialysis needle cannulation zone length > 18 cm after creation of the proposed Study AVF
Key exclusion criteria (14 listed)
- Known allergy or hypersensitivity to any Amplifi System components (polyurethane, nitinol), iodinated contrast agents, heparin, or apixaban
- Known or suspected active infection at the proposed time of Amplifi System placement
- Known bleeding diathesis, including uncorrected coagulopathy
- Known thrombophilia requiring treatment
- Hemoglobin < 10 g/dL
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 |
|---|---|---|
| Amplifi Vein Dilation SystemAn investigational extracorporeal blood pump and catheter system designed to promote vein dilation prior to AVF creation. | Device | Interventional arm |
Primary outcome
Rate of AVF Maturation at 2 and 6 Weeks
Time frame: From post AVF creation to end of 6 weeks follow-up.
Percent Change in Cephalic Vein Diameter and Blood Flow
Time frame: From baseline, during Amplifi System treatment (minimum daily), and prior to Amplifi System removal and AVF creation]
Mean vein diameter of the cephalic vein and blood flow of brachial artery
Time frame: 2 and 6 weeks post AVF creation
Percentage of subjects who experience an increase in the cephalic vein diameter of ≥2.7 mm from their baseline measurement, or an increase of >1 mm from baseline, following treatment with the Amplifi System.
Time frame: From baseline measurement to intra-procedural assessment immediately prior to Amplifi System removal and AVF creation (same procedure day)
Rate of Occurrence of Major Device-Related Adverse Events
Time frame: from device implantation and up to 30 days from device removal and AVF creation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Amplifi Vein Dilation System in people with End-Stage Renal Disease Requiring Haemodialysis, run by Amplifi Vascular, Inc. at 1 site in Paraguay.
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 10 inclusion and 14 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: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Paraguay. Whether a site is taking part right now should be confirmed with that site. See every site.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Rate of AVF Maturation at 2 and 6 Weeks (time frame: From post AVF creation to end of 6 weeks follow-up.). The study lists 5 primary outcomes in all. 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 2 Jan 2026.