End Stage Renal Failure, HemodialysisaXess4AllNCT07925502
Post Market Clinical Follow-Up Registry Study of the aXess Hemodialysis Conduit
A study testing Xeltis aXess Hemodialysis Conduit in people with End Stage Renal Failure, Hemodialysis, run by Xeltis.
Trial summary
A prospective, single arm, non-randomized Post Market Clinical Follow-up (PMCF) registry study to evaluate the safety and performance of the aXess Hemodialysis Conduit, called aXess4All. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Failure, Hemodialysis
- What is being tested?
- Xeltis aXess Hemodialysis Conduit
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 350 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Dec 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.
About this study
Official title: Prospective, Single Arm, Non-randomized PMCF Registry Study to Evaluate the Safety and Performance of the aXess Hemodialysis Conduit.
A prospective, single arm, non-randomized Post Market Clinical Follow-up (PMCF) registry study to evaluate the safety and performance of the aXess Hemodialysis Conduit, called aXess4All. Intended for Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.
- Conditions
- End Stage Renal Failure, Hemodialysis
- Being tested
- Xeltis aXess Hemodialysis Conduit
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Xeltis aXess Hemodialysis ConduitDevice
The aXess Hemodialysis Conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess Hemodialysis Conduit is able to support both straight and loop configurations and may be implanted in the upper arm or forearm.
| Study group | Role | What they receive |
|---|---|---|
| aXess | Experimental | Not described Receives: Device: Xeltis aXess Hemodialysis Conduit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freedom from major aXess infection
Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation.
Measured: 12 months post-implant
Secondary outcomes (5)
Primary, primary-assisted and secondary patency
Primary patency: Defined as the interval between vascular access creation and the first intervention to maintain or restore patency.
Assisted primary patency: Defined as the interval between vascular access creation and the first occlusion (thrombosis), including interventions (operative or endovascular) aimed to maintain the functionality of the vascular access.
Secondary patency: Defined as the interval between vascular access creation and abandonment with or without interventions (operative or endovascular) aimed to maintain or restore the functionality the vascular access, including occurrence of a censored event (death, change of modality, loss of follow-up).
Measured: 6, 12, 24, 36, 48 months post-implant
Freedom from major aXess infection
Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation.
Measured: 6, 24, 36, 48 months post-implant
Rate of interventions to maintain or restore patency
Measured: 6, 12, 24, 36, 48 months post-implant
Rate of interventions to treat pseudoaneurysms
Measured: 6, 12, 24, 36, 48 months post-implant
Rate of treatment failures
Treatment failure defined as patients that had an implant attempted but are discharged without a functional aXess Hemodialysis Conduit
Measured: Day 0 post-implant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2026
- Study startNov 2026 (estimated)
- Primary completionDec 2030 (estimated)
- Study completionDec 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal Failure, HemodialysisStudies 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
- 350 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xeltis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07925502
- Sponsor's protocol ID
- XEL-CR-16
- Acronym
- aXess4All
- Status last verified
- Nov 2026
- First submitted
- 3 Nov 2026
- Last updated
- 9 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 9 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Arm, Non-randomized PMCF Registry Study to Evaluate the Safety and Performance of the aXess Hemodialysis Conduit.
- ClinicalTrials.gov ID
- NCT07925502
- Acronym / sponsor ID
- aXess4All / XEL-CR-16
- Conditions
- End Stage Renal Failure, Hemodialysis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 350 participants (estimated)
- Lead sponsor
- XeltisIndustry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- Dec 2030 (estimated)
- Study completion
- Dec 2033 (estimated)
- First posted
- 9 Nov 2026 (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.
A prospective, single arm, non-randomized Post Market Clinical Follow-up (PMCF) registry study to evaluate the safety and performance of the aXess Hemodialysis Conduit, called aXess4All. Intended for Patients older than 18 years of age with end-stage renal disease who require a vascular access for hemodialysis, compliant with the Instructions for Use who consented in study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| aXess | Experimental | Device: Xeltis aXess Hemodialysis Conduit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Xeltis aXess Hemodialysis ConduitThe aXess Hemodialysis Conduit is a sterile, regenerative biodegradable polymer-based vascular conduit, consisting of a tubular structure with a 6mm inner diameter. It is comprised of a highly porous polymer matrix and an embedded electropolished nitinol reinforcement layer (Strain Relief System). The aXess Hemodialysis Conduit is able to support both straight and loop configurations and may be implanted in the upper arm or forearm. | Device | aXess |
Primary outcome
Freedom from major aXess infection
Time frame: 12 months post-implant
Major aXess infection defined as conduit-related infections resulting in (partial) aXess Hemodialysis Conduit explantation.
5 secondary outcomes
Primary, primary-assisted and secondary patency
Time frame: 6, 12, 24, 36, 48 months post-implant
Freedom from major aXess infection
Time frame: 6, 24, 36, 48 months post-implant
Rate of interventions to maintain or restore patency
Time frame: 6, 12, 24, 36, 48 months post-implant
Rate of interventions to treat pseudoaneurysms
Time frame: 6, 12, 24, 36, 48 months post-implant
Rate of treatment failures
Time frame: Day 0 post-implant
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Nov 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.
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 Xeltis aXess Hemodialysis Conduit in people with End Stage Renal Failure, Hemodialysis, run by Xeltis.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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: opening soon, as of the sponsor's last update on 9 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Freedom from major aXess infection (time frame: 12 months post-implant). 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 9 Nov 2026.