End-Stage Renal Disease Requiring HaemodialysisDisTalNCT07786025

DisTal Arterio-Venous Fistula Feasibility

A study testing DisTal in people with End-Stage Renal Disease Requiring Haemodialysis, run by Distal Inc. at 1 site in Dominican Republic.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: End-Stage Renal Disease Requiring Haemodialysis
What is being tested?: DisTal
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 100 participants
Where: 1 siteDominican Republic
Study dates: 2 Dec 2024to 1 Mar 2027
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

Who may be able to join

Age ≥ 18.
End Stage Renal Disease (ESRD) requiring hemodialysis.
Having a patent cephalic vein at the wrist /forearm.
Signed informed consent.

Who cannot join

Pregnancy or lactation.
Known central venous stenosis on the same side as the planned AVF creation.
Prior surgically created access in the planned treatment location.
Evidence of active infections at the time of study enrollment.
Known uncontrolled abnormal coagulation status and are at additional risk for clotting or excessive bleeding.
Prisoner.
Employee of the Sponsor.

Trial locations and contacts

1 site in 1 country.

Dominican Republic1 site

Clinica Canela
La Romana

Other trials in Dominican Republic

About this study

Official title: Feasibility Study to Assess the Safety and Efficacy of the DisTal Arterio-Venous Fistula Procedure

The goal of this clinical trial is to evaluate, in a clinical setting, the feasibility of vein enlargement at the site of the arteriovenous fistula created percutaneously, using the DisTal device ("DisTal AVF"). The main question the study aims to answer is what is the rate of successful enlargement of the vein at the site of DisTal AVF within 100 days of the procedure, as confirmed by ultrasound.

Conditions: End-Stage Renal Disease Requiring Haemodialysis
Being tested: DisTal
Keywords: DisTal, arteriovenous, fistula, radial, AVF
Medical subject headings: Fistula

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

DisTalDevice
To create a DisTal arteriovenous fistula, the radial vein and radial artery are accessed percutaneously. Venous and arterial guidewires are inserted-with the arterial wire navigating from the vein into the artery-and aligned in position. The DisTal device, featuring a circular blade on a torque shaft, is advanced over both wires. As it advances, DisTal pulls the vessels together while the blade cuts a 7-10 mm opening between the adjoining artery and vein, establishing a non-surgical, endovascular arteriovenous fistula that allows direct blood flow.

Study groups in NCT07786025
Study group	Role	What they receive
DisTal	Experimental	If the eligibility criteria are fulfilled, participants undergo procedure during which DisTal is used to establish a percutaneous arteriovenous fistula ("DisTal AVF"). Receives: Device: DisTal

What is being measured

The primary outcome is the main question the study is designed to answer.

Percutaneous DisTal AVF vein enlargement success rate
Proportion of participants in whom the vein at the site of the DisTal AVF exhibits enlargement compared to the pre-procedural values, as confirmed by ultrasound.
Measured: within 100 days of establishing DisTal AVF

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

2 Dec 20241 Mar 2027

First posted25 Aug 2026
Study start2 Dec 2024
Primary completion1 Mar 2027 (estimated)
Study completion1 Mar 2027 (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 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: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07786025
Sponsor's protocol ID: CLD-001
Acronym: DisTal
Status last verified: Aug 2026
First submitted: 21 Aug 2026
Last updated: 25 Aug 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
Not yet recruitingObservational study
Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan
Coronary Artery Calcification, Cardiovascular Risk
RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
Chronic Kidney Disease (CKD) Stage 5, Kidney Dysfunction Requiring Dialysis (KDRD)

All End-Stage Renal Disease Requiring Haemodialysis trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Feasibility Study to Assess the Safety and Efficacy of the DisTal Arterio-Venous Fistula Procedure
ClinicalTrials.gov ID: NCT07786025
Acronym / sponsor ID: DisTal / CLD-001
Conditions: End-Stage Renal Disease Requiring Haemodialysis
Keywords: DisTal, arteriovenous, fistula, radial, AVF
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 100 participants (actual)
Lead sponsor: Distal Inc.Industry (pharma, biotech, devices)
Study start: 2 Dec 2024 (actual)
Primary completion: 1 Mar 2027 (estimated)
Study completion: 1 Mar 2027 (estimated)
First posted: 25 Aug 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.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DisTal	Experimental	Device: DisTalIf the eligibility criteria are fulfilled, participants undergo procedure during which DisTal is used to establish a percutaneous arteriovenous fistula ("DisTal AVF").

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Age ≥ 18.
End Stage Renal Disease (ESRD) requiring hemodialysis.
Having a patent cephalic vein at the wrist /forearm.
Signed informed consent.

Key exclusion criteria (7 listed)

Pregnancy or lactation.
Known central venous stenosis on the same side as the planned AVF creation.
Prior surgically created access in the planned treatment location.
Evidence of active infections at the time of study enrollment.
Known uncontrolled abnormal coagulation status and are at additional risk for clotting or excessive bleeding.

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
DisTalTo create a DisTal arteriovenous fistula, the radial vein and radial artery are accessed percutaneously. Venous and arterial guidewires are inserted-with the arterial wire navigating from the vein into the artery-and aligned in position. The DisTal device, featuring a circular blade on a torque shaft, is advanced over both wires. As it advances, DisTal pulls the vessels together while the blade cuts a 7-10 mm opening between the adjoining artery and vein, establishing a non-surgical, endovascular arteriovenous fistula that allows direct blood flow.	Device	DisTal

Primary outcome

Percutaneous DisTal AVF vein enlargement success rate
Time frame: within 100 days of establishing DisTal AVF
Proportion of participants in whom the vein at the site of the DisTal AVF exhibits enlargement compared to the pre-procedural values, as confirmed by ultrasound.

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 25 Aug 2026.
Individual participant dataSharing planned: No

Related trials for End-Stage Renal Disease Requiring Haemodialysis

RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult
Recruiting
DIALysis With EXpanded Solute Removal
Chronic Kidney Disease Requiring Hemodialysis, End-Stage Kidney Disease (ESKD)
Not yet recruitingObservational study
Artificial Intelligence - Based Opportunistic Coronary Artery Calcium Scoring on Routine Chest-CT Scan
Coronary Artery Calcification, Cardiovascular Risk
RecruitingPhase 2
A Study to Evaluate Safety, Tolerability and Efficacy of AP306 at Fixed Doses in Dialysis Participants With Hyperphosphatemia
Hyperphosphatemia, Chronic Kidney Disease Requiring Chronic Dialysis
Recruiting
Incremental Hemodialysis for Veterans in the First Year of Dialysis (IncHVets)
Chronic Kidney Disease (CKD) Stage 5, Kidney Dysfunction Requiring Dialysis (KDRD)

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 DisTal in people with End-Stage Renal Disease Requiring Haemodialysis, run by Distal Inc. at 1 site in Dominican Republic.

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 4 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: under way, not looking for participants, as of the sponsor's last update on 25 Aug 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 Dominican Republic. 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?

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?

Percutaneous DisTal AVF vein enlargement success rate (time frame: within 100 days of establishing DisTal AVF). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07786025.

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 25 Aug 2026.