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NCT07786025Active, not recruiting

DisTal Arterio-Venous Fistula Feasibility

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

Source: ClinicalTrials.gov · Last updated 25 Aug 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
100 (actual)
First submitted
21 Aug 2026
Start date
2 Dec 2024
Primary completion date
1 Mar 2027
Lead sponsor
Distal Inc.
NCT number
NCT07786025

What you commit to

  • Study type: Interventional
  • Participants enrolled: 100
  • From 2 Dec 2024 to the primary completion date, 1 Mar 2027
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Prior surgically created access in the planned treatment location.

Other illness

  • 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.

Other

  • Pregnancy or lactation.
  • Known central venous stenosis on the same side as the planned AVF creation.
  • Prisoner.
  • Employee of the Sponsor.

Who the study is looking for

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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Clinica Canela
Coordinator of this site? Confirm its status
La RomanaDominican RepublicUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.