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Active Not Recruiting
NCT07786025
DisTal Arterio-Venous Fistula Feasibility
Conditions: End-Stage Renal Disease Requiring Haemodialysis
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 100
Sponsor: Distal Inc.
Location: Clinica Canela La Romana
Summary
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.
Eligibility Criteria
Inclusion Criteria:
1. Age ≥ 18.
2. End Stage Renal Disease (ESRD) requiring hemodialysis.
3. Having a patent cephalic vein at the wrist /forearm.
4. Signed informed consent.
Exclusion Criteria:
1. Pregnancy or lactation.
2. Known central venous stenosis on the same side as the planned AVF creation.
3. Prior surgically created access in the planned treatment location.
4. Evidence of active infections at the time of study enrollment.
5. Known uncontrolled abnormal coagulation status and are at additional risk for clotting or excessive bleeding.
6. Prisoner.
7. Employee of the Sponsor.
Source: ClinicalTrials.gov (NCT07786025). StuddyBuddy aggregates publicly available trial information.
