Recruiting

VasQ Device for Arteriovenous Fistula Performance

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Study Aim

This study aims to assess the performance of the VasQ device in preventing complications and ensuring the successful use of arteriovenous fistulas for dialysis in patients.

What is being tested

VasQ

+ Arteriovenous fistula creation for dialysis vascular access

DeviceProcedure
Who is being recruted

Urogenital Diseases+10

+ Chronic Disease

+ Female Urogenital Diseases and Pregnancy Complications

From 18 to 80 Years
+16 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Prevention Study

Interventional
Study Start: January 2025
See protocol details

Summary

Principal SponsorLaminate Medical Technologies
Study ContactGalit Itzhaki
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: January 13, 2025

Actual date on which the first participant was enrolled.

This study aims to evaluate the effectiveness of a medical device called VasQ in patients who need a type of vascular access known as an arteriovenous fistula (AVF), which is used for treatments like dialysis. It targets adults who require this procedure. The goal is to see if VasQ can help the fistula become fully functional more quickly compared to the usual method without the device. Understanding the benefits of VasQ could lead to better care for patients undergoing this procedure and potentially improve their overall treatment experience. Participants in this study will be randomly assigned to one of two groups. One group will receive the AVF procedure supported with the VasQ device, while the other group will receive the standard procedure without VasQ. The study will track how long it takes for the fistula to become fully functional in each group, with initial results assessed six months after the procedure, and additional follow-ups continuing up to 12 months. This approach ensures any differences in outcomes between the two groups can be clearly understood, helping to determine the true benefit of using VasQ.

Official TitlePostmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.
NCT06516653
Principal SponsorLaminate Medical Technologies
Study ContactGalit Itzhaki
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

300 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Prevention Study

Prevention studies aim to stop a disease from developing. They often involve people at risk and test things like vaccines, lifestyle changes, or preventive medications.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Urogenital DiseasesChronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesKidney Failure, ChronicPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

4 inclusion criteria required to participate
Patients who are candidates for the creation of a new radiocephalic or brachiocephalic end-to-side surgical AV fistula for dialysis access (per VasQ IFU and investigator clinical judgment) and consent to take part in the study.
Male and non-pregnant female participants.
Age 18-80 years
Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months.
12 exclusion criteria prevent from participating
Index procedure being a revision surgery of an existing fistula.
Significantly stenotic target vein on the side of surgery (≥50%) as diagnosed on preoperative ultrasound. (Scan should include the full length of the expected fistula outflow, starting at the planned anastomosis site)
Unusual anatomy or vessel dimensions (observed on pre-operative ultrasound or intraoperatively) and which preclude adequate fit of the VasQ.
Known central venous stenosis or obstruction on the side of surgery.
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access

Group II

Active Comparator
Patients receiving an end to side arteriovenous fistula, for fistula access

Study Objectives

Primary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 7 locations

Recruiting

Fresenius Vascular Care Long Beach

Long Beach, United StatesOpen Fresenius Vascular Care Long Beach in Google Maps
Recruiting

Sarasota Memorial Hospital

Sarasota, United States
Recruiting

Brigham and Women's Hospital

Boston, United States
Recruiting

Greenwood Leflore Hospital

Greenwood, United States
Recruiting
7 Study Centers