Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.

Status: Recruiting
Location: See all (3) locations...
Intervention Type: Procedure, Device
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomized, controlled, open label trial enrolling 300 patients randomized into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
United States
Florida
Sarasota Memorial Hospital
RECRUITING
Sarasota
Mississippi
Greenwood Leflore Hospital
RECRUITING
Greenwood
Virginia
Fairlawn Surgery Center
RECRUITING
Roanoke
Contact Information
Primary
Galit Itzhaki
galit@laminatemedical.com
+972-3-6344246
Time Frame
Start Date: 2025-01-13
Estimated Completion Date: 2028-05
Participants
Target number of participants: 300
Treatments
Experimental: End to side fistula supported with VasQ
Patients receiving an end to side arteriovenous fistula, supported by VasQ, for fistula access
Active_comparator: Standard of care end to side fistula
Patients receiving an end to side arteriovenous fistula, for fistula access
Sponsors
Leads: Laminate Medical Technologies

This content was sourced from clinicaltrials.gov