Not a traditional drug phase: VasQ for End Stage Renal Disease
VasQ is an external support implant for arteriovenous fistulas created for dialysis access. This is a postmarket surveillance, prospective, multi-center, randomly assigned, controlled, open label trial enrolling 300 patients randomly assigned into two study arms: * Treatment arm: End to side fistula supported with VasQ * Control: Standard of care end to side fistula
Official registry: https://clinicaltrials.gov/study/NCT06516653 · Laminate Medical Technologies · enrollment listed as 300
What this phase means
This study does not use the classic phase 1–4 drug ladder. It may be a device, a behavior program, a surgery timing study, or an early feasibility test.
Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
What the registry says happens
If you join, the listed intervention(s) are VasQ, or Arteriovenous fistula creation for dialysis vascular access. The registry lists allocation as randomized. VasQ is an external support implant for arteriovenous fistulas created for dialysis access.
They plan to enroll about 300 people at 13 sites. Taking part typically means using or being fitted with a device, a procedure as part of the study plus check-ins.
Official title (unrewritten)
Postmarket Surveillance, Prospective, Multicenter, Randomized, Controlled Study Evaluating the Performance of VasQ for Its Intended Use.
Interventions: VasQ, Arteriovenous fistula creation for dialysis vascular access
Primary outcome (registry wording): Fistula functional success
Who it is for (from inclusion criteria)
- Ages 18 Years to 80 Years
- 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
- Patients willing and able (physically and geographically) to attend follow up visits over a period of 12 months
Who the registry excludes
- 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
- Pre-existing stents or stent grafts in the access circuit
- Planned subsequent fistula superficialization procedure
- Known coagulation disorder
Public study contact (from the registry)
Galit Itzhaki
Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.
Sites listed on ClinicalTrials.gov
13 listed- Fresenius Vascular Care Long Beach — Long Beach, California (recruiting)
- Sarasota Memorial Health Care System — Sarasota, Florida (recruiting)
- Grady Memorial Hospital — Atlanta, Georgia (recruiting)
- Atlanta VA Medical Center — Decatur, Georgia (recruiting)
- Ochsner Clinic Foundation — New Orleans, Louisiana (recruiting)
- Brigham and Women's Hospital — Boston, Massachusetts (recruiting)
- Greenwood Leflore Hospital — Greenwood, Mississippi (recruiting)
- Azura Surgery Center Las Vegas — Las Vegas, Nevada (active_not_recruiting)
- Fresenius Vascular Care Columbia — Columbia, South Carolina (recruiting)
- James E. Gardner MD, P.C. — Memphis, Tennessee (not_yet_recruiting)
- Vanderbilt University Medical Center — Nashville, Tennessee (recruiting)
- Houston Methodist Hospital — Houston, Texas (recruiting)
FAQ about this NCT record
Is NCT06516653 still recruiting?
The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.
What phase is NCT06516653?
Not a traditional drug phase. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.
Can PlainTrials tell me if I qualify for NCT06516653?
No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.
How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary