Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00479180

Enrollment

Registered

2007-05-28

Start date

2006-07-31

Completion date

2010-06-30

Last updated

2011-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hemodialysis Access

Keywords

Hemodialysis access, Arteriovenous graft, Arteriovenous fistula, End stage renal disease

Brief summary

Vascugel™ is safe when placed at the anastomotic site at the time of surgery during creation of an AV graft or fistula for hemodialysis access.

Detailed description

Randomized, double-blind, parallel group, Phase I/II clinical trial of Vascugel™ treatment vs. Gelfoam® in patients undergoing creation of an arteriovenous graft or fistula for hemodialysis access. All patients will undergo preoperative duplex ultrasound imaging and/or angiography (whatever is the standard of care at the research site) of the vein and artery to evaluate the optimal site for vascular access placement in the upper extremity. Patients will be examined with Doppler ultrasound or standard of care immediately after surgery to verify patency of the AV graft or fistula. During the follow-up period, each patient will undergo a physical examination and imaging of the vascular access at specified intervals.

Interventions

BIOLOGICALVascugel

One time implant on the day of surgery

BIOLOGICALPlacebo Comparator

One time implant on the day of surgery

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 89 Years

Healthy volunteers

Inclusion criteria

* Adult male or female patients (ages of 18 to 89, inclusive) who are undergoing placement of an AV graft or fistula for hemodialysis access

Exclusion criteria

* Patient is currently on an active transplant list for a kidney from a deceased donor OR is undergoing assessment and expects to be placed on the active transplant list within the next twenty-four weeks OR expects to receive a living donor kidney within twenty-four weeks. * Patient is expecting another solid organ transplant or a bone marrow transplant. * Patient has had more than one access surgery (defined as a new access, not a revision) in the target limb. * Patient is currently on chronic, systemic immunosuppressant medication other than locally or topically applied steroids.

Design outcomes

Primary

Measure	Time frame
Safety of vascugel	6 months followed by 2.5 year extension

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026