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CompletedNCT00479180Updated Oct 27, 2011

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

A Phase 1/2 interventional study of Vascugel and Placebo Comparator in Hemodialysis Access, sponsored by Pervasis Therapeutics, Inc. Completed at 1 site in United States. Open to participants aged 18 Years to 89 Years. Per ClinicalTrials.gov, last updated 2011-10-27.

Sponsored by Pervasis Therapeutics, Inc · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
65
Allocation
Randomized
Ages
18 Years to 89 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Hemodialysis Access

Keywords

  • Hemodialysis access
  • Arteriovenous graft
  • Arteriovenous fistula
  • End stage renal disease
03

In context

Lead sponsor

This is the only study on the registry with Pervasis Therapeutics, Inc as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 89 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
65 participants (actual)

Study arms

  • Experimental
    AVG1

    Vascugel

    Biological: Vascugel

  • Placebo comparator
    AVG2

    Gelfoam

    Biological: Placebo Comparator

  • Experimental
    AVF3

    Vascugel

    Biological: Vascugel

  • Placebo comparator
    AVF4

    Gelfoam

    Biological: Placebo Comparator

Interventions

  • BiologicalVascugel

    One time implant on the day of surgery

  • BiologicalPlacebo Comparator

    One time implant on the day of surgery

06

What researchers measure

Primary outcomes

  1. Safety of vascugel

    Time frame: 6 months followed by 2.5 year extension

07

Study locations

1 site
  • Brigham and Women's Hospital
    Boston, Massachusetts 02115, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2011, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00479180
Lead sponsor
Pervasis Therapeutics, Inc
First posted
May 28, 2007
Start date
Jul 2006
Primary completion
Jun 2010
Completion
Jun 2010
Last update
Oct 27, 2011

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2011. You cannot join it, but the record below documents what was studied.

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