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

NCT ID: NCT00479180

Last Updated: 2011-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-07-31

Study Completion Date

2010-06-30

Brief Summary

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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

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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.

Conditions

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Hemodialysis Access

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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AVG1

Vascugel

Group Type EXPERIMENTAL

Vascugel

Intervention Type BIOLOGICAL

One time implant on the day of surgery

AVG2

Gelfoam

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type BIOLOGICAL

One time implant on the day of surgery

AVF3

Vascugel

Group Type EXPERIMENTAL

Vascugel

Intervention Type BIOLOGICAL

One time implant on the day of surgery

AVF4

Gelfoam

Group Type PLACEBO_COMPARATOR

Placebo Comparator

Intervention Type BIOLOGICAL

One time implant on the day of surgery

Interventions

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Vascugel

One time implant on the day of surgery

Intervention Type BIOLOGICAL

Placebo Comparator

One time implant on the day of surgery

Intervention Type BIOLOGICAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

89 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Pervasis Therapeutics, Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Pervasis Therapeutics

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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PVS-06-003/06-004

Identifier Type: -

Identifier Source: org_study_id