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

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ClinicalTrials.gov Identifier: NCT00479180
Recruitment Status : Completed
First Posted : May 28, 2007
Last Update Posted : October 27, 2011
Sponsor:
Information provided by:
Pervasis Therapeutics, Inc

Tracking Information
First Submitted Date  ICMJE May 24, 2007
First Posted Date  ICMJE May 28, 2007
Last Update Posted Date October 27, 2011
Study Start Date  ICMJE July 2006
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 21, 2007)
Safety of vascugel [ Time Frame: 6 months followed by 2.5 year extension ]
Original Primary Outcome Measures  ICMJE
 (submitted: May 25, 2007)
To evaluate the safety of Vascugel™ treatment in patients undergoing creation of an AV graft or fistula for hemodialysis access [ Time Frame: Within the first 30 days ]
Change History Complete list of historical versions of study NCT00479180 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
Official Title  ICMJE Safety of Vascugel Treatment After Creation of Arteriovenous Access for Hemodialysis Use
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Hemodialysis Access
Intervention  ICMJE
  • Biological: Vascugel
    One time implant on the day of surgery
  • Biological: Placebo Comparator
    One time implant on the day of surgery
Study Arms  ICMJE
  • Experimental: AVG1
    Vascugel
    Intervention: Biological: Vascugel
  • Placebo Comparator: AVG2
    Gelfoam
    Intervention: Biological: Placebo Comparator
  • Experimental: AVF3
    Vascugel
    Intervention: Biological: Vascugel
  • Placebo Comparator: AVF4
    Gelfoam
    Intervention: Biological: Placebo Comparator
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2011)
65
Original Estimated Enrollment  ICMJE
 (submitted: May 25, 2007)
64
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 89 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00479180
Other Study ID Numbers  ICMJE PVS-06-003/06-004
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Elizabeth Merica, Director,Clinical Affairs, Pervasis Therapeutics
Study Sponsor  ICMJE Pervasis Therapeutics, Inc
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Pervasis Therapeutics, Inc
Verification Date October 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP