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A Prospective Randomized Single Blinded Study of Continuous Suturing Versus Interrupted Clips for Brachiocephalic AV Fistula Creation (NCT03024372)

The purpose of this study is to investigate a promising strategy to improve maturation and patency rates following creation of AV fistulas and assess whether an anastomosis performed with Anastoclips (interrupted, nonpenetrating) would produce better maturation and/or patency than one performed with conventional suturing techniques.
  • Device: AV Fistula creation with sutures
    End-to-side anastomosis (of AV fistula) is to be constructed using sutures. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.
    • Device: AV Fistula creation with clips
      End-to-side anastomosis (of AV fistula) is to be constructed using clips. The incision is to be irrigated and closed using Vicryl, Biosyn and skin glue.
      Ages eligible for Study
      18 Years and older
      Genders eligible for Study
      All
      Accepts Healthy Volunteers
      No
      Inclusion Criteria:
      • Requiring brachiocephalic fistula judged to be best option for access after vein mapping (Surgeons will be required to do 10 cases using Anastoclips prior to enrolling)
      • Able to provide informed consent in English or Spanish
      • Age 18 years or greater
      • With estimated life expectancy of 2 years or more
      • Able to comply with study procedures including all scheduled follow-up visits
      Exclusion Criteria:
      • Unable to provide informed consent in English or Spanish
      • Age < 18 years
      • With pacemaker, IACD, or other permanent obstructive device on that side (a temporary tunneled dialysis catheter is not an exclusion)
      • Unable (or in surgeon's judgment a poor risk) to comply with study procedures and follow-up visits
      • With estimated life expectancy of less than 2 years
      • Females must be either:
      • Of non-childbearing potential, which is defined as post-menopausal (at least 12 months without menses prior to Treatment Day) or documented surgically sterile or post hysterectomy (at least 1 month prior to Treatment Day)
      • Or, of childbearing potential, in which case must have a negative urine pregnancy test at Treatment Day
      This will be a single blind (patient and dialysis center), prospective, randomized trial conducted at a single center. The study intervention will be randomization between conventional sutured anastomosis (Control group) and use of Anastoclips (Treatment group), which provide an interrupted closure without intimal penetration.

      3 locations

      United States (3)
      • Tampa General Hospital
        recruiting
        Tampa, Florida, United States, 33606
      • University of South Florida - South Tampa Campus
        recruiting
        Tampa, Florida, United States, 33606
      • USF Health Carol and Frank Morsani Center for Advanced Healthcare
        recruiting
        Tampa, Florida, United States, 33612
      Status:
      recruiting
      Type:
      Interventional
      Phase:
      -
      Start:
      31 January, 2017
      Updated:
      15 February, 2017
      Participants:
      164
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