Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT05846581 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

Registry of GORE® ACUSEAL Vascular Graft in Dialysis Access

Study acronym: AVG22-09
StatusRecruiting
PhaseNot specified
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Study sites: 5 to 4v12
  2. Re-verified, no change to tracked fieldsv11
  3. Site details revised at 1 of 5 sitesv10
  4. Site contacts updated at 1 of 5 sitesv9
  5. Start date changed from estimate of Feb 2024 to Jan 12, 2024v8
Show 6 earlier versionsHide 6 earlier versions
  1. Start date: Dec 2023 to Feb 2024v7
  2. Site details revised at 1 of 5 sitesv6
  3. Start date: Oct 27, 2023 to Dec 2023
    • Secondary endpoints: details revised at 1 of 4 entries
    • Site details revised at 1 of 5 sites
    v5
  4. Trial status: Not Yet Recruiting to Recruiting
    • Primary and study completion dates: Sep 30, 2027 to Oct 27, 2027
    • Start date: Nov 30, 2023 to Oct 27, 2023
    • Site details revised at 5 of 5 sites
    v4
  5. Start date: Oct 1, 2023 to Nov 30, 2023v3
  6. Primary endpoints revised (2)
    • Study sites: 4 to 5
    • Secondary endpoints revised (4)
    v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
The goal of this observational study is to evaluate safety and performance of GORE® ACUSEAL Vascular Graft for the treatment of CKD in patients with ESRD in hemodialysis. The main questions it aims to answer are: * Safety: Freedom from device-related infection adverse events at 24 months from device implant * Performance: Secondary patency at 24 months from device implant. Participants, after informed consent is obtained, will be implanted with GORE® ACUSEAL Vascular Graft and followed for 24 months in standard of care, to evaluate safety and performance of the device.
Trial Details
NCT Number NCT05846581
Lead Sponsor W.L.Gore & Associates
Conditions
(from sponsor)		 Chronic Kidney Diseases, End Stage Renal Disease on Dialysis
Related terms Kidney Failure, Chronic, Renal Insufficiency, Chronic
Enrollment 72 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov