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NCT00618358 · ClinicalTrials.gov registry record · Phase 1
Vascular Sealant Study
A Phase 1 study, sponsored by Georgetown University.
- Terminated
- Registry status
- Phase 1
- Development phase
NCT00618358 is a Phase 1 study that was terminated before completion, run by Georgetown University.
The verdict
NCT00618358, a Phase 1 study, was terminated before completion, sponsored by Georgetown University.
- TERMINATED
- Registry status
- Phase 1
- Development phase
Study Summary
Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including extra-anatomic, infrainguinal bypass and arteriovenous (AV) access procedures). Study Design: The study is a multi-center, prospective, randomized controlled clinical trial that will compare two methods for treating anastomotic leakage (bleeding). All subjects (n =151) will be randomized at a 3:1 ratio to receive either the investigational treatment (Vascular Sealant) or the control treatment (Gelfoam/Thrombin). Up to two (2) treatment sites may be evaluated for each subject. Subjects will be stratified by type of graft procedure: AV access graft or extra-anatomic and infra-inguinal graft. A minimum of 60 patients, and a maximum of 91 patients, will be enrolled in each stratum. Treatment randomization will be blocked by center and type of graft procedure (e.g., bypass or AV grafts). All subjects will undergo preoperative screening to determine eligibility and will be evaluated intraoperatively, at discharge or within 7 days of surgery, and 30 days post-procedure to monitor for hematologic disturbances, hemorrhagic events, wound complications and other potential acute post-operative adverse events. Up to ten (10) investigational sites will participate in the study. Enrollment is expected to take approximately 8 months for an anticipated duration of the clinical investigation of approximately 9 to 10 months. The primary objective of this trial is to demonstrate non-inferiority of the Vascular Sealant to Gelfoam/Thrombin when used to seal anastomotic suture lines in patients undergoing placement of PTFE vascular grafts (including extra-anatomic, infrainguinal bypass and arteriovenous access procedures).
Interventions
- DEVICE Vascular Sealant System
- OTHER Gelfoam/Thrombin
Trial Details
| Field | Value |
|---|---|
| Start Date | 2007-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00618358
The ClinicalTrials.gov registry entry for NCT00618358 describes a study currently listed as terminated, categorized as Phase 1. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is Georgetown University, which has 227 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Vascular Sealant System is the first listed.
NCT00618358 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00618358 about?
NCT00618358 is a clinical study titled "Vascular Sealant Study". Study Objective:To evaluate the safety and effectiveness of the Vascular Sealant compared with Gelfoam/Thrombin when used to seal bleeding anastomotic suture lines in patients undergoing vascular reconstructive surgery requiring placement of a PTFE graft (including extra-anatomic, infrainguinal bypa...
What is the current status of trial NCT00618358?
This trial is currently terminated. It is a Phase 1 study. The study started on 2007-03.
What interventions are being tested in trial NCT00618358?
The interventions under investigation include: Vascular Sealant System (DEVICE), Gelfoam/Thrombin (OTHER).
Who is sponsoring clinical trial NCT00618358?
This trial is sponsored by Georgetown University, which has 227 total clinical trials registered on ClinicalTrials.gov.
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