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Seal-V Safety and Performance Study

This study is currently recruiting participants.
Verified November 2012 by Sealantis Ltd.
Sponsor:
Information provided by (Responsible Party):
Sealantis Ltd.
ClinicalTrials.gov Identifier:
NCT01625481
First received: June 19, 2012
Last updated: November 7, 2012
Last verified: November 2012
History of Changes
  Purpose

The purpose of this study is to further assess the safety and performance of Seal-V as an adjunct to standard surgical procedure for achieving hemostasis in patients undergoing peripheral vascular reconstruction surgeries using synthetic grafts.


Condition Intervention Phase
Peripheral Vascular Bypass Procedures
Hemodialysis Access
 Device: Seal-V
 Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System

Further study details as provided by Sealantis Ltd.:

Primary Outcome Measures:
  • TTH, Time to Hemostasis [ Time Frame: Perioperative; within 10 minutes after clamp release ] [ Designated as safety issue: Yes ]
    Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site


Secondary Outcome Measures:
  • Successful cessation of bleeding at a treatment site [ Time Frame: Perioperative; within 10 minutes after clamp release ] [ Designated as safety issue: Yes ]
  • Intraoperative blood loss [ Time Frame: Perioperative ] [ Designated as safety issue: Yes ]
    Measured by weighing the surgical swabs used only in the application area and used from the time Seal-V was applied until hemostasis

  • Incidence of successful deployment of the Seal-V device [ Time Frame: Perioperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 23
Study Start Date: July 2012
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Seal-V
A vascular sealant intended to achieve adjunctive hemostasis by mechanically sealing areas of potential leakage in surgical reconstruction of large blood vessels.
 Device: Seal-V
Seal-V is applied adjunctively to cover the suture lines.
Other Name: SEAlantis Vascular WP2(A)

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female of > 18 years of age
  • Signed Informed Consent
  • Patients undergoing following procedures:
  • Hemodialysis AV access procedures
  • Bypass/Abdominal Aortic Aneurysm, including but not limited to femoropopliteal, femorodistal, femorofemoral, aortofemoral, iliofemoral or axillofemoral bypass
  • Endarterectomy & patch
  • Patients able and willing to complete all follow-up visits

Exclusion Criteria:

  • Reoperation at the same treatment site
  • Known sensitivity to device materials, such as indigo carmine dye or alginate
  • Pregnant or lactating women
  • Systemic infection
  • Participation in another clinical trial or treatment with any investigational agent in past 30 days
  • Congenital coagulation disorders (e.g., thrombocytopenia [< 80,000 platelet count], thromboasthenia, hemophilia, or von Willebrand disease)
  • Severe congenital or acquired immunodeficiency (e.g., HIV infection or long term treatment with immunosuppressive drugs)
  • Prior radiation therapy to the operating field

Intraoperative Exclusion Criteria:

  • Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
  • Intraoperative change in planned surgical procedure that results in the patient no longer meeting preoperative inclusion and/or exclusion criteria
  • Local infection at the operating field
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01625481

Contacts
Contact: Rina Lev, PhD 972-4-829 1033 RinaL@trdf.technion.ac.il

Locations
Israel
Department of Vascular Surgery, Bnai-Zion Medical Center Recruiting
Haifa, Israel
Contact: Zeev Loberman, MD     972-4-8359137     zeev.loberman@gmail.com    
Principal Investigator: Zeev Loberman, MD            
Sponsors and Collaborators
Sealantis Ltd.
  More Information

No publications provided

Responsible Party: Sealantis Ltd.
ClinicalTrials.gov Identifier: NCT01625481     History of Changes
Other Study ID Numbers: WP2-072-02
Study First Received: June 19, 2012
Last Updated: November 7, 2012
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on June 18, 2013