Seal-V Safety and Performance Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Sealantis Ltd.
ClinicalTrials.gov Identifier:
NCT01625481
First received: June 19, 2012
Last updated: May 26, 2014
Last verified: May 2014
  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
C.Surgical Procedure; Vascular (Peripheral)
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 ]

Enrollment: 23
Study Start Date: July 2012
Study Completion Date: March 2014
Primary Completion Date: December 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 requiring vascular reconstruction surgeries using synthetic (such as PTFE, Dacron) or autologous (such as native veins) grafts, including the following:
  • Peripheral bypass surgeries, such as arterio-arterial bypasses [including: axillo-(bi)femoral, ilio-(bi)femoral, femoro-femoral, ilio-popliteal, femoro-popliteal (including below knee), femoro-tibial vessel bypass]
  • Arteriovenous (AV) dialysis access shunt in the upper or lower extremity
  • Patients able and willing to complete all follow-up visits

Exclusion Criteria:

  • Vascular surgery other than peripheral bypass surgeries and arteriovenous (AV) dialysis access shunt procedures as described above
  • 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 [<100,000 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01625481

Locations
Israel
Department of Vascular Surgery, Bnai-Zion Medical Center
Haifa, Israel
Vascular Surgery Department, Rambam Health Care
Haifa, Israel
Department of Vascular Surgery, Chaim Sheba Medical Center
Tel Hashomer, Israel, 52621
Sponsors and Collaborators
Sealantis Ltd.
Investigators
Study Director: Rina Lev, PhD 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: May 26, 2014
Health Authority: Israel: Israeli Health Ministry Pharmaceutical Administration

ClinicalTrials.gov processed this record on October 23, 2014