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Seal-V Safety and Performance Study

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01625481
First Posted: June 21, 2012
Last Update Posted: May 28, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Sealantis Ltd.
June 19, 2012
June 21, 2012
May 28, 2014
July 2012
December 2013   (Final data collection date for primary outcome measure)
TTH, Time to Hemostasis [ Time Frame: Perioperative; within 10 minutes after clamp release ]
Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site
TTH, Time to Hemostasis [ Time Frame: Perioperative. After the device application at the treatment site to the achievement of hemostasis at that site and clamp release, or to the end of the 10 minute observational period when the hemostasis has not yet been achieved ]
Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site
Complete list of historical versions of study NCT01625481 on ClinicalTrials.gov Archive Site
  • Successful cessation of bleeding at a treatment site [ Time Frame: Perioperative; within 10 minutes after clamp release ]
  • Intraoperative blood loss [ Time Frame: Perioperative ]
    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 ]
  • Successful cessation of bleeding at a treatment site [ Time Frame: Perioperative. Within 10 minutes after clamp release ]
  • Intraoperative blood loss [ Time Frame: Perioperative. Within 10 minutes after clamp release ]
    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 ]
Not Provided
Not Provided
 
Seal-V Safety and Performance Study
Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System
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.
Not Provided
Interventional
Phase 1
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
C.Surgical Procedure; Vascular (Peripheral)
Device: Seal-V
Seal-V is applied adjunctively to cover the suture lines.
Other Name: SEAlantis Vascular WP2(A)
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.
Intervention: Device: Seal-V
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
23
March 2014
December 2013   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
 
NCT01625481
WP2-072-02
No
Not Provided
Not Provided
Sealantis Ltd.
Sealantis Ltd.
Not Provided
Study Director: Rina Lev, PhD Sealantis Ltd.
Sealantis Ltd.
May 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP