Seal-V Safety and Performance Study

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Sealantis Ltd.
ClinicalTrials.gov Identifier:
NCT01625481
First received: June 19, 2012
Last updated: October 14, 2013
Last verified: October 2013

June 19, 2012
October 14, 2013
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 ] [ 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
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 ] [ 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
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 ] [ 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 ]
  • 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. Within 10 minutes after clamp release ] [ 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 ]
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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.
 
Active, not recruiting
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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Israel
 
NCT01625481
WP2-072-02
No
Sealantis Ltd.
Sealantis Ltd.
Not Provided
Study Director: Rina Lev, PhD Sealantis Ltd.
Sealantis Ltd.
October 2013

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