Seal-V Safety and Performance Study

NCT01625481 | Completed Phase 1

• 1 other identifier: WP2-072-02
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

C.Surgical Procedure; Vascular (Peripheral)

Outcome Measures

Primary Outcomes (1)

• TTH, Time to Hemostasis

  Duration from the point at which circulation is restored to the graft/artery until bleeding ceases at the treatment site

  Perioperative; within 10 minutes after clamp release

Secondary Outcomes (3)

• Successful cessation of bleeding at a treatment site

  Perioperative; within 10 minutes after clamp release

• Intraoperative blood loss

  Perioperative

• Incidence of successful deployment of the Seal-V device

  Perioperative

Study Arms (1)

Seal-V

EXPERIMENTAL

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

Interventions

Seal-V DEVICE

Seal-V is applied adjunctively to cover the suture lines.

Also known as: SEAlantis Vascular WP2(A)

Seal-V

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Major intraoperative complications that require resuscitation or deviation from the planned surgical procedure
• Local infection at the operating field

Sponsors & Collaborators

• Sealantis Ltd.: lead

Study Sites (3)

Department of Vascular Surgery, Bnai-Zion Medical Center

Haifa, Israel

Location

Vascular Surgery Department, Rambam Health Care

Haifa, Israel

Location

Department of Vascular Surgery, Chaim Sheba Medical Center

Tel Litwinsky, 52621, Israel

Location

Study Officials

• Rina Lev, PhD

  Sealantis Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: June 21, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2013
• Study Completion: March 1, 2014
• Last Updated: May 28, 2014

Record last verified: 2014-05

Locations

IL (3)