Clinical trial NCT01625481: Seal-V Safety and Performance Study
Official title: Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: C.Surgical Procedure; Vascular (Peripheral)
Lead sponsor: Sealantis Ltd.
Sponsor class: INDUSTRY
First posted: 2012-06-21
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: TTH, Time to Hemostasis
timeFrame: Perioperative; within 10 minutes after clamp release
Secondary outcomes:
measure: Successful cessation of bleeding at a treatment site
timeFrame: Perioperative; within 10 minutes after clamp release
measure: Intraoperative blood loss
timeFrame: Perioperative
measure: Incidence of successful deployment of the Seal-V device
timeFrame: Perioperative
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Department of Vascular Surgery, Bnai-Zion Medical Center
city: Haifa
country: Israel
facility: Vascular Surgery Department, Rambam Health Care
city: Tel Hashomer
country: Israel
facility: Department of Vascular Surgery, Chaim Sheba Medical Center
Study officials:
affiliation: Sealantis Ltd.
name: Rina Lev, PhD
role: STUDY_DIRECTOR
References: