C.Surgical Procedure; Vascular (Peripheral) Clinical Trial
Official title:
Prospective, Single Arm, Open Label, Non-randomized Study to Evaluate The Safety and Performance of The Seal-V System
| Verified date | May 2014 |
| Source | Sealantis Ltd. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | Israel: Israeli Health Ministry Pharmaceutical Administration |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 23 |
| Est. completion date | March 2014 |
| Est. primary completion date | December 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Sealantis Ltd. |
Israel,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | Yes |
| Secondary | Successful cessation of bleeding at a treatment site | Perioperative; within 10 minutes after clamp release | Yes | |
| Secondary | Intraoperative blood loss | Measured by weighing the surgical swabs used only in the application area and used from the time Seal-V was applied until hemostasis | Perioperative | Yes |
| Secondary | Incidence of successful deployment of the Seal-V device | Perioperative | No |