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Seal-V Safety and Performance Study

NCT01625481 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2014-05-28

No results posted yet for this study

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)

Interventions

DEVICE

Seal-V

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

Sponsors & Collaborators

  • Sealantis Ltd.

    lead INDUSTRY

Principal Investigators

  • Rina Lev, PhD · Sealantis Ltd.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2013-12-31
Completion
2014-03-31

Countries

  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01625481 on ClinicalTrials.gov