Clinical Trial: SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational [Patient Registry]
Official Title: SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoi
Brief Summary: This study will assess the effectiveness of commercially available LifeSeal® Kit as measured by the incidence of post-operative clinical anastomotic leak rates in subjects undergoing low and ultralow anterior resection with an anastomosis. All patients treated with LifeSeal® will be offered to participate
Detailed Summary: The LifeSeal® Kit is a novel surgical sealant intended to be used as an adjunct to suture or staple line during standard surgical repair of the GI tract (anastomosis or linear) to provide re-inforcement and help reduce leaks. The LifeSeal™ Kit has recently been CE certified on March 2016 for marketing in the European Union.
Sponsor: LifeBond Ltd.
Current Primary Outcome: Incidence of post-operative clinical anastomotic leaks at discharge [ Time Frame: discharge from hospital 3-14 days post surgery ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery [ Time Frame: up to 4 weeks post surgery ]
Original Secondary Outcome: Same as current
Information By: LifeBond Ltd.
Dates:
Date Received: August 23, 2016
Date Started: October 2016
Date Completion:
Last Updated: November 20, 2016
Last Verified: November 2016