SEAL Registry - European Registry for the Effectiveness of LifeSeal® Kit

LifeBond

Status: Unknown

Conditions: Anastomotic Leakage

Treatments: Device: LifeSeal® Kit

Study type: Observational

Funder types: Industry

Identifiers

NCT02881359

CLP-LS-0146

Details and patient eligibility

About

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

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. ≥ 18 years of age at screening visit
2. Written informed consent obtained
3. Subject is scheduled to have or already underwent elective open, laparoscopic or robot assisted surgery involving the creation of a coloanal or colorectal anastomosis* created within 15 cm from the anal verge.
4. Subject was already treated or is scheduled to be treated with LifeSeal® Kit, applied according to the IFU

Exclusion criteria

1. Subject with American Society of Anesthesiology (ASA) status > 3.

Trial design

200 participants in 1 patient group

LifeSeal® Kit

Description:

creation of a coloanal or colorectal anastomosis

Treatment:

Device: LifeSeal® Kit