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

Anastomotic Leakage Clinical Trial

Official title:

SEAL Registry - Observational, Retrospective and Prospective, One Arm, Registry Study for the Effectiveness of LifeSeal® Kit on Anastomotic Leaks in Patients Undergoing Low and Ultralow Anterior Resection

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02881359
• Other study ID #: CLP-LS-0146
• Status: Active, not recruiting
• First received: August 23, 2016
• Last updated: March 29, 2018
• Start date: October 2016
• Est. completion date: September 2018

Study information

• Verified date: March 2018
• Source: LifeBond Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: September 2018
• Est. primary completion date: August 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Anastomotic Leakage

Intervention

Device:
• LifeSeal® Kit
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.

Locations

Country	Name	City	State
Belgium	Algemeen Stedelijk Ziekenhuis	Aalst
Belgium	ZNA Antwerpen Campus	Antwerpen
Belgium	Jessa Ziekenhuis	Hasselt
Belgium	Jan Yperman Ziekenhuis	Ieper
Belgium	CHR de la Citadelle	Liege
Belgium	H. Hartziekenhuis	Mol
Belgium	AZ Delta	Roeselare
Netherlands	ZGT	Almelo

Sponsors (1)

Lead Sponsor	Collaborator
LifeBond Ltd.

Countries where clinical trial is conducted

Belgium,  Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of post-operative clinical anastomotic leaks at discharge		discharge from hospital 3-14 days post surgery
Secondary	Incidence of post-operative clinical anastomotic leaks up to 4 weeks post-surgery		up to 4 weeks post surgery