LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge

LifeBond

Status

Completed

Conditions

Rectal Cancer

Treatments

Device: LifeSeal™ Kit

Study type

Interventional

Funder types

Industry

Identifiers

CLP-LS-0110

Details and patient eligibility

About

A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.

Enrollment

70 patients

Sex

All

Ages

18 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject, or authorized representative, signed a written Informed Consent Form
Subject is 18 years or older
Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
If female - not be of child bearing potential, or be using acceptable contraception methods.
Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.

Exclusion criteria

Subject has a history of hypersensitivity to porcine derived gelatin or collagen
Subject participating in any other study involving an investigational (unapproved) drug or device.
Subject with a BMI higher than 40
Female Subject states that she is pregnant or breast feeding
Subject with ASA status higher than 3
Avastin use within 30 days prior to surgery
Subject who underwent a prior pelvic anastomosis
Subject is scheduled for another surgery during the follow up period of this study (not including stoma closure)