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

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

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

Inclusion Criteria:

1. Subject, or authorized representative, signed a written Informed Consent Form
2. Subject is 18 years or older
3. Subject is scheduled for elective open or laparoscopic surgery involving the creation of a circular stapled anastomosis created within 10cm from the anal verge.
4. If female - not be of child bearing potential, or be using acceptable contraception methods.
5. 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:

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