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LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

18 Years
Open (Enrolling)
Rectal Cancer

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Trial Information

LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

Inclusion Criteria:

1. Subject, or authorized representative, signed a written Informed Consent

2. Subject is at least 18 years of age

3. Subject is scheduled for elective open resection

4. Stapled anastomosis created within 10cm of the anal verge

5. Subject is willing to comply with the follow-up requirements of the study

Exclusion Criteria:

1. Subject has a history of hypersensitivity to porcine derived gelatin or collagen

2. Subject has unacceptable baseline hematological results

3. Subject on chronic preoperative treatment with steroids and anticoagulants

4. Subject with elevated liver function tests

5. Subject with abnormal kidney function

6. Subject with a BMI higher than 35

7. Subject participating in any other study for either drug or device which can
influence collection of valid data under this study

8. Subject with a history of MI, CVA or ASA status IV or a life expectancy of less than
1 year

9. Anastomosis was performed differently from what was defined

10. Subject received intraoperative sealant, glue or any buttressing material for the
study related anastomosis, other than the LifeSeal™

11. Subject has intraoperative bleeding in excess of 500cc

12. Subject has peritoneal carcinomatosis

Type of Study:


Study Design:

Masking: Open Label

Outcome Measure:

Assessment of subject's safety by incidence of related Adverse Events

Outcome Time Frame:

Approx. 1 month

Safety Issue:



Sweden: Medical Products Agency

Study ID:




Start Date:

January 2013

Completion Date:

Related Keywords:

  • Rectal Cancer
  • Rectal Neoplasms