Trial Search Results

Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing

The purpose of this study is to study the safety and effectiveness of LifeSeal, a novel surgical sealant, to reduce the risk of leakage from the site of colon reconnection ("anastomosis") after surgery to remove diseased tissue. Post-operative colon leakage is a major complication of colorectal surgery. Study participants will be blinded to whether they receive standard surgery or surgery plus LifeSeal sealant. Participants have a 50% chance of receiving LifeSeal sealant.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

LifeBond Ltd.

Intervention(s):

  • Device: LifeSeal™ Kit

Phase:

Phase 3

Eligibility


Inclusion Criteria:

   1. Male or female ≥ 21 years of age at Screening Visit.

   2. Written informed consent obtained from subject or subject's legal representative and
   ability for subject to comply with the requirements of the study.

   3. Subject is diagnosed with colorectal cancer

   4. Subject is scheduled for elective open, laparoscopic or robot assisted surgery
   involving the creation of a circular stapled anastomosis created within 10cm from the
   anal verge.

   5. Procedure involving Total Mesorectal Excision by an abdominal or transanal approach.

   6. Female subjects in child bearing age must be using acceptable contraception methods
   such as hormonal contraception or two forms of barrier contraception. Acceptable
   contraception must be used consistently from 30 days before screening until 3 years
   following surgery

Exclusion Criteria:

Pre-operative exclusion criteria:

   1. Female subject who is pregnant, breastfeeding, or if of child bearing potential is
   unwilling to practice birth control until 3 years following surgery.

   2. Presence of a condition or abnormality that in the opinion of the Investigator would
   compromise the safety of the subject or the quality of the data.

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

   4. Subject has a history of hypersensitivity to microbial Transglutaminase.

   5. Subject has a known dysfibrinogenemia, hypofibrinogenemia or a fibrinogenemia, without
   preoperative correction of fibrinogen levels.

   6. Subject participating in any other study involving an investigational (unapproved)
   drug or device within the past 60 days.

   7. Subject participating in studies involving approved drug or device will be enrolled
   only following a mutual consideration of the investigator together with the Sponsor.

   8. Subject with a BMI ≥50, which may interfere with access to the surgical site and
   increase overall operative risk.

   9. Subject with American Society of Anesthesiology (ASA) status higher than 3.

10. Avastin use within 30 days prior to surgery.

11. Subject who has undergone a prior pelvic anastomosis.

12. Subject is scheduled for another surgery during the first 6 months following surgery
   (not including stoma closure ,placement of port for chemotherapy or ureter stent
   insertion).

13. Subject with an active abdominal or pelvic infection at the operation site.

14. Subject has been previously treated with LifeSeal™ Surgical Sealant.

Intra-operative Exclusion Criteria

   1. Anastomosis or procedure (TME) was performed differently from what was defined in the
   inclusion criteria.

   2. Subject received intra-operative sealant, glue or any buttressing material other than
   the LifeSeal™ Surgical Sealant.

   3. Subject has peritoneal carcinomatosis.

   4. Subject requires additional unrelated anastomosis during the surgery.

   5. Subject is going through another surgical procedure (other than ileostomy or
   adhesiolysis) during the surgery.

   6. Excessive bleeding (above 500cc) identified prior to anastomosis formation with the
   need for intra-operative blood transfusion.

   -

Ages Eligible for Study

21 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
CCTO
650-498-7061
Not Recruiting