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

This study is currently recruiting participants.
Verified June 2017 by LifeBond Ltd.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907385
First Posted: September 20, 2016
Last Update Posted: June 6, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
LifeBond Ltd.
  Purpose

LifeSeal™ Kit, surgical sealant designed for staple-line reinforcement that is applied over the anastomotic line to prevent bowel content leakage until full physiological function is restored.

RATIONALE : Postoperative anastomotic leakage is one of the most devastating and feared complications in colorectal surgery. The risk of postoperative anastomotic leakage varies widely depending on the level of anastomosis while the risk is higher in low anastomosis.

In order to best demonstrate the benefits of LifeSeal™ in providing staple line reinforcement and helping to reduce leaks, the study includes high risk anastomoses, defined as colorectal and coloanal anastomoses performed within 10 cm from the anal verge.

STUDY DESIGN: This study is designed as a prospective, multi-center, multinational randomized, single-blind, double armed study PRIMARY OBJECTIVE: The primary objective of this study is to assess the efficacy and safety of LifeSeal™ Kit as measured by the change in overall anastomotic leak rates in subjects undergoing low anterior resection with an anastomosis below 10 cm from the anal verge, over the first 17 weeks after surgery.

SECONDARY OBJECTIVES: The secondary objective of this study is to assess the incidence of post-operative leaks and additional benefits that could be related to the use of LifeSeal™ Kit such as reducing the severity and improving the outcome of a leak once it has occurred. In addition, the study will allow for collection and analysis of additional safety data and usability assessment of the device, medical resource utilization, and health related quality of life measures.


Condition Intervention Phase
Rectal Cancer Anastomotic Leak Device: LifeSeal™ Kit Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study

Further study details as provided by LifeBond Ltd.:

Primary Outcome Measures:
  • Incidence of overall anastomotic leak [ Time Frame: Up to 17 weeks post surgery ]

Secondary Outcome Measures:
  • Incidence of post operative anastomotic leaks [ Time Frame: Up to 17 weeks post surgery ]

Estimated Enrollment: 736
Study Start Date: November 2016
Estimated Study Completion Date: September 2020
Estimated Primary Completion Date: March 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: LifeSeal™ Kit
Stapled Anastomosis is performed according to Standard of Care (SoC) with the addition of LifeSeal™ Kit application during surgery.
Device: LifeSeal™ Kit
LifeSeal™ Kit is applied as an additional protective layer over a stapled anastomosis
No Intervention: Standard of Care
Stapled Anastomosis is performed according to SoC without LifeSeal™ reinforcement.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907385


Contacts
Contact: Sachi Norman, MD +972-4-6340816 sachi@life-bond.com

  Show 27 Study Locations
Sponsors and Collaborators
LifeBond Ltd.
  More Information

Responsible Party: LifeBond Ltd.
ClinicalTrials.gov Identifier: NCT02907385     History of Changes
Other Study ID Numbers: CLP-LS-0131
First Submitted: September 15, 2016
First Posted: September 20, 2016
Last Update Posted: June 6, 2017
Last Verified: June 2017

Keywords provided by LifeBond Ltd.:
Rectal Cancer
Low Anterior Resection
LifeSeal
Surgical Sealant

Additional relevant MeSH terms:
Rectal Neoplasms
Anastomotic Leak
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Intestinal Diseases
Rectal Diseases
Postoperative Complications
Pathologic Processes