For Healthcare Professionals

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

clipboard-pencil

About the study

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.
user-3

Who can take part

You may be eligible to participate in the study if you meet the following 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

    pin location

    Study Locations

    Enter your ZIP code/Postal code/PIN code to locate study sites near you:

    How to Apply


    Contact the study center to learn if this study is a good match for you.
    Phone iconCall +972-4-6340816Email iconEmail Study Center

    Study’s details


    Contition

    Anastomotic Leak,Rectal Cancer

    Age

    21+

    Phase

    Phase 3

    Participants needed

    736

    Est. Completion Date

    Sep 2020

    Treatment type

    Interventional


    Sponsor

    LifeBond Ltd.

    ClinicalTrials.gov identifier

    NCT02907385

    Study number

    CLP-LS-0131

    Understanding Clinical Trials


    Get answers to your questions about clinical trials.What is a clinical research?What does taking part in clinical trials involve?What should I ask the trial doctor?
    Vector

    Interested?

    Sign up to save your favorites, 
    receive newsletters, resources, and alerts 
    about clinical trials related to your conditions of interest.