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

March 29, 2018 updated by: LifeBond Ltd.

Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized 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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

736

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Aalst, Belgium
        • OLV Ziekenhuis Aalst
      • Genk, Belgium
        • Ziekenhuis Oost-Limburg
      • Gent, Belgium
        • Gent University Hospital
      • Leuven, Belgium
        • University Hospital Leuven
  • Denmark
      • Copenhagen, Denmark
        • Bispebjerg Hospital
      • Roskilde, Denmark
        • Zealand University Hospital
  • Israel
      • Petah Tikva, Israel
        • Beilinson Rabin Medical Center
      • Tel Aviv, Israel
        • Sourasky Medical Center
      • Tzrifin, Israel
        • Assaf Harofeh Medical Center
  • Italy
      • Bologna, Italy
        • Policlinico S.Orsola Malpighi
      • Milano, Italy
        • Humanitas Research Hospital
      • Padova, Italy
        • University of Padova
  • Netherlands
      • Eindhoven, Netherlands
        • Catharina Hospital Eindhoven
  • Sweden
      • Malmö, Sweden
        • Lund University Hospital
      • Stockholm, Sweden
        • Karolinska University Hospital
      • Uppsala, Sweden
        • Uppsala University Hospital
  • United States
    • California
      • Los Angeles, California, United States
        • University of Southern CA
      • Stanford, California, United States
        • Stanford University
    • Florida
      • Florida City, Florida, United States
        • Florida Hospital
      • Tampa, Florida, United States
        • Tampa General Hospital
      • Weston, Florida, United States
        • Cleveland Clinic Florida
    • Illinois
      • Chicago, Illinois, United States
        • University of Chicago
    • Indiana
      • Indianapolis, Indiana, United States
        • Indiana University
      • Indianapolis, Indiana, United States
        • Franciscan
    • Louisiana
      • Jefferson, Louisiana, United States
        • Ochsner Clinic Foundation
    • Maryland
      • Baltimore, Maryland, United States
        • Johns Hopkins Hospital
    • Massachusetts
      • Worcester, Massachusetts, United States
        • University of Massachusetts
      • Worcester, Massachusetts, United States
        • Medical University SC (MUSC)
    • Michigan
      • Grand Rapids, Michigan, United States
        • Spectrum Health
    • Missouri
      • Saint Louis, Missouri, United States
        • Washington University
    • New York
      • Albany, New York, United States
        • Albany Medical Center
      • New York, New York, United States
        • New York University
    • Ohio
      • Cleveland, Ohio, United States
        • Cleveland Clinic
      • Cleveland, Ohio, United States
        • University Hospital Cleveland Medical Center
    • Pennsylvania
      • State College, Pennsylvania, United States
        • Penn State University
    • South Carolina
      • Durham, South Carolina, United States
        • Duke University
    • Vermont
      • Burlington, Vermont, United States
        • University of Vermont
    • Virginia
      • Charlottesville, Virginia, United States
        • University of Virginia
    • Wisconsin
      • Milwaukee, Wisconsin, United States
        • Medical College of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

    -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence of overall anastomotic leak
Time Frame: Up to 17 weeks post surgery
Up to 17 weeks post surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Incidence of post operative anastomotic leaks
Time Frame: Up to 17 weeks post surgery
Up to 17 weeks post surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

LifeBond Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2016

Primary Completion (Anticipated)

March 1, 2018

Study Completion (Anticipated)

September 1, 2020

Study Registration Dates

First Submitted

September 15, 2016

First Submitted That Met QC Criteria

September 19, 2016

First Posted (Estimate)

September 20, 2016

Study Record Updates

Last Update Posted (Actual)

March 30, 2018

Last Update Submitted That Met QC Criteria

March 29, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CLP-LS-0131

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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