Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
1 other identifier
interventional
736
7 countries
39
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Nov 2016
Typical duration for phase_3
39 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 15, 2016
CompletedFirst Posted
Study publicly available on registry
September 20, 2016
CompletedStudy Start
First participant enrolled
November 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2020
CompletedMarch 30, 2018
March 1, 2018
1.3 years
September 15, 2016
March 29, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of overall anastomotic leak
Up to 17 weeks post surgery
Secondary Outcomes (1)
Incidence of post operative anastomotic leaks
Up to 17 weeks post surgery
Study Arms (2)
LifeSeal™ Kit
EXPERIMENTALStapled Anastomosis is performed according to Standard of Care (SoC) with the addition of LifeSeal™ Kit application during surgery.
Standard of Care
NO INTERVENTIONStapled Anastomosis is performed according to SoC without LifeSeal™ reinforcement.
Interventions
LifeSeal™ Kit is applied as an additional protective layer over a stapled anastomosis
Eligibility Criteria
You may qualify if:
- Male or female ≥ 21 years of age at Screening Visit.
- Written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study.
- Subject is diagnosed with colorectal cancer
- 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.
- Procedure involving Total Mesorectal Excision by an abdominal or transanal approach.
- 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
You may not qualify if:
- Female subject who is pregnant, breastfeeding, or if of child bearing potential is unwilling to practice birth control until 3 years following surgery.
- 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.
- Subject has a history of hypersensitivity to porcine derived gelatin or collagen.
- Subject has a history of hypersensitivity to microbial Transglutaminase.
- Subject has a known dysfibrinogenemia, hypofibrinogenemia or a fibrinogenemia, without preoperative correction of fibrinogen levels.
- Subject participating in any other study involving an investigational (unapproved) drug or device within the past 60 days.
- Subject participating in studies involving approved drug or device will be enrolled only following a mutual consideration of the investigator together with the Sponsor.
- Subject with a BMI ≥50, which may interfere with access to the surgical site and increase overall operative risk.
- Subject with American Society of Anesthesiology (ASA) status higher than 3.
- Avastin use within 30 days prior to surgery.
- Subject who has undergone a prior pelvic anastomosis.
- 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).
- Subject with an active abdominal or pelvic infection at the operation site.
- Subject has been previously treated with LifeSeal™ Surgical Sealant.
- Subject received intra-operative sealant, glue or any buttressing material other than the LifeSeal™ Surgical Sealant.
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- LifeBond Ltd.lead
Study Sites (39)
University of Southern CA
Los Angeles, California, United States
Stanford University
Stanford, California, United States
Florida Hospital
Florida City, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
University of Chicago
Chicago, Illinois, United States
Franciscan
Indianapolis, Indiana, United States
Indiana University
Indianapolis, Indiana, United States
Ochsner Clinic Foundation
Jefferson, Louisiana, United States
Johns Hopkins Hospital
Baltimore, Maryland, United States
Medical University SC (MUSC)
Worcester, Massachusetts, United States
University of Massachusetts
Worcester, Massachusetts, United States
Spectrum Health
Grand Rapids, Michigan, United States
Washington University
St Louis, Missouri, United States
Albany medical center
Albany, New York, United States
New York University
New York, New York, United States
Cleveland Clinic
Cleveland, Ohio, United States
University Hospital Cleveland Medical Center
Cleveland, Ohio, United States
Penn state university
State College, Pennsylvania, United States
Duke University
Durham, South Carolina, United States
University of Vermont
Burlington, Vermont, United States
University of Virginia
Charlottesville, Virginia, United States
Medical College of Wisconsin
Milwaukee, Wisconsin, United States
OLV Ziekenhuis Aalst
Aalst, Belgium
Ziekenhuis Oost-Limburg
Genk, Belgium
Gent University Hospital
Ghent, Belgium
University Hospital Leuven
Leuven, Belgium
Bispebjerg Hospital
Copenhagen, Denmark
Zealand University Hospital
Roskilde, Denmark
Beilinson Rabin Medical Center
Petah Tikva, Israel
Sourasky Medical Center
Tel Aviv, Israel
Assaf Harofeh Medical Center
Tzrifin, Israel
Policlinico S.Orsola Malpighi
Bologna, Italy
Humanitas Research Hospital
Milan, Italy
University of Padova
Padua, Italy
Catharina Hospital Eindhoven
Eindhoven, Netherlands
Lund University Hospital
Malmo, Sweden
Karolinska University Hospital
Stockholm, Sweden
Uppsala University Hospital
Uppsala, Sweden
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2016
First Posted
September 20, 2016
Study Start
November 1, 2016
Primary Completion
March 1, 2018
Study Completion
September 1, 2020
Last Updated
March 30, 2018
Record last verified: 2018-03