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

Phase 3

• Conditions: Anastomotic Leak; Rectal Cancer
• Interventions: Device: LifeSeal™ Kit

• Registration Number: NCT02907385
• Lead Sponsor: LifeBond Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-09-15
• Study First Submitted QC: 2016-09-19
• Study First Posted: 2016-09-20
• Study Start: 2016-11
• Status Verified: 2018-03
• Primary Completion: 2018-03
• Last Update Submitted: 2018-03-29
• Last Update Posted: 2018-03-30
• Study Completion: 2020-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 736

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LifeSeal™ Kit	LifeSeal™ Kit	Stapled Anastomosis is performed according to Standard of Care (SoC) with the addition of LifeSeal™ Kit application during surgery.

Primary Outcome Measures

Name	Time	Method
Incidence of overall anastomotic leak	Up to 17 weeks post surgery

Secondary Outcome Measures

Name	Time	Method
Incidence of post operative anastomotic leaks	Up to 17 weeks post surgery

Trial Locations

Locations (39)

Medical University SC (MUSC); 🇺🇸 Worcester, Massachusetts, United States

Penn state university; 🇺🇸 State College, Pennsylvania, United States

University of Vermont; 🇺🇸 Burlington, Vermont, United States

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

Franciscan; 🇺🇸 Indianapolis, Indiana, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States

Albany medical center; 🇺🇸 Albany, New York, United States

Ochsner Clinic Foundation; 🇺🇸 Jefferson, Louisiana, United States

University of Massachusetts; 🇺🇸 Worcester, Massachusetts, United States

Spectrum Health; 🇺🇸 Grand Rapids, Michigan, United States

University Hospital Cleveland Medical Center; 🇺🇸 Cleveland, Ohio, United States

New York University; 🇺🇸 New York, New York, United States

Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Beilinson Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Catharina Hospital Eindhoven; 🇳🇱 Eindhoven, Netherlands

Florida Hospital; 🇺🇸 Florida City, Florida, United States

Stanford University; 🇺🇸 Stanford, California, United States

University of Southern CA; 🇺🇸 Los Angeles, California, United States

University of Chicago; 🇺🇸 Chicago, Illinois, United States

Cleveland Clinic Florida; 🇺🇸 Weston, Florida, United States

Cleveland Clinic; 🇺🇸 Cleveland, Ohio, United States

University of Virginia; 🇺🇸 Charlottesville, Virginia, United States

Zealand University Hospital; 🇩🇰 Roskilde, Denmark

Gent University Hospital; 🇧🇪 Gent, Belgium

OLV Ziekenhuis Aalst; 🇧🇪 Aalst, Belgium

Ziekenhuis Oost-Limburg; 🇧🇪 Genk, Belgium

University Hospital Leuven; 🇧🇪 Leuven, Belgium

Policlinico S.Orsola Malpighi; 🇮🇹 Bologna, Italy

Humanitas Research Hospital; 🇮🇹 Milano, Italy

University of Padova; 🇮🇹 Padova, Italy

Assaf Harofeh Medical Center; 🇮🇱 Tzrifin, Israel

Lund University Hospital; 🇸🇪 Malmö, Sweden

Karolinska University Hospital; 🇸🇪 Stockholm, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Tampa General Hospital; 🇺🇸 Tampa, Florida, United States

Washington University; 🇺🇸 Saint Louis, Missouri, United States

Duke University; 🇺🇸 Durham, South Carolina, United States

Medical College of Wisconsin; 🇺🇸 Milwaukee, Wisconsin, United States

Bispebjerg Hospital; 🇩🇰 Copenhagen, Denmark