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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02907385
Other study ID # CLP-LS-0131
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received September 15, 2016
Last updated March 29, 2018
Start date November 2016
Est. completion date September 2020

Study information

Verified date March 2018
Source LifeBond Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 736
Est. completion date September 2020
Est. primary completion date March 2018
Accepts healthy volunteers No
Gender All
Age group 21 Years and older
Eligibility 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


Related Conditions & MeSH terms


Intervention

Device:
LifeSeal™ Kit
LifeSeal™ Kit is applied as an additional protective layer over a stapled anastomosis

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
LifeBond Ltd.

Countries where clinical trial is conducted

United States,  Belgium,  Denmark,  Israel,  Italy,  Netherlands,  Sweden, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence of overall anastomotic leak Up to 17 weeks post surgery
Secondary Incidence of post operative anastomotic leaks Up to 17 weeks post surgery
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