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

Rectal Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02907385
• Other study ID #: CLP-LS-0131
• 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
• 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.

Related Conditions & MeSH terms

• Anastomotic Leak
• Rectal Cancer
• Rectal Neoplasms

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