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

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

Status

UNKNOWN

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02907385

Enrollment

736

Registered

2016-09-20

Start date

2016-11-30

Completion date

2020-09-30

Last updated

2018-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anastomotic Leak, Rectal Cancer

Keywords

Rectal Cancer, Low Anterior Resection, LifeSeal, Surgical Sealant

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.

Interventions

DEVICELifeSeal™ Kit

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Eligibility

Sex/Gender

ALL

Age

21 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Incidence of overall anastomotic leak	Up to 17 weeks post surgery

Secondary

Measure	Time frame
Incidence of post operative anastomotic leaks	Up to 17 weeks post surgery

Countries

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026