Neoplasms

Digestive System Diseases

All Conditions

Rectal Neoplasms

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Intestinal Diseases

Rectal Diseases

Standard of Care Arm - subjects treated by routine manner

LifeSeal™ Kit Arm - subjects treated with the LifeSeal™ Kit device + Standard of Care treatment

Application of LifeSeal™ Kit for staple line reinforcement during open GI surgeries in Low Anterior Resection

LifeSeal™ Kit

A preliminary Study in Subjects Undergoing Low Anterior Resection

LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection

Surgeon will complete a questionnaire regarding the device use and ease of application

LifeBond Ltd.

Symptoms and General Pathology

Anastomotic Leak

Postoperative Complications

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

Stapled Anastomosis is performed according to SoC without LifeSeal™ reinforcement.

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

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.

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

The anastomosis will be created using Standard of Care only

The anastomosis will be created using SOC + LifeSeal™ Kit

A Pilot Study in Subjects Undergoing circular stapled anastomosis created within 10 cm of the anal verge.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection	NCT01790230	Rectal Cancer	LifeSeal™ Kit	18 Years -	LifeBond Ltd.
LifeSeal™ Preliminary Study in Subjects Undergoing Low Anterior Resection	NCT01790230	Rectal Cancer	LifeSeal™ Kit	18 Years -	LifeBond Ltd.
Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing	NCT02907385	Rectal Cancer Anastomotic Lea...	LifeSeal™ Kit	21 Years -	LifeBond Ltd.
LifeSeal™ Pilot Study in Subjects Undergoing Circular Stapled Anastomosis Created Within 10 cm of the Anal Verge	NCT02046278	Rectal Cancer	LifeSeal™ Kit	18 Years - 90 Years	LifeBond Ltd.

Spots Global Cancer Trial Database for lifeseal™ kit