Efficacy and Safety of LifeSeal™ Kit for Colorectal Staple Line Sealing
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02907385|
Recruitment Status : Active, not recruiting
First Posted : September 20, 2016
Last Update Posted : March 30, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Rectal Cancer Anastomotic Leak||Device: LifeSeal™ Kit||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||736 participants|
|Intervention Model:||Parallel Assignment|
|Official Title:||Efficacy and Safety of LifeSeal™ Kit for Staple Line Sealing in Colorectal and Coloanal Anastomoses: A Prospective Randomized Study|
|Study Start Date :||November 2016|
|Estimated Primary Completion Date :||March 2018|
|Estimated Study Completion Date :||September 2020|
Experimental: LifeSeal™ Kit
Stapled Anastomosis is performed according to Standard of Care (SoC) with the addition of LifeSeal™ Kit application during surgery.
Device: LifeSeal™ Kit
LifeSeal™ Kit is applied as an additional protective layer over a stapled anastomosis
No Intervention: Standard of Care
Stapled Anastomosis is performed according to SoC without LifeSeal™ reinforcement.
- Incidence of overall anastomotic leak [ Time Frame: Up to 17 weeks post surgery ]
- Incidence of post operative anastomotic leaks [ Time Frame: Up to 17 weeks post surgery ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907385
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