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Clinical Trial Summary

A prospective, multi-center, open label, study to evaluate safety and performance of Seal-G and Seal-G MIST in reinforcing colonic anastomosis, in subjects undergoing Colon Resection surgery


Clinical Trial Description

Seal-G and Seal-G MIST Surgical Sealants are intended for the reinforcement and protection of gastrointestinal anastomosis. The Seal-G and Seal-G MIST devices share the same Alginate based sealant technology and intended purpose. The devices only differ in their method of application, The Seal-G device is designed for spread application by extra-corporal approach, and the Seal-G MIST device is designed for spray application by intra-corporal approach. The proposed Clinical Investigation aims to collect clinical evidence on the devices' usage, including safety, performance and usability. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04532515
Study type Interventional
Source Advanced Medical Solutions Ltd.
Contact
Status Completed
Phase N/A
Start date February 1, 2021
Completion date October 30, 2023

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