Spots Global Cancer Trial Database for Seal-G / Seal-G MIST Study
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Trial Identification
Brief Title: Seal-G / Seal-G MIST Study
Official Title: Seal-G and Seal-G MIST Study for Reinforcement and Protection of Colonic Anastomoses in Subjects Undergoing Colonic Resection
Study ID: NCT04532515
Study Description
Brief 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
Detailed 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.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
Sheba Medical Center (Tel Hashomer), Ramat Gan, , Israel
Shamir (Assaf Harofeh) Medical Center, Rishon LeZion, , Israel
Contact Details
Name: Moshe Kamar, MD
Affiliation: Advanced Medical Solutions Israel (Sealantis) Ltd.
Role: STUDY_DIRECTOR
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