Seal-G / Seal-G MIST Study
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- Colon Cancer
- Gastrointestinal Cancer
- Type
- Interventional
- Phase
- Not Applicable
- Design
- Allocation: N/AIntervention Model: Single Group AssignmentIntervention Model Description: Seal-G Product Family variants will be used as the study device (Treatment) according to the following scheme: Seal-G Surgical Sealant [Seal-G]- will be applied on colonic anastomosis created by extra-corporal approach. Seal-G MIST System [Seal-G MIST]- will be applied on colonic anastomosis created by intra-corporal approach. Intended Use: Seal-G/Seal-G MIST are surgical sealants intended for use as an adjunct to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses. Device is an adjunct device and will be applied following standard colon resection surgery and creation of primary anastomosisMasking: None (Open Label)Primary Purpose: Supportive Care
Participation Requirements
- Age
- Between 18 years and 80 years
- Gender
- Both males and females
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 dev...
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.
Tracking Information
- NCT #
- NCT04532515
- Collaborators
- ClinSearch
- Advanced Medical Solutions Israel (Sealantis) Ltd.
- Investigators
- Study Director: Moshe Kamar, MD Advanced Medical Solutions Israel (Sealantis) Ltd.
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