Seal-G / Seal-G MIST Study (DLG-072-06 Rev5.0 18Apr2021)
Research type
Research Study
Full title
Seal-G and Seal-G MIST study for reinforcement and protection of colonic anastomoses in Subjects undergoing colonic resection
IRAS ID
287139
Contact name
David G. Jayne
Contact email
Sponsor organisation
Advanced Medical Solutions Israel (Sealantis) Ltd.
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 5 months, 28 days
Research summary
Seal-G and Seal-G MIST Surgical Sealants are intended for the reinforcement and protection of gastrointestinal anastomoses. The Seal-G and Seal-G MIST 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-corporeal approach (surgery through a large incision, where the surgeon works on the organs outside of the body), and the Seal-G MIST device is designed for spray application by intra-corporeal approach (surgery through a smaller incision, where the surgeon works on the organs inside of the body).
The proposed study aims to collect clinical evidence on the devices’ usage, including safety, performance and usability.REC name
West Midlands - South Birmingham Research Ethics Committee
REC reference
21/WM/0127
Date of REC Opinion
25 May 2021
REC opinion
Favourable Opinion