Elective Surgical Procedures, Digestive System Clinical Trial
Official title:
A Prospective, Multi-center, Open Label, Non-randomized Study, of Seal-G Surgical Sealant for the Reinforcement of Gastrointestinal Anastomosis
The purpose of this study is to farther assess the safety of the Seal-G Surgical Sealant for the reinforcement and protection of gastrointestinal anastomosis.
Pre-Surgery:
Screening will be performed among adult subjects who are scheduled for an elective
colorectal surgery. Pre-surgery assessments (after completion of consent process and signed
ICF) will be according to the routine practice.
Intra-operative:
During surgery, an assessment of the intra-operative exclusion criteria will be performed.
If the subject does not meet any of the exclusion criteria, the subject will be further
enrolled. Surgery will be performed according to the site standard of care (routine
practice). Anastomosis will be created either using a stapler device (linear or circular),
according to manufacture IFU (Instructions for use) or hand suture according to surgeon best
practice technique. Once anastomosis has been created, surgeon will verify the anastomosis
and mucosal donuts integrity.
Device (Seal-G) application on anastomotic site
Post-operative follow-up: Follow-up evaluations will be performed daily while hospitalized.
There will be one postoperative follow up at one month - clinic visit
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