NCT02825173

Seal-G Safety Study

A Prospective, Multi-center, Open Label, Non-randomized Study, of Seal-G Surgical Sealant for the Reinforcement of Gastrointestinal Anastomosis

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Sealantis Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Elective Surgical Procedures, Digestive System

Interventions

Type	Name	Description
DEVICE	Seal-G	Intervention: Device: Seal-G Seal-G is applied adjunctively to cover standard closure techniques

Timeline

• Start date: 2016-08-01
• Primary completion: 2016-11-01
• Completion: 2016-12-02
• First posted: 2016-07-07
• Last updated: 2017-04-27

Locations

3 sites across 2 countries: Israel, Italy