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
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
160
Seal-G is a surgical sealant 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 anastomosis
Seal-G MIST is a surgical sealant 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 anastomosis
Sheba Medical Center (Tel Hashomer)
Ramat Gan, Israel
Shamir (Assaf Harofeh) Medical Center
Rishon LeZiyyon, Israel
Proportion of surgeries with full sealant coverage - successful application
1- The surgeon applied the sealant over the full circumference of the anastomosis (successful application). 0 - The surgeon did not fully cover the anastomosis circumference
Time frame: At time of surgery
Proportion of subjects with clinical anastomotic leaks
1 - The subject had a clinical anastomotic leak 0 - The subject did not have a clinical anastomotic leak
Time frame: Up to 30 days post-surgery
Proportion of subjects with subclinical / radiological leaks
1 - The subject had a Subclinical /radiological anastomotic leak 0 - The subject did not have a Subclinical /radiological anastomotic leak
Time frame: Up to 30 days post-surgery
Proportion of subjects with at least one Serious Adverse Event
1 - The subject had any Serious adverse event 0 - The subject did not have Serious adverse event
Time frame: Up to 30 days post-surgery
Proportion of subjects that had a reoperation
1 - The subject had any event of reoperation 0 - The subject did not have reoperation
Time frame: Up to 30 days post-surgery
Hospital length of stay
Measured by the time for "Ready to be discharged" (in days)
Time frame: Up to 30 days post-surgery
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.