Seal-G / Seal-G MIST Study

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.

Inclusion criteria

• Subject signs and dates a written ICF, indicates an understanding of the study procedures and follow-up requirements and is willing to comply with them.
• Subject is aged 18 years to 80 years
• Subject is scheduled for elective open or laparoscopic (including robotic) colon cancer resection surgery with primary anastomosis (excluding low anterior resection)

Exclusion criteria

• Anastomosis is expected to be ≤ 10cm from anal verge
• Surgery involves stoma creation
• Subject who underwent a prior pelvic radiation therapy
• Subject with a BMI > 40 or <19
• Subject with ASA status higher than 3
• Albumin level < 3 gr/dl
• Total bilirubin >1.5 mg/dL
• Hemoglobin level < 8mg/dl on day of surgery
• Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis
• Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids)
• Serious or uncontrolled co-existent diseases (e.g. severe cardiovascular disease, congestive heart failure, recent myocardial infarction within 6 months from surgery, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection, uncontrolled DM with episodes of hospitalization due to hypo or hyperglycemia within 6 months of surgery)
• Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
• Subject with known sensitivity to Indigo carmine dye (FD&C 2/ E132)
• Subject who according to the investigator clinical judgement is not suitable for participation in the study or is at risk
• Subject requires more than one anastomosis during the surgery
• Subject is scheduled for another surgery during the follow up period of this study
• Subjects who cannot comply with study visits/ procedures or have poor compliance (e.g. mentally handicapped, prisoners, etc.)

Intraoperative Exclusion Criteria:

Subjects who meet any of the following intra-operative exclusion criteria will be considered as screen failures and will not be eligible for the study:

• Positive leak test requires anastomosis takedown and/or re-anastomosis.
• Additional resection (not including tissue biopsy) of non-colonic solid organ (e.g. Liver resection, uterus, bladder, seminal vesicle, ureter)
• Subjects whom anastomosis is ≤10 cm from the anal verge
• Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G/Seal-G MIST
• Subject received two or more units of PC transfusion during surgery
• Subject has peritoneal carcinomatosis or any other metastasis observed by the surgeon