Seal-G Safety Study

Sealantis

Status

Completed

Conditions

Elective Surgical Procedures, Digestive System

Treatments

Device: Seal-G

Study type

Interventional

Funder types

Industry

Identifiers

NCT02825173

DLG-072-01

Details and patient eligibility

About

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.

Full 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

Enrollment

20 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is ≥ 18 years old.
Subject is planned to undergo an elective open or laparoscopic colonic resection with the creation of an anastomosis (extracorporeal if laparoscopic surgery is performed).
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.

Exclusion criteria

Subject, undergoing low anterior resection
Subject is planned to undergo an emergency procedure
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, significant vascular disease, active or uncontrolled autoimmune disease, active or uncontrolled infection)
Subject who according to the investigator clinical judgement is at risk for anastomosis dehiscence
Subject has participated in another clinical study which may affect this study's outcomes within the last 30 days
Subject's ASA (American Society of Anesthesiology) score ≥ 4
Subject's BMI > 34 or <16
Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes)
Subject with a life expectancy of less than 1 year
Subject requires more than one anastomosis during the surgery
Woman who is known to be pregnant
Mentally handicapped, prisoners, or legally incompetent

Intraoperative Exclusion Criteria:

Subjects whom anastomosis is less than 10 cm from the anal verge
The full circumference of the anastomosis is not accessible for Seal-G application
Subject received intraoperative sealant, glue or any buttressing material for the study related anastomosis, other than the Seal-G
Subject has excessive intraoperative bleeding prior to the anastomosis formation as assessed by the investigator (estimated in excess of 500mL)
Subject has peritoneal carcinomatosis