Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study] — SEALAR  

Colorectal Cancer Clinical Trial

Official title: Seal-G MIST System Safety Study [SEALAR Study]

Status Withdrawn

Clinical Trial Summary

The purpose of this study is to evaluate safety of Seal-G MIST System in reinforcing colorectal anastomosis, in subjects undergoing colorectal surgery.

Clinical Trial Description

Study procedures:

Pre-surgery:

• Screening will be performed among adult subjects who are scheduled for an elective colorectal surgery. Once potential eligibility to the study is determined based on the study's inclusion/exclusion criteria, study procedures will be explained to the candidate and participation will be offered.

• Informed consent process.

• Pre-surgery assessments will be according to the routine practice at the site and determined by the treating physician.

Intra-operative:

• During the surgery, after confirmation of the intra-operative exclusion criteria, completion of anastomosis creation and only after leak test was performed , subjects will be allocated to one of the two treatment arms with a 1:1 ratio based on a randomization scheme (either to the Standard of care (SOC) or to Seal-G MIST arms).

• Device (Seal-G MIST System) application (to Seal-G MIST treatment arm only).

Post-operative follow-up:

• Subjects will be followed during post-operative period until discharge from the hospital for clinical and subclinical leaks according to the SOC.

• In an event of suspected anastomotic leak, patient will be treated according to severity of leak and PI clinical judgement (conservative treatment, drainage, diversion, anastomosis take down).

• Subjects will be followed up for leaks and related AE/SAEs at the day of the surgery and for a period of 15 weeks (±2 weeks) post-surgery, including the following activities:

• Daily while hospitalized (in accordance with the site routine procedures)

• At 1 month (±1 week) and 15 weeks (±2 weeks) post-surgery (Hospitalization for elective procedure (i.e. chemotherapy treatments) will not be considered as SAEs) ;

Related Conditions & MeSH terms

• Colorectal Cancer
• Diverticulitis
• Diverticulitis Colon
• Diverticulitis, Colonic

• NCT number: NCT03448874
• Study type: Interventional
• Source: Sealantis Ltd.
• Status: Withdrawn
• Phase: N/A
• Start date: April 2018
• Completion date: July 2019