NCT03448874

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

Seal-G MIST System Safety Study [SEALAR Study]

• Status: Withdrawn
• Phase: N/A
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Sealantis Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed 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)

Conditions

• Colorectal Cancer
• Diverticulitis Colon

Interventions

Type	Name	Description
DEVICE	Seal-G MIST System	Seal-G MIST is an adjunct device that will be applied adjunctively to cover standard closure techniques.

Timeline

• Start date: 2018-04-01
• Primary completion: 2019-04-01
• Completion: 2019-07-01
• First posted: 2018-02-28
• Last updated: 2020-07-30