Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Lead
Sealantis Ltd.
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)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
