Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]
- Conditions
- Colorectal CancerDiverticulitis Colon
- Interventions
- Device: Seal-G MIST System
- Registration Number
- NCT03448874
- Lead Sponsor
- Sealantis Ltd.
- Brief 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)
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Subject >18 years
- Subject is scheduled for elective open or laparoscopic colorectal resection (including left colectomy, sigmoidectomy, anterior resection, subtotal colectomy) surgery (including robotic) involving the creation of circular stapler anastomosis
- Subject signs and dates a written Informed Consent Form, indicates an understanding of the study procedures and follow-up requirements and is willing to comply with them
- 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 American Society of Anesthesiologists (ASA) status higher than 3
- Albumin level < 3 gr/dl
- Hemoglobin level < 8 g/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 diabetes mellitus 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 (E132)
- Subject who according to the investigator clinical judgement is not suitable for participation in the study
- Subject with a life expectancy of less than 1 year
- Subject requires more than one anastomosis during the surgery
- Subject is scheduled for another surgery during the follow up period of this study
- Subject participating in any other study involving an investigational (unapproved) drug or device
- Woman who is known to be pregnant or breast-feeding or woman who is planning pregnancy or breast-feeding in the 5 next months
- Vulnerable subjects (e.g. mentally handicapped, prisoners, etc.)
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Seal-G MIST System Seal-G MIST System Seal-G MIST System is a surgical sealant that will be applied adjunctively to standard closure techniques for reinforcement and protection of gastrointestinal anastomoses.
- Primary Outcome Measures
Name Time Method Incidence of overall subject pre-specified* procedure related Adverse Events up to 15 weeks (±2 weeks) post-surgery Pre-specified procedure related Adverse Event: Wound infection; Bowel obstruction and Post-operative ileus; Anastomotic stricture; Anastomotic leak; Collection/Abscess; Urinary retention/Urinary Tract Infection; Renal failure; Hepatic failure; Peritoneal metastasis; Staple-line bleeding; Allergic reaction; Re-intervention (Including but not limited to re-operation; stoma).
- Secondary Outcome Measures
Name Time Method Incidence of "deployment failure" during surgery only for treatment arm
Incidence of collection/abscess without demonstrated leak up to 15 weeks (±2 weeks) post-surgery According to Adverse event reporting form
Incidence of reoperation up to 30 days post-surgery According to Adverse event/Serious Adverse Event reporting form
Incidence of postoperative mortality up to 15 weeks (±2 weeks) Incidence of clinical anastomotic leaks up to 15 weeks (±2 weeks) post-surgery Anastomotic leak (AL) is defined as evidence of a defect in the intestinal wall integrity at the anastomotic site leading to local or general peritonitis, abscesses in the proximity of the anastomosis and/or fistula, fecal or purulent discharge from drains.
Incidence of subclinical/ radiological leaks up to 15 weeks (±2 weeks) post-surgery As assessed from Adverse event/Serious Adverse Event reporting form
Incidence of Serious Adverse Events (SAE) complications up to 15 weeks (±2 weeks) post-surgery According to Serious Adverse Event (SAE) definition from Medical Device Directive (MEDDEV 2.7/3, Rev 3, May 2015)
Hospital length of stay From date of surgery until the time for "Ready to be discharged" (in days), an average of 10±4 days