NCT03448874WithdrawnNot Applicable
Seal-G MIST System Safety Study [SEALAR Study]
Sealantis Ltd.0 sitesStarted: April 1, 2018Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Withdrawn
- Sponsor
- Primary Endpoint
- Incidence of overall subject pre-specified* procedure related Adverse Events
Study Overview
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).
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Masking Description
This study is single blinded. The subject will be blinded to the treatment arm; however, by nature of the type of the proposed study, blinding of the investigator/ surgeon is not feasible. In order to minimize bias, subjects will be randomized during the surgery upon confirmation of the intra-operative exclusion criteria. This will ensure that the surgeon will not know prior to surgery and until completion of anastomosis creation, whether or not Seal-G MIST will be used.
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
Exclusion Criteria
- •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.)
Outcomes
Primary Outcomes
Incidence of overall subject pre-specified* procedure related Adverse Events
Time Frame: 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 Outcomes
- Incidence of "deployment failure"(during surgery)
- Incidence of collection/abscess without demonstrated leak(up to 15 weeks (±2 weeks) post-surgery)
- Incidence of reoperation(up to 30 days post-surgery)
- Incidence of postoperative mortality(up to 15 weeks (±2 weeks))
- Incidence of clinical anastomotic leaks(up to 15 weeks (±2 weeks) post-surgery)
- Incidence of subclinical/ radiological leaks(up to 15 weeks (±2 weeks) post-surgery)
- Incidence of Serious Adverse Events (SAE) complications(up to 15 weeks (±2 weeks) post-surgery)
- Hospital length of stay(From date of surgery until the time for "Ready to be discharged" (in days), an average of 10±4 days)
Investigators
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