Status:
WITHDRAWN
Seal-G MIST (Minimally Invasive Sealant/Spray Technology) System Safety Study [SEALAR Study]
Lead Sponsor:
Sealantis Ltd.
Conditions:
Colorectal Cancer
Diverticulitis Colon
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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.)
Key Trial Info
Start Date :
April 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2019
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT03448874
Start Date
April 1 2018
End Date
July 1 2019
Last Update
July 30 2020
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