Last updated: December 5, 2023
Sponsor: Advanced Medical Solutions Ltd.
Overall Status: Completed
Phase
N/A
Condition
Colon Cancer
Gastric Ulcers
Colorectal Cancer
Treatment
Seal-G MIST System
Seal-G Surgical Sealant
Clinical Study ID
NCT04532515
DLG-072-06
Ages 18-80 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- Subject signs and dates a written ICF, indicates an understanding of the studyprocedures and follow-up requirements and is willing to comply with them.
- Subject is aged 18 years to 80 years
- Subject is scheduled for elective open or laparoscopic (including robotic) coloncancer resection surgery with primary anastomosis (excluding low anterior resection)
Exclusion
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 ASA status higher than 3
- Albumin level < 3 gr/dl
- Total bilirubin >1.5 mg/dL
- Hemoglobin level < 8mg/dl on day of surgery
- Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, localor 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 oruncontrolled infection, uncontrolled DM with episodes of hospitalization due to hypoor 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 (FD&C 2/ E132)
- Subject who according to the investigator clinical judgement is not suitable forparticipation in the study or is at risk
- Subject requires more than one anastomosis during the surgery
- Subject is scheduled for another surgery during the follow up period of this study
- Subjects who cannot comply with study visits/ procedures or have poor compliance (e.g.mentally handicapped, prisoners, etc.) Intraoperative Exclusion Criteria: Subjects who meet any of the following intra-operative exclusion criteria will beconsidered as screen failures and will not be eligible for the study:
- Positive leak test requires anastomosis takedown and/or re-anastomosis.
- Additional resection (not including tissue biopsy) of non-colonic solid organ (e.g.Liver resection, uterus, bladder, seminal vesicle, ureter)
- Subjects whom anastomosis is ≤10 cm from the anal verge
- Subject received intraoperative sealant, glue or any buttressing material for thestudy related anastomosis, other than the Seal-G/Seal-G MIST
- Subject received two or more units of PC transfusion during surgery
- Subject has peritoneal carcinomatosis or any other metastasis observed by the surgeon
Study Design
Total Participants: 160
Treatment Group(s): 2
Primary Treatment: Seal-G MIST System
Phase:
Study Start date:
February 01, 2021
Estimated Completion Date:
October 30, 2023
Study Description
Connect with a study center
Sheba Medical Center (Tel Hashomer)
Ramat Gan,
IsraelSite Not Available
Shamir (Assaf Harofeh) Medical Center
Rishon LeZion,
IsraelSite Not Available
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