Colorectal Cancer Clinical Trial
— SEALAROfficial title:
Seal-G MIST System Safety Study [SEALAR Study]
NCT number | NCT03448874 |
Other study ID # | DLG-072-06 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | April 2018 |
Est. completion date | July 2019 |
Verified date | July 2020 |
Source | Sealantis Ltd. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate safety of Seal-G MIST System in reinforcing colorectal anastomosis, in subjects undergoing colorectal surgery.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | July 2019 |
Est. primary completion date | April 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Subject >18 years 2. 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 3. 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: 1. Anastomosis is expected to be = 10cm from anal verge 2. Surgery involves stoma creation 3. Subject who underwent a prior pelvic radiation therapy 4. Subject with a BMI > 40 or <19 5. Subject with American Society of Anesthesiologists (ASA) status higher than 3 6. Albumin level < 3 gr/dl 7. Hemoglobin level < 8 g/dl on day of surgery 8. Subject has a diagnosis of bowel strangulation, peritonitis, bowel perforation, local or systemic infection, ischemic bowel, and carcinomatosis 9. Subject treated with immunosuppressive agents within 28 days prior to study enrollment (including corticosteroids) 10. 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) 11. Subject known to have distant metastases, such as liver, lung, bone etc. metastases (not including local and regional lymph nodes) 12. Subject with known sensitivity to Indigo carmine dye (E132) 13. Subject who according to the investigator clinical judgement is not suitable for participation in the study 14. Subject with a life expectancy of less than 1 year 15. Subject requires more than one anastomosis during the surgery 16. Subject is scheduled for another surgery during the follow up period of this study 17. Subject participating in any other study involving an investigational (unapproved) drug or device 18. Woman who is known to be pregnant or breast-feeding or woman who is planning pregnancy or breast-feeding in the 5 next months 19. Vulnerable subjects (e.g. mentally handicapped, prisoners, etc.) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Sealantis Ltd. |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Incidence of overall subject pre-specified* procedure related Adverse Events | 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). | up to 15 weeks (±2 weeks) post-surgery | |
Secondary | Incidence of clinical anastomotic leaks | 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. | up to 15 weeks (±2 weeks) post-surgery | |
Secondary | Incidence of subclinical/ radiological leaks | As assessed from Adverse event/Serious Adverse Event reporting form | up to 15 weeks (±2 weeks) post-surgery | |
Secondary | Incidence of Serious Adverse Events (SAE) complications | According to Serious Adverse Event (SAE) definition from Medical Device Directive (MEDDEV 2.7/3, Rev 3, May 2015) | up to 15 weeks (±2 weeks) post-surgery | |
Secondary | Incidence of collection/abscess without demonstrated leak | According to Adverse event reporting form | up to 15 weeks (±2 weeks) post-surgery | |
Secondary | Incidence of reoperation | According to Adverse event/Serious Adverse Event reporting form | up to 30 days post-surgery | |
Secondary | Incidence of postoperative mortality | up to 15 weeks (±2 weeks) | ||
Secondary | Hospital length of stay | From date of surgery until the time for "Ready to be discharged" (in days), an average of 10±4 days | ||
Secondary | Incidence of "deployment failure" | only for treatment arm | during surgery |
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