A Prospective, Multi-site, Single Cohort, Non-controlled, Non-randomized Clinical Trial Evaluating the Usefulness of CADISS® System for the Cleavage of Severe Adhesions in Acute Cholecystitis (Cholecystectomy)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- AuXin Surgery SA
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Ability of the CADISS® System to dissect adherences without cutting
Study Overview
Brief Summary
Acute cholecystitis is the most common complication of cholelithiasis. Acute cholecystitis is inflammation of the gallbladder that develops over hours, usually due to an obstruction of the cystic duct by a gallstone. Removal of the gallbladder (Cholecystectomy) is the only definitive treatment for acute cholecystitis, with laparoscopic cholecystectomy (LC) considered the gold standard. Serious complications that may occur with laparoscopic cholecystectomy, including bile duct injury, bile leaks, bleeding, and bowel injury, result in part from the anatomy, disease related pathology and structural misidentification due to inflammatory process (Gupta 2019).
The CADISS® System, Chemically Assisted mechanical DISSection, is intended for the selective detachment of pathological tissue layers and/or fibrotic tissues in various surgical procedures without using cutting instruments. It is based on the property of the drug mesna (Sodium 2-mercaptoethane sulfonate) to cleave the disulfide bonds responsible for the adherence of pathological tissues and for the strength of fibrosis. This study is a prospective, multi-sites, open label, single cohort clinical trial evaluating the use of CADISS® system to facilitate dissection of severe adhesions in cholecystectomy and to allow better identification of different structure.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •≥ 18 years old
- •Weight > 30 kg
- •Confirmed diagnosis of acute gallstone cholecystitis
- •Symptomatic or asymptomatic cholecystitis
- •Under surgery for cholecystectomy:
- •for the 5 first patients : cholecystectomy will take place within 72 hours of the first symptoms of cholecystitis
- •after the 5 first patients : cholecystectomy will be allowed at any time after the first symptoms and at physician judgment
- •Patient agrees to signed the informed consent
Exclusion Criteria
- •< 18 years old
- •Known hypersensibility to mesna
- •Patient taking anticoagulant at the screening visit
- •Patient having a pancreatitis or angiocholitis
- •Patients suffering from hepatic or renal disorders
- •Unable to sign the informed consent
- •Participation in any study involving an investigational drug or device within the past 3 Months.
- •Patient is pregnant, breastfeeding or has wish of pregnancy during the study.
- •Individuals under tutorship or trusteeship
Outcomes
Primary Outcomes
Ability of the CADISS® System to dissect adherences without cutting
Time Frame: Surgery
Percentage of successful dissection
Secondary Outcomes
- Adverse events(Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up)
- The change of bleeding with the use of the CADISS System(Surgery)
- A change of surgical complication risk(Surgery)
- The capability of the CADISS System to highlight the cleavage plane(Surgery)
- The facilitation of detachment with the CADISS System(Surgery)
- The ease of use of the CADISS System(Surgery)
- The easiness of control of the topical application with the CADISS System(Surgery)