Usefulness of the CADISS® System for the Cleavage of Severe Adhesions in Cholecystectomy

Study Overview
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Brief Summary
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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.

Official Title
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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)

Conditions
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Cholecystitis, Acute

Intervention / Treatment
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* Combination Product: CADISS® System


Participation Criteria
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Eligibility Criteria
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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 ≤ 30 kg 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CADISS® System<br> | Combination Product: CADISS® System<br>* The CADISS® device was procured from AuXin Surgery. It consists in three elements: A single use disposable Remote Kit, containing a sterile cartridge, which prepares the Drug Product immediately before use, and the sterile tubing for fluid connexion. The Drug Product is a 30 ml sterile 5% mesna solution of pH 7.3+/-0.5 2. Reusable stainless steel noncutting mechanical instruments similar to those used in the normal practice, except for the provision of an internal irrigation channel bringing the Drug Product at the working edge. A pedal controlled electric motor driving the peristaltic cassette included in the disposable tubing in order to control the dispensing of the Drug Product during the procedure.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability of the CADISS® System to dissect adherences without cutting | Percentage of successful dissection | Surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The facilitation of detachment with the CADISS System | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice | Surgery | 
| The change of bleeding with the use of the CADISS System | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means the use of CADISS System reduction reduce bleeding compared to the current practice. | Surgery | 
| A change of surgical complication risk | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means the use of the CADISS System reduce the risk of surgical complication risks compared to the current practice. | Surgery | 
| The capability of the CADISS System to highlight the cleavage plane | Likert scale - 0 to 10, the parameter is evaluated in comparison to the current surgeon practice. A score of 5 representing an appreciation of equivalence for the parameter with the current practice. A score above 5 means an improvement compared to the current practice | Surgery | 
| The ease of use of the CADISS System | Likert scale - 0 to 10, A score of 0 representing the worse outcome | Surgery | 
| The easiness of control of the topical application with the CADISS System | Likert scale - 0 to 10, A score of 0 representing the worse outcome | Surgery | 
| Adverse events | All CADISS® related adverse events will be reported | Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up |