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

Cholecystitis, Acute Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05041686
• Other study ID #: CADISS1703
• Status: Completed
• Phase: N/A
• Start date: May 30, 2019
• Est. completion date: February 24, 2021

Study information

• Verified date: August 2021
• Source: AuXin Surgery SA
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 24, 2021
• Est. primary completion date: February 24, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cholecystitis
• Cholecystitis, Acute

Intervention

Combination Product:
• CADISS® System
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.

Locations

Country	Name	City	State
Belgium	AuXin Surgery	Louvain-la-Neuve

Sponsors (1)

Lead Sponsor	Collaborator
AuXin Surgery SA

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ability of the CADISS® System to dissect adherences without cutting	Percentage of successful dissection	Surgery
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The ease of use of the CADISS System	Likert scale - 0 to 10, A score of 0 representing the worse outcome	Surgery
Secondary	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
Secondary	Adverse events	All CADISS® related adverse events will be reported	Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up