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

NCT ID: NCT05041686

Last Updated: 2021-09-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-05-30
• Study Completion Date: 2021-02-24

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.

Conditions

Cholecystitis, Acute

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

CADISS® System

Group Type: EXPERIMENTAL

CADISS® System

Intervention Type: COMBINATION_PRODUCT

The CADISS® device was procured from AuXin Surgery. It consists in three elements:

1. 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.

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.

3. 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.

Interventions

CADISS® System

The CADISS® device was procured from AuXin Surgery. It consists in three elements:

1. 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.

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.

3. 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.

Intervention Type: COMBINATION_PRODUCT

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AuXin Surgery SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alphonse Lubansu

Role: PRINCIPAL_INVESTIGATOR

University Hospital Erasme, Brussels, Belgium

Locations

AuXin Surgery

Louvain-la-Neuve, , Belgium

Countries

Belgium

References

Malvaux P, Gherardi D, Gryspeerdt F, De Gheldere C. The utility of the CADISS(R) system in laparoscopic cholecystectomy for acute cholecystitis. Surg Endosc. 2022 Dec;36(12):9462-9468. doi: 10.1007/s00464-022-09616-w. Epub 2022 Nov 1.

Reference Type: DERIVED

PMID: 36319896 (View on PubMed)

Other Identifiers

CADISS1703

Identifier Type: -

Identifier Source: org_study_id