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

NCT05041686 | Completed

• 1 other identifier: CADISS1703
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Ability of the CADISS® System to dissect adherences without cutting

  Percentage of successful dissection

  Surgery

Secondary Outcomes (7)

• The facilitation of detachment with the CADISS System

  Surgery

• 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 ease of use of the CADISS System

  Surgery

Study Arms (1)

CADISS® System

EXPERIMENTAL

Combination Product: CADISS® System

Interventions

CADISS® System 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.

CADISS® System

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 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

You may not qualify if:

• \< 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

Sponsors & Collaborators

• AuXin Surgery SA: lead

Study Sites (1)

AuXin Surgery

Louvain-la-Neuve, 1348, Belgium

Location

Related Publications (1)

• 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.

  PMID: 36319896 DERIVED

MeSH Terms

Conditions

Cholecystitis, Acute

Condition Hierarchy (Ancestors)

Cholecystitis; Gallbladder Diseases; Biliary Tract Diseases; Digestive System Diseases

Study Officials

• Alphonse Lubansu

  University Hospital Erasme, Brussels, Belgium

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2021
• First Posted: September 13, 2021
• Study Start: May 30, 2019
• Primary Completion: February 24, 2021
• Study Completion: February 24, 2021
• Last Updated: September 13, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)