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

Primary Purpose

Cholecystitis, Acute

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
CADISS® System
Sponsored by
AuXin Surgery SA
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Cholecystitis, Acute

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • AuXin Surgery

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

CADISS® System

Arm Description

Outcomes

Primary Outcome Measures

Ability of the CADISS® System to dissect adherences without cutting
Percentage of successful dissection

Secondary Outcome Measures

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
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.
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.
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
The ease of use of the CADISS System
Likert scale - 0 to 10, A score of 0 representing the worse outcome
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
Adverse events
All CADISS® related adverse events will be reported

Full Information

First Posted
September 1, 2021
Last Updated
September 10, 2021
Sponsor
AuXin Surgery SA
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1. Study Identification

Unique Protocol Identification Number
NCT05041686
Brief Title
Usefulness of the CADISS® System for the Cleavage of Severe Adhesions in Cholecystectomy
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Completed
Study Start Date
May 30, 2019 (Actual)
Primary Completion Date
February 24, 2021 (Actual)
Study Completion Date
February 24, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AuXin Surgery SA

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystitis, Acute

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CADISS® System
Arm Type
Experimental
Intervention Type
Combination Product
Intervention Name(s)
CADISS® System
Intervention Description
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.
Primary Outcome Measure Information:
Title
Ability of the CADISS® System to dissect adherences without cutting
Description
Percentage of successful dissection
Time Frame
Surgery
Secondary Outcome Measure Information:
Title
The facilitation of detachment with the CADISS System
Description
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
Time Frame
Surgery
Title
The change of bleeding with the use of the CADISS System
Description
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.
Time Frame
Surgery
Title
A change of surgical complication risk
Description
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.
Time Frame
Surgery
Title
The capability of the CADISS System to highlight the cleavage plane
Description
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
Time Frame
Surgery
Title
The ease of use of the CADISS System
Description
Likert scale - 0 to 10, A score of 0 representing the worse outcome
Time Frame
Surgery
Title
The easiness of control of the topical application with the CADISS System
Description
Likert scale - 0 to 10, A score of 0 representing the worse outcome
Time Frame
Surgery
Title
Adverse events
Description
All CADISS® related adverse events will be reported
Time Frame
Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alphonse Lubansu
Organizational Affiliation
University Hospital Erasme, Brussels, Belgium
Official's Role
Principal Investigator
Facility Information:
Facility Name
AuXin Surgery
City
Louvain-la-Neuve
ZIP/Postal Code
1348
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36319896
Citation
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.
Results Reference
derived

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

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