Cholecystitis, AcuteNCT05041686
Usefulness of the CADISS® System for the Cleavage of Severe Adhesions in Cholecystectomy
A study testing CADISS® System in people with Cholecystitis, Acute, run by AuXin Surgery SA at 1 site in Belgium.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cholecystitis, Acute
- What is being tested?
- CADISS® System
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteBelgium
- Study dates
- 30 May 2019to 24 Feb 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥ 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
Who cannot join
- < 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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)
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
- Being tested
- CADISS® System
- Medical subject headings
- Cholecystitis, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CADISS® SystemCombination product
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.
| Study group | Role | What they receive |
|---|---|---|
| CADISS® System | Experimental | Not described Receives: Combination Product: CADISS® System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ability of the CADISS® System to dissect adherences without cutting
Percentage of successful dissection
Measured: Surgery
Secondary outcomes (7)
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
Measured: 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.
Measured: 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.
Measured: 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
Measured: Surgery
The ease of use of the CADISS System
Likert scale - 0 to 10, A score of 0 representing the worse outcome
Measured: 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
Measured: Surgery
Adverse events
All CADISS® related adverse events will be reported
Measured: Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2021
- Study start30 May 2019
- Primary completion24 Feb 2021
- Study completion24 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cholecystitis, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- AuXin Surgery SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Alphonse Lubansu, Principal investigator, University Hospital Erasme, Brussels, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05041686
- Sponsor's protocol ID
- CADISS1703
- Status last verified
- Aug 2021
- First submitted
- 1 Sep 2021
- Last updated
- 13 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 36319896
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT05041686
- Acronym / sponsor ID
- CADISS1703
- Conditions
- Cholecystitis, Acute
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- AuXin Surgery SAIndustry (pharma, biotech, devices)
- Study start
- 30 May 2019 (actual)
- Primary completion
- 24 Feb 2021 (actual)
- Study completion
- 24 Feb 2021 (actual)
- First posted
- 13 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CADISS® System | Experimental | Combination Product: CADISS® System |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- ≥ 18 years old
- Weight > 30 kg
- Confirmed diagnosis of acute gallstone cholecystitis
- Symptomatic or asymptomatic cholecystitis
- Under surgery for cholecystectomy:
Key exclusion criteria (10 listed)
- < 18 years old
- ≤ 30 kg
- Known hypersensibility to mesna
- Patient taking anticoagulant at the screening visit
- Patient having a pancreatitis or angiocholitis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CADISS® SystemThe 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. | Combination product | CADISS® System |
Primary outcome
Ability of the CADISS® System to dissect adherences without cutting
Time frame: Surgery
Percentage of successful dissection
7 secondary outcomes
The facilitation of detachment with the CADISS System
Time frame: Surgery
The change of bleeding with the use of the CADISS System
Time frame: Surgery
A change of surgical complication risk
Time frame: Surgery
The capability of the CADISS System to highlight the cleavage plane
Time frame: Surgery
The ease of use of the CADISS System
Time frame: Surgery
The easiness of control of the topical application with the CADISS System
Time frame: Surgery
Adverse events
Time frame: Surgery, 2 to 5 days after surgery (Hospital discharge), 6 weeks follow-up
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2021.
- Derived from this study: PubMed 36319896Malvaux 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alphonse Lubansu principal investigator
University Hospital Erasme, Brussels, Belgium
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CADISS® System in people with Cholecystitis, Acute, run by AuXin Surgery SA at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Ability of the CADISS® System to dissect adherences without cutting (time frame: Surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05041686, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2021.