Comparative study of encrustation and bacterial colonization of ureteral stents with anti adhesive and bacteria repelling coating versus uncoated stents
Organizational Data
- DRKS-ID:
- DRKS00025298
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2021-10-21
- Last update in DRKS:
- 2023-12-19
- Registration type:
- Prospective
Acronym/abbreviation of the study
CLEANUS
URL of the study
Brief summary in lay language
Ureteral stents are often affected by biofilm formation, the growth of bacteria on the surface and encrustation, the deposition of mineral crystals onto the surface and lumen of a ureteral stent. This can create serious problems, like blockage of the ureteral stent making an emergency stent removal necessary. Ureteral stents are made from various materials, but the tendency to encrust is very similar for all of them. UroNova has developed a new coating for double J ureteral stents with bacteria repelling and encrustation suppressing properties. Goal of the study is to analyze the efficacy and advantages of the new coated ureteral stent compared to conventional ureteral stents.
Brief summary in scientific language
Biofilm formation and encrustation are the most common complications in the use of ureteral double J stents. Patients being affected by a blockage of the ureteral stent need an emergency stent removal. Ureteral stents are made from various materials, but the tendency to encrust is very similar for all of them. UroNova has developed a new coating for double J ureteral stents with bacteria repelling and encrustation suppressing properties. The coating is long-term stable, no drug elution takes place. No pharmacological agents or biocide components are used in the coating. Goal of the study is to analyze the efficacy of the new coated ureteral stent compared to conventional ureteral stents in terms of the amount of encrustation and quality of life.
Health condition or problem studied
- ICD10:
- N20 - Calculus of kidney and ureter
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- Uncoated ureteral stent
- Arm 2:
- Coated ureteral stent
Endpoints
- Primary outcome:
- Measurement of the weight of encrustation after 30 days indwelling time
- Secondary outcome:
- Evaluation of the grade of ureteral stent symptoms 7 days after insertion and 7 days after removal
Study Design
- Purpose:
- Treatment
- Allocation:
- Randomized controlled study
- Control:
-
- Other
- Phase:
- III
- Study type:
- Interventional
- Mechanism of allocation concealment:
- Block randomization
- Blinding:
- Yes
- Assignment:
- Parallel
- Sequence generation:
- No Entry
- Who is blinded:
-
- Assessor
- Caregiver
- Data analyst
- Investigator/therapist
- Patient/subject
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Multicenter study
- Recruitment location(s):
-
- University medical center Universitätsmedizin Rostock, Urologische Klinik und Poliklinik Rostock
- University medical center Paracelsus Medizinische Privatuniversität, Klinikum Nürnberg Nürnberg
Recruitment period and number of participants
- Planned study start date:
- 2022-01-12
- Actual study start date:
- 2022-01-12
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 300
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- no maximum age
- Additional Inclusion Criteria:
- Patients with renal colic that cannot be controlled with medication, severe obstruction with consecutive urinary congestion and / or increasing retention values in accordance with the S2k guideline for diagnosis, therapy and metaphylaxis of urolithiasis. After complicated procedures using ureterorenoscopy, in the case of residual fragments or complications that require treatment In the case of Steinstrasse and fever / urinary tract infection (accumulation of stone fragments in the ureter, which do not pass spontaneously and / or block urine transport) Age:> 18 years Written declaration of consent available
Exclusion Criteria
Patients for whom a ureteral stent cannot be used due to the anatomical conditions. Insufficient mental, linguistic, or physical ability to participate in the study. ECOG> 3 (Eastern Co-operative of Oncology Group) Refusal to participate in the clinical trial. Planned long-term supply or foreseeable long indwelling time of the ureteral stent (> 30 days). Participation in another clinical trial within the last 30 days. Patients who are pregnant or breastfeeding.
Addresses
Primary Sponsor
- Address:
- UroNova GmbH medizinische ImplantateAhornweg 1891083 BaiersdorfGermany
- Telephone:
- +49 9133 8432562
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uronova.com
- Investigator Sponsored/Initiated Trial (IST/IIT):
- No
Contact for Scientific Queries
- Address:
- Urologische Klinik und Poliklinik Universitätsmedizin RostockProf. Dr. med. Oliver HakenbergSchillingallee 3518057 RostockGermany
- Telephone:
- 0381 4947801
- Fax:
- 0381 4947802
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-rostock.de
Contact for Public Queries
- Address:
- Urologische Klinik und Poliklinik Universitätsmedizin RostockProf. Dr. med. Oliver HakenbergSchillingallee 3518057 RostockGermany
- Telephone:
- 0381 4947801
- Fax:
- 0381 4947802
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-rostock.de
Principal Investigator
- Address:
- Urologische Klinik und Poliklinik Universitätsmedizin RostockProf. Dr. med. Oliver HakenbergSchillingallee 3518057 RostockGermany
- Telephone:
- 0381 4947801
- Fax:
- 0381 4947802
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.med.uni-rostock.de
Sources of Monetary or Material Support
Commercial (pharmaceutical industry, medical engineering industry, etc.)
- Address:
- UroNova GmbH medizinische ImplantateAhornweg 1891083 BaiersdorfGermany
- Telephone:
- +49 9133 8432562
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uronova.com
Ethics Committee
Address Ethics Committee
- Address:
- Ethikkommission an der Medizinischen Fakultät der Universität Rostock im Institut für RechtsmedizinSt.-Georg-Str. 10818055 RostockGermany
- Telephone:
- +49-381-4949904
- Fax:
- +49-381-4949902
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2020-12-28
- Ethics committee number:
- FK-2021-0003
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2021-03-01
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No
- IPD Sharing Plan:
- /
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry