- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06815107
Risk Factors for Poor Tolerance of Ureteral Double-J Stent (ToleJJ)
February 4, 2025 updated by: Centre Hospitalier Universitaire, Amiens
The placement of a Ureteral Double-J Stent as an emergency treatment or preparation for endoscopy after Colic nephritis is very frequent.
It is often poorly supported, most often by young patients.
A rich symptomatology is related to the probe responsible for a limitation of activities that can have a strong socio-economic impact.
The objective of this study is the identification of the predictive factors of poor tolerance.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Philippe De Sousa, MD
- Phone Number: 33+322455775
- Email: desousa.philippe@chu-amiens.fr
Study Locations
-
-
-
Amiens, France, 80054
- Recruiting
- CHU Amiens-Picardie
-
Contact:
- Philippe De Sousa, MD
- Phone Number: 33+322455775
- Email: desousa.philippe@chu-amiens.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- patient over 18 years old
- patient who need Ureteral Double-J Stenting
Exclusion Criteria:
- patient under 18 years old,
- Iterative change,
- understanding disorder,
- inability to answer the questionnaire,
- refusal of the patient,
- long-term Ureteral Double-J Stenting (more than 6 month),
- active cancer.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
tolerance score of Ureteral Double-J Stent
Time Frame: day 15
|
A tolerance score of Ureteral Double-J Stent will be established using the USSQ questionnaire allowing the comparison of the symptomatology with and after ablation of the stent
|
day 15
|
|
tolerance score of Ureteral Double-J Stent
Time Frame: 3 months
|
A tolerance score of Ureteral Double-J Stent will be established using the USSQ questionnaire allowing the comparison of the symptomatology with and after ablation of the stent
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 15, 2020
Primary Completion (Actual)
April 15, 2021
Study Completion (Estimated)
April 1, 2026
Study Registration Dates
First Submitted
February 4, 2025
First Submitted That Met QC Criteria
February 4, 2025
First Posted (Actual)
March 25, 2025
Study Record Updates
Last Update Posted (Actual)
March 25, 2025
Last Update Submitted That Met QC Criteria
February 4, 2025
Last Verified
January 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- PI2020_843_0029
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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