Disposable 7.5Fr Electronic Flexible Ureteroscope Combined 10Fr Ureteral Access Sheath for Treatment of Renal Stone <2cm
July 8, 2024 updated by: Ningbo No. 1 Hospital
Observation efficacy and safety of disposable f7.5 electronic flexible ureteroscope combined f10 ureteral guide sheath for treatment of renal stone <2cm.
Study Overview
Status
Completed
Conditions
Detailed Description
Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral guide sheath to treat renal stone <2cm, and investigating its efficacy and safety.
Study Type
Interventional
Enrollment (Actual)
23
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 Locations
-
-
Zhejiang
-
Ningbo, Zhejiang, China, 315010
- Ningbo First Hospital
-
-
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:
- Patients with kidney stones less than 2cm who choose to perform "Flexible ureteroscopic holmium laser lithotripsy";
- Over 18 years old, male or female;
- No hydronephrosis or mild to moderate hydronephrosis (collection system separation is less than 2cm);
- The subject has no mental illness or language dysfunction, can understand the situation of this study and has signed an informed consent form, and is estimated to be able to cooperate with the completion of the entire study;
- No urinary tract infection or no clinical manifestations of urinary tract infection;
- Patients with urinary tract infection, negative urine culture, and no fever need to undergo antibiotic treatment for more than 3 days; urinary routine examination suggests urinary tract infection, positive urine culture, and patients without fever need to undergo antibiotic treatment for more than 7 days, till the urine culture turns negative.
Exclusion Criteria:
- Patients with a previous history of ureteral stenosis or who have undergone open, laparoscopic ureteral, nephrectomy and lithotripsy;
- Fever or urinary tract infection is not treated according to the inclusion criteira;
- Pregnant women and women's menstrual periods;
- Cannot tolerate anaesthesia or surgery due to serious systemic diseases, heart disease, lung insufficiency and failure of important organs;
- Anatomical malformations such as polycystic kidneys, horseshoe kidneys, and ectopic kidneys;
- Patients with high suspicion of ureteral stenosis or diseases that are considered unsuitable to participate in this clinical study;
- Patients indwelling double J stent preoperatively;
- Patients who need bilateral upper urinary tract surgery at the same time.
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: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: 7.5Fr flexible ureteroscope combined 10Fr ureteral access sheath
Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm
|
Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Success rate of Accessing
Time Frame: 1 day
|
success rate of UAS placement (SRUP)
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of intraoperative ureteral injury
Time Frame: 1 day
|
Evaluation of intraoperative ureteral injury according to the standards proposed by Traxer et.
al.
|
1 day
|
|
Stone free rate
Time Frame: 1 and 30 days
|
stone free rate (SFR)
|
1 and 30 days
|
|
overactive bladder symptom score (OABSS)
Time Frame: 1 month
|
Overactive bladder symptom score (OABSS) before and after the operation
|
1 month
|
|
Quality of life (QOL) questionnaire
Time Frame: 1 month
|
Quality of life (QOL) before and after the operation
|
1 month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Li Fang, Doctor, Urology of NIngbo First Hospital
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 20, 2022
Primary Completion (Actual)
October 6, 2023
Study Completion (Actual)
October 28, 2023
Study Registration Dates
First Submitted
November 23, 2022
First Submitted That Met QC Criteria
July 8, 2024
First Posted (Actual)
July 9, 2024
Study Record Updates
Last Update Posted (Actual)
July 9, 2024
Last Update Submitted That Met QC Criteria
July 8, 2024
Last Verified
December 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2022-R022
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
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.