Disposable 7.5Fr Electronic Flexible Ureteroscope Combined 10Fr Ureteral Access Sheath for Treatment of Renal Stone <2cm

Not Applicable

Completed

• Conditions: Ureteroscopy; Urolithiasis
• Interventions: Device: Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm

• Registration Number: NCT06491524
• Lead Sponsor: Ningbo No. 1 Hospital

Brief Summary

Observation efficacy and safety of disposable f7.5 electronic flexible ureteroscope combined f10 ureteral guide sheath for treatment of renal stone \<2cm.

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 Timeline

• Study Start: 2022-04-20
• Study First Submitted: 2022-11-23
• Status Verified: 2022-12
• Primary Completion: 2023-10-06
• Study Completion: 2023-10-28
• Study First Submitted QC: 2024-07-08
• Last Update Submitted: 2024-07-08
• Study First Posted: 2024-07-09
• Last Update Posted: 2024-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

1. Patients with kidney stones less than 2cm who choose to perform "Flexible ureteroscopic holmium laser lithotripsy";
2. Over 18 years old, male or female;
3. No hydronephrosis or mild to moderate hydronephrosis (collection system separation is less than 2cm);
4. 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;
5. No urinary tract infection or no clinical manifestations of urinary tract infection;
6. 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

1. Patients with a previous history of ureteral stenosis or who have undergone open, laparoscopic ureteral, nephrectomy and lithotripsy;
2. Fever or urinary tract infection is not treated according to the inclusion criteira;
3. Pregnant women and women's menstrual periods;
4. Cannot tolerate anaesthesia or surgery due to serious systemic diseases, heart disease, lung insufficiency and failure of important organs;
5. Anatomical malformations such as polycystic kidneys, horseshoe kidneys, and ectopic kidneys;
6. Patients with high suspicion of ureteral stenosis or diseases that are considered unsuitable to participate in this clinical study;
7. Patients indwelling double J stent preoperatively;
8. Patients who need bilateral upper urinary tract surgery at the same time.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
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

Primary Outcome Measures

Name	Time	Method
Success rate of Accessing	1 day	success rate of UAS placement (SRUP)

Secondary Outcome Measures

Name	Time	Method
overactive bladder symptom score (OABSS)	1 month	Overactive bladder symptom score (OABSS) before and after the operation
Quality of life (QOL) questionnaire	1 month	Quality of life (QOL) before and after the operation
Evaluation of intraoperative ureteral injury	1 day	Evaluation of intraoperative ureteral injury according to the standards proposed by Traxer et. al.
Stone free rate	1 and 30 days	stone free rate (SFR)

Trial Locations

Locations (1)

Ningbo First hospital; 🇨🇳 Ningbo, Zhejiang, China