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

NCT06491524 | Completed

• 1 other identifier: 2022-R022
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Ureteroscopy; Urolithiasis

Keywords

flexible ureteroscope; ureteral guide sheath

Outcome Measures

Primary Outcomes (1)

• Success rate of Accessing

  success rate of UAS placement (SRUP)

  1 day

Secondary Outcomes (4)

• Evaluation of intraoperative ureteral injury

  1 day

• Stone free rate

  1 and 30 days

• overactive bladder symptom score (OABSS)

  1 month

• Quality of life (QOL) questionnaire

  1 month

Study Arms (1)

7.5Fr flexible ureteroscope combined 10Fr ureteral access sheath

EXPERIMENTAL

Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone \<2cm

Device: Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm

Interventions

Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm DEVICE

Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone \<2cm

7.5Fr flexible ureteroscope combined 10Fr ureteral access sheath

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Patients with a previous history of ureteral stenosis or who have undergone open, laparoscopic ureteral, nephrectomy and lithotripsy;
• 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.

Sponsors & Collaborators

• Ningbo No. 1 Hospital: lead

Study Sites (1)

Ningbo First hospital

Ningbo, Zhejiang, 315010, China

Location

MeSH Terms

Conditions

Urolithiasis

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Li Fang, Doctor

  Urology of NIngbo First Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: July 9, 2024
• Study Start: April 20, 2022
• Primary Completion: October 6, 2023
• Study Completion: October 28, 2023
• Last Updated: July 9, 2024

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)