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Completed

NCT Number: NCT06491524

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

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

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ningbo First hospital

Ningbo, Zhejiang, 315010, China

About this study

Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral guide sheath to treat renal stone <2cm, and investigating its efficacy and safety.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Primary outcomes

  1. Success rate of Accessing

    Time frame: 1 day

    success rate of UAS placement (SRUP)

Secondary outcomes

  1. Evaluation of intraoperative ureteral injury

    Time frame: 1 day

    Evaluation of intraoperative ureteral injury according to the standards proposed by Traxer et. al.

  2. Stone free rate

    Time frame: 1 and 30 days

    stone free rate (SFR)

  3. overactive bladder symptom score (OABSS)

    Time frame: 1 month

    Overactive bladder symptom score (OABSS) before and after the operation

  4. Quality of life (QOL) questionnaire

    Time frame: 1 month

    Quality of life (QOL) before and after the operation

Sponsors and collaborators

Lead sponsor

Ningbo No. 1 Hospital

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 9, 2024
Registry last updated
Jul 9, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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