UreteroscopyNCT06491524
Disposable 7.5Fr Electronic Flexible Ureteroscope Combined 10Fr Ureteral Access Sheath for Treatment of Renal Stone <2cm
A study testing Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm in people with Ureteroscopy and Urolithiasis, run by Ningbo No. 1 Hospital at 1 site in China.
Trial summary
Observation efficacy and safety of disposable f7.5 electronic flexible ureteroscope combined f10 ureteral guide sheath for treatment of renal stone <2cm. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureteroscopy, Urolithiasis
- What is being tested?
- Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2022to 28 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Observation efficacy and safety of disposable f7.5 electronic flexible ureteroscope combined f10 ureteral guide sheath for treatment of renal stone <2cm.
Read the 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.
- Conditions
- Ureteroscopy, Urolithiasis
- Being tested
- Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm
- Keywords
- flexible ureteroscope, ureteral guide sheath
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cmDevice
Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of Accessing
success rate of UAS placement (SRUP)
Measured: 1 day
Secondary outcomes (4)
Evaluation of intraoperative ureteral injury
Evaluation of intraoperative ureteral injury according to the standards proposed by Traxer et. al.
Measured: 1 day
Stone free rate
stone free rate (SFR)
Measured: 1 and 30 days
overactive bladder symptom score (OABSS)
Overactive bladder symptom score (OABSS) before and after the operation
Measured: 1 month
Quality of life (QOL) questionnaire
Quality of life (QOL) before and after the operation
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start20 Apr 2022
- Primary completion6 Oct 2023
- Study completion28 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UreteroscopyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ningbo No. 1 Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Li Fang, Doctor, Principal investigator, Urology of NIngbo First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491524
- Sponsor's protocol ID
- 2022-R022
- Status last verified
- Dec 2022
- First submitted
- 23 Nov 2022
- Last updated
- 9 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disposable 7.5Fr Electronic Flexible Ureteroscope Combined 10Fr Ureteral Access Sheath for Treatment of Renal Stone <2cm
- ClinicalTrials.gov ID
- NCT06491524
- Acronym / sponsor ID
- 2022-R022
- Conditions
- Ureteroscopy, Urolithiasis
- Keywords
- flexible ureteroscope, ureteral guide sheath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Ningbo No. 1 HospitalUniversity, hospital or other
- Study start
- 20 Apr 2022 (actual)
- Primary completion
- 6 Oct 2023 (actual)
- Study completion
- 28 Oct 2023 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 7.5Fr flexible ureteroscope combined 10Fr ureteral access sheath | Experimental | Device: Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cmUsing disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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;
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cmUsing disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm | Device | 7.5Fr flexible ureteroscope combined 10Fr ureteral access sheath |
Primary outcome
Success rate of Accessing
Time frame: 1 day
success rate of UAS placement (SRUP)
4 secondary outcomes
Evaluation of intraoperative ureteral injury
Time frame: 1 day
Stone free rate
Time frame: 1 and 30 days
overactive bladder symptom score (OABSS)
Time frame: 1 month
Quality of life (QOL) questionnaire
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2024.
- Individual participant dataSharing planned: No
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Stone Clearance With Aspiration vs Other Technologies: a Real-world Evidence Study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Li Fang, Doctor principal investigator
Urology of NIngbo First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Using disposable 7.5Fr electronic flexible ureteroscope combined 10Fr ureteral access sheath to treat renal stone <2cm in people with Ureteroscopy and Urolithiasis, run by Ningbo No. 1 Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of Accessing (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jul 2024.