UrolithiasisNCT03220516
Single-use Digital Flexible Ureteroscope vs Nondisposable Fiber Optic vs Digital Ureteroscope
A study testing single use digital ureteroscope, reusable fiberoptic ureteroscope and reusable digital flexible ureteroscope in people with Urolithiasis, run by Guohua Zeng.
Trial summary
The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Urolithiasis
- What is being tested?
- single use digital ureteroscope, reusable fiberoptic ureteroscope and reusable digital flexible ureteroscope
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Aug 2017to Sep 2020
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-70 years
- American society of Anesthesiology (ASA) score 1 and 2
- Renal or upper ureteral stone of diameter ≤ 2.0 cm
Who cannot join
- Ureteral stricture, renal or ureteral deformity
- Pregnancy
- Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Prospective Randomized Study Comparing Single-use Digital Flexible Ureteroscope, Nondisposable Fiber Optic and Digital Ureteroscope in Treatment of Upper Urinary Stone Less Than 2 cm
The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.
Read the detailed description
With the advancement of technology, flexible ureteroscopy (f-URS) has become an attractive option for surgical management of kidney stones. However, the durability of flexible ureteroscope still remains a major concern. Due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining fURS programs worldwide, especially in the developing countries. Nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.
- Conditions
- Urolithiasis
- Being tested
- single use digital ureteroscope, reusable fiberoptic ureteroscope, reusable digital flexible ureteroscope
- Medical subject headings
- Urolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
single use digital ureteroscopeProcedure or surgery
All participants in this arm will undergo RIRS using a single use digital ureteroscope.
reusable fiberoptic ureteroscopeProcedure or surgery
All participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope
reusable digital flexible ureteroscopeProcedure or surgery
All participants under this arm will undergo RIRS using reusable digital flexible ureteroscope
| Study group | Role | What they receive |
|---|---|---|
| single-use digital ureteroscope | Experimental | Participants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope. Receives: Procedure: single use digital ureteroscope |
| reusable fiberoptic ureteroscopes | Experimental | Participants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope Receives: Procedure: reusable fiberoptic ureteroscope |
| reusable digital flexible ureteroscopes | Experimental | Participants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope. Receives: Procedure: reusable digital flexible ureteroscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
cost of surgery
the total cost of the procedure
Measured: intraoperative
Secondary outcomes (5)
Stone free rate
Measured: 1month after surgery
stone free rate
Measured: 3months after surgery
complication rates
Measured: upto 3months
operative time
Measured: intraoperative
operator's satisfaction with the scope
on the scope or 1-10
Measured: intraoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study startAug 2017 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionSep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UrolithiasisStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guohua Zeng
- Sponsor type
- University, hospital or other
- Collaborators
- Dr. Lutfi Kirdar Kartal Training and Research Hospital, Siloam St.Trudpert Hospital
- Responsible party
- Sponsor-investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220516
- Sponsor's protocol ID
- Scopes compared
- Status last verified
- Jul 2017
- First submitted
- 1 Jul 2017
- Last updated
- 18 Jul 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Randomized Study Comparing Single-use Digital Flexible Ureteroscope, Nondisposable Fiber Optic and Digital Ureteroscope in Treatment of Upper Urinary Stone Less Than 2 cm
- ClinicalTrials.gov ID
- NCT03220516
- Acronym / sponsor ID
- Scopes compared
- Conditions
- Urolithiasis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Guohua ZengUniversity, hospital or other
- Collaborators
- Dr. Lutfi Kirdar Kartal Training and Research Hospital, Siloam St.Trudpert Hospital
- Study start
- Aug 2017 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- Sep 2020 (estimated)
- First posted
- 18 Jul 2017 (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.
The aim of this trial is to compare the safety, efficacy and cost effectiveness of the three types of scopes.
Detailed description
With the advancement of technology, flexible ureteroscopy (f-URS) has become an attractive option for surgical management of kidney stones. However, the durability of flexible ureteroscope still remains a major concern. Due to the high cost and limited durability, the cost-benefit of non-disposable flexible ureteroscope continues to be the most important factor for initiating and maintaining fURS programs worldwide, especially in the developing countries. Nowadays, disposable digital flexible ureteroscopes are available, offering an improved image resolution, no need for sterilization and repair, and more economic.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| single-use digital ureteroscope | Experimental | Procedure: single use digital ureteroscopeParticipants under this arm will undergo retrograde intrarenal surgery (RIRS) procedure under the single use digital ureteroscope. |
| reusable fiberoptic ureteroscopes | Experimental | Procedure: reusable fiberoptic ureteroscopeParticipants under this arm will undergo the RIRS procedure under the reusable fiberoptic ureteroscope |
| reusable digital flexible ureteroscopes | Experimental | Procedure: reusable digital flexible ureteroscopeParticipants under this arm will undergo the RIRS procedure under the reusable digital flexible ureteroscope. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged 18-70 years
- American society of Anesthesiology (ASA) score 1 and 2
- Renal or upper ureteral stone of diameter ≤ 2.0 cm
Key exclusion criteria (3 listed)
- Ureteral stricture, renal or ureteral deformity
- Pregnancy
- Patients with chronic kidney disease, CKD (serum creatine> 177 umol/L)
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 |
|---|---|---|
| single use digital ureteroscopeAll participants in this arm will undergo RIRS using a single use digital ureteroscope. | Procedure or surgery | single-use digital ureteroscope |
| reusable fiberoptic ureteroscopeAll participants under this arm will undergo RIRS using a reusable fiberoptic ureteroscope | Procedure or surgery | reusable fiberoptic ureteroscopes |
| reusable digital flexible ureteroscopeAll participants under this arm will undergo RIRS using reusable digital flexible ureteroscope | Procedure or surgery | reusable digital flexible ureteroscopes |
Primary outcome
cost of surgery
Time frame: intraoperative
the total cost of the procedure
5 secondary outcomes
Stone free rate
Time frame: 1month after surgery
stone free rate
Time frame: 3months after surgery
complication rates
Time frame: upto 3months
operative time
Time frame: intraoperative
operator's satisfaction with the scope
Time frame: intraoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2017.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing single use digital ureteroscope, reusable fiberoptic ureteroscope and reusable digital flexible ureteroscope in people with Urolithiasis, run by Guohua Zeng.
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 3 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 18 Jul 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Zhu, PhD (008613622754991, doczw1989@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
cost of surgery (time frame: intraoperative). 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 18 Jul 2017.