Kidney StoneNCT05952635
Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery
A study testing Tip bendable suction ureteral access sheath in people with Kidney Stone, run by The First Affiliated Hospital of Guangzhou Medical University at 1 site in China.
Trial summary
Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world[1,2]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Stone
- What is being tested?
- Tip bendable suction ureteral access sheath
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 320 participants
- Where
- 1 siteChina
- Study dates
- 2 Aug 2023to 21 Jun 2024
- 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
- Adults aged ≥ 18 years;
- American Society of Anesthesiology score 1-3;
- Upper urinary stone (kidney stone or upper ureteral stone) diameter of ≤ 3 cm confirmed by CT;
- Capable of giving written informed consent, which includes adherence with the requirements of the trial.
Who cannot join
- Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit);
- Patients with uncontrolled UTI;
- Patients with health or other factors that are absolute contraindications to RIRS;
- Patients unable to understand or complete trial documentation.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Urology, The First Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510230
About this study
Official title: Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery (RIRS): Study Protocol of a Multicentre, Prospective, Single-blinded, Randomized Controlled Trial
Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world[1,2]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. The development of ureteral access sheath (UAS) is a significant advance in flexible ureteroscopic management of urinary stones. The UAS has two major advantages: 1) facilitating multiple entries into the renal collecting system without causing recurrent trauma to the ureter and permit expeditious basketing of multiple stone fragments, 2) improving the irrigation with better fluid outflow, thereby reducing the renal pelvic pressure (RPP) and risk of infectious complications.
The tip bendable suction ureteral access sheath (S-UAS) is a novel UAS that has good flexibility and deformability at the tip, which can passively bend (bend >90°) with the bending of f-URS and can connect to a vacuum suction device. Preliminary study showed that S-UAS can follow f-URS to cross the UPJ and into the renal pelvis and calices. S-UAS close to the stone can achieve complete stone-free status in RIRS. However, further clinical studies and comparisons with available techniques are required. This prospective, single-blinded, single-center, randomized control trial will evaluate the stone free rates, operative time, postoperative complications following RIRS with S-UAS. To the best of our knowledge, this is the first study to compare the clinical benefits of RIRS with S-UAS and traditional UAS.
- Conditions
- Kidney Stone
- Being tested
- Tip bendable suction ureteral access sheath
- Keywords
- Kidney stone, Flexible ureteroscopy, Ureteral access sheath
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tip bendable suction ureteral access sheathProcedure or surgery
Patient use tip bendable suction ureteral access sheath during flexible ureteroscopy to see if flexible ureteroscopy with S-UAS offers the better treatment outcomes in terms of clinical effectiveness and post-operative complications.
| Study group | Role | What they receive |
|---|---|---|
| Tip bendable suction ureteral access sheath (S-UAS) group | Experimental | Patients will use S-UAS during flexible ureteroscopy. Receives: Procedure: Tip bendable suction ureteral access sheath |
| Traditional ureteral access sheath group | No intervention | Patients will use traditional UAS during flexible ureteroscopy. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate stone-free rate
No residual stone, or no stone fragments larger than 2 mm on KUB and ultrasound at postoperative day 1 are defined as stone free.
Measured: Postoperative day 1
Secondary outcomes (6)
Stone-free rate at 3 months
No residual stone, or no stone fragments larger than 2 mm on CT scan at postoperative 3 month are defined as stone free.
Measured: Postoperative 3 month
Duration of hospital stay
Measured: From date of operation until the date of discharge, assessed up to 2 weeks.
Further interventions received up to 3 months post randomization
Measured: Postoperative 3 month
Complications up to 3 months post randomization
Measured: Postoperative 3 month
Change of Quality of life Score (prior to surgery and at month 3 after randomization)
Measured: Postoperative 3 month
Operative time
The duration from the insertion of the endoscope into the urethra to the completion of stent placement.
Measured: From start of operation until the end of operation, assessed up to 2 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2023
- Study start2 Aug 2023
- Primary completion28 Feb 2024
- Study completion21 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney StoneStudies of the same condition, open and under way.
- More trials run by The First Affiliated Hospital of Guangzhou Medical UniversityThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 320 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xiangya Hospital of Central South University, Xinchang County Hospital of Traditional Chinese Medicine, Prof. Dr. Ilhan Varank Education and Training Hospital, Jose R. Reyes Memorial Medical Center, Guizhou Provincial People's Hospital, University of Malaya
- Responsible party
- Principal investigator, Guohua Zeng, The First Affiliated Hospital of Guangzhou Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05952635
- Sponsor's protocol ID
- MRER2023-001
- Status last verified
- Jun 2024
- First submitted
- 17 Jun 2023
- Last updated
- 25 Jun 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug.
PubMed 39070176
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tip Bendable Suction Ureteral Access Sheath vs. Traditional Ureteral Access Sheath in Retrograde Intrarenal Stone Surgery (RIRS): Study Protocol of a Multicentre, Prospective, Single-blinded, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05952635
- Acronym / sponsor ID
- MRER2023-001
- Conditions
- Kidney Stone
- Keywords
- Kidney stone, Flexible ureteroscopy, Ureteral access sheath
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 320 participants (actual)
- Lead sponsor
- The First Affiliated Hospital of Guangzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Xiangya Hospital of Central South University, Xinchang County Hospital of Traditional Chinese Medicine, Prof. Dr. Ilhan Varank Education and Training Hospital, Jose R. Reyes Memorial Medical Center, Guizhou Provincial People's Hospital, University of Malaya
- Study start
- 2 Aug 2023 (actual)
- Primary completion
- 28 Feb 2024 (actual)
- Study completion
- 21 Jun 2024 (actual)
- First posted
- 19 Jul 2023 (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.
Nephrolithiasis is the most common chronic kidney condition and affecting approximately one in every 10-17 people in the world[1,2]. Flexible ureteroscopy (f-URS) has become one of the most common treatments for ureteral and renal stones with minimal complications. The development of ureteral access sheath (UAS) is a significant advance in flexible ureteroscopic management of urinary stones. The UAS has two major advantages: 1) facilitating multiple entries into the renal collecting system without causing recurrent trauma to the ureter and permit expeditious basketing of multiple stone fragments, 2) improving the irrigation with better fluid outflow, thereby reducing the renal pelvic pressure (RPP) and risk of infectious complications.
The tip bendable suction ureteral access sheath (S-UAS) is a novel UAS that has good flexibility and deformability at the tip, which can passively bend (bend >90°) with the bending of f-URS and can connect to a vacuum suction device. Preliminary study showed that S-UAS can follow f-URS to cross the UPJ and into the renal pelvis and calices. S-UAS close to the stone can achieve complete stone-free status in RIRS. However, further clinical studies and comparisons with available techniques are required. This prospective, single-blinded, single-center, randomized control trial will evaluate the stone free rates, operative time, postoperative complications following RIRS with S-UAS. To the best of our knowledge, this is the first study to compare the clinical benefits of RIRS with S-UAS and traditional UAS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tip bendable suction ureteral access sheath (S-UAS) group | Experimental | Procedure: Tip bendable suction ureteral access sheathPatients will use S-UAS during flexible ureteroscopy. |
| Traditional ureteral access sheath group | No intervention | –Patients will use traditional UAS during flexible ureteroscopy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adults aged ≥ 18 years;
- American Society of Anesthesiology score 1-3;
- Upper urinary stone (kidney stone or upper ureteral stone) diameter of ≤ 3 cm confirmed by CT;
- Capable of giving written informed consent, which includes adherence with the requirements of the trial.
Key exclusion criteria (4 listed)
- Patients with abnormal urinary tract anatomy (such as horseshoe kidney or ileal conduit);
- Patients with uncontrolled UTI;
- Patients with health or other factors that are absolute contraindications to RIRS;
- Patients unable to understand or complete trial documentation.
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 |
|---|---|---|
| Tip bendable suction ureteral access sheathPatient use tip bendable suction ureteral access sheath during flexible ureteroscopy to see if flexible ureteroscopy with S-UAS offers the better treatment outcomes in terms of clinical effectiveness and post-operative complications. | Procedure or surgery | Tip bendable suction ureteral access sheath (S-UAS) group |
Primary outcome
Immediate stone-free rate
Time frame: Postoperative day 1
No residual stone, or no stone fragments larger than 2 mm on KUB and ultrasound at postoperative day 1 are defined as stone free.
6 secondary outcomes
Stone-free rate at 3 months
Time frame: Postoperative 3 month
Duration of hospital stay
Time frame: From date of operation until the date of discharge, assessed up to 2 weeks.
Further interventions received up to 3 months post randomization
Time frame: Postoperative 3 month
Complications up to 3 months post randomization
Time frame: Postoperative 3 month
Change of Quality of life Score (prior to surgery and at month 3 after randomization)
Time frame: Postoperative 3 month
Operative time
Time frame: From start of operation until the end of operation, assessed up to 2 weeks.
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 25 Jun 2024.
- Derived from this study: PubMed 39070176Zhu W, Liu S, Cao J, Wang H, Liang H, Jiang K, Cui Y, Chai CA, Sahinler EB, Aquino A, Mazzon G, Zhong W, Zhao Z, Zhang L, Ding J, Wang Q, Wang Y, Chen KW, Liu Y, Choong S, Sarica K, Zeng G. Tip bendable suction ureteral access sheath versus traditional sheath in retrograde intrarenal stone surgery: an international multicentre, randomized, parallel group, superiority study. EClinicalMedicine. 2024 Jul 5;74:102724. doi: 10.1016/j.eclinm.2024.102724. eCollection 2024 Aug.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tip bendable suction ureteral access sheath in people with Kidney Stone, run by The First Affiliated Hospital of Guangzhou Medical University 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 4 inclusion and 4 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 25 Jun 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?
Immediate stone-free rate (time frame: Postoperative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05952635, which also lists 1 linked publication.
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 25 Jun 2024.