Renal CalculusNCT03105206
A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
An observational study of Renal Calculus, run by Changhai Hospital at 1 site in China.
Trial summary
This study centers on the treatment of low pole renal stones by flexible ureteroscope and intends to find the key anatomical parameters using a prospective, randomized multi-center trial design and to make a more appropriate standard for flexible ureteroscopy of low pole renal stones. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Renal Calculus
- What is being tested?
- Flexible Ureteroscopy
- Type of treatment
- Surgery or procedure
- How many people
- 1,100 participants
- Where
- 1 siteChina
- Study dates
- 1 May 2017to Dec 2019
- Phase
- Observational
- 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
Study population: low pole renal calculus patients
Who may be able to join
- • Subject has provided informed consent and indicated a willingness to comply with study treatments
- Subject is 18-70 yrs of age
- Subject can be either male or female
- Subject has a diagnosis of low pole renal stones according to CT urography(CTU) or intravenous pyelogram (IVP) results
- Subject has a single stone 1~2cm in size (KUB), or multiple stones 1~2cm in cumulative size (KUB), and is a surgical candidate for the ureteroscopic approach
Who cannot join
- • Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
- Subject has been diagnosed with a urethral stricture or bladder neck contracture
- Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
- Subject has severe hematuria that might blur the vision of the endoscopy
- Subject is pregnant or in monthly period
- Subject has coexistent disease like systemic disease, heart disease, lung disfunction or other diseases that could not tolerate the endoscopic surgery or anesthesia.
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- Subject has unadjusted diabetes or high blood pressure
- Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
- Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (2 weeks)
- Subject has been diagnosed with hydronephrosis larger than 3cm according to the B-scan ultrasonography examination
- Subject has any kind of anatomic abnormality of the urinary system that might have an influence on the surgery
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Changhai Hospital
Shanghai, Shanghai Municipality, 200433
Gao Xiaofeng, MD, 0086-13601600968, gxfdoc@hotmail.com
Peng Yonghan, MD, 0086-13917386896, yonghanyhtl@163.com
About this study
This study centers on the treatment of low pole renal stones by flexible ureteroscope and intends to find the key anatomical parameters using a prospective, randomized multi-center trial design and to make a more appropriate standard for flexible ureteroscopy of low pole renal stones.
Read the detailed description
With the development of manufacturing technique, new generation of flexible ureteroscopes have great initiative and passive bending capacity and have greatly expanded its application. In our clinical practice, we have found that IPA (Infundibulopelvic angle) is no longer a decisive factor for the success of f-URS（flexible ureteroscope） surgeries. Thus, we think it is necessary to have further study on the effect of anatomy of renal collecting system for f-URS surgeries.
- Conditions
- Renal Calculus
- Being tested
- Flexible Ureteroscopy
- Keywords
- lowl pole renal calculus, anatomical parameters, flexible ureteroscopy
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Flexible UreteroscopyProcedure or surgery
the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
| Study group | Role | What they receive |
|---|---|---|
| Low Pole Renal Calculus | patients with low pole renal calculus who are suitable to treat by flexible ureteroscopy Receives: Procedure: Flexible Ureteroscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
whether the f-URS could enter the low kidney calyx or not
Following conditions are regarded as failures: 1. the f-URS couldn't enter the low kidney calyx 2. Though the f-URS has entered the low kidney calyx, it cannot crush the stone.
Measured: during the operation
Secondary outcomes (1)
stone clearance
Check NECT（nonenhanced CT）, no residual or residual stones are smaller than 2mm in total refers to clear success.Number of participants undergo f-URS surgeries without residual calculus/Total number of participants in each group *100%=stone clearance
Measured: 4 weeks post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 May 2017
- Primary completionNov 2019 (estimated)
- Study completionDec 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Renal CalculusStudies of the same condition, open and under way.
- More trials run by Changhai HospitalThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changhai Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, The First Affiliated Hospital of Anhui Medical University, Tongji Hospital, Renmin Hospital of Wuhan University, The Second People's Hospital of GuangDong Province, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Nanchang University, West China Hospital, The First Affiliated Hospital of Xiamen University, Zhejiang Provincial People's Hospital
- Responsible party
- Principal investigator, Xiaofeng Gao, Changhai Hospital
- Investigators
- Gao Xiaofeng, MD, Principal investigator, Changhai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105206
- Sponsor's protocol ID
- SHOT-20161208
- Status last verified
- Feb 2019
- First submitted
- 2 Apr 2017
- Last updated
- 12 Feb 2019
- Results posted
- No
Publications
Jessen JP, Honeck P, Knoll T, Wendt-Nordahl G. Flexible ureterorenoscopy for lower pole stones: influence of the collecting system's anatomy. J Endourol. 2014 Feb;28(2):146-51. doi: 10.1089/end.2013.0401. Epub 2013 Nov 19.
PubMed 24083332Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.
PubMed 21855968Geavlete P, Jecu M, Geavlete B, Multescu R, Nita G, Georgescu D. Ureteroscopy--an essential modern approach in upper urinary tract diagnosis and treatment. J Med Life. 2010 Apr-Jun;3(2):193-9.
PubMed 20968209Madbouly K, Sheir KZ, Elsobky E. Impact of lower pole renal anatomy on stone clearance after shock wave lithotripsy: fact or fiction? J Urol. 2001 May;165(5):1415-8.
PubMed 11342888Lin CC, Hsu YS, Chen KK. Predictive factors of lower calyceal stone clearance after extracorporeal shockwave lithotripsy (ESWL): the impact of radiological anatomy. J Chin Med Assoc. 2008 Oct;71(10):496-501. doi: 10.1016/S1726-4901(08)70157-6.
PubMed 18955183Knoll T, Musial A, Trojan L, Ptashnyk T, Michel MS, Alken P, Kohrmann KU. Measurement of renal anatomy for prediction of lower-pole caliceal stone clearance: reproducibility of different parameters. J Endourol. 2003 Sep;17(7):447-51. doi: 10.1089/089277903769013577.
PubMed 14565873Wendt-Nordahl G, Mut T, Krombach P, Michel MS, Knoll T. Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors? Urol Res. 2011 Jun;39(3):185-8. doi: 10.1007/s00240-010-0331-0. Epub 2010 Nov 5.
PubMed 21052986Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3.
PubMed 24890883
Study at a glance
From the registry record, last updated by the sponsor on 12 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter Prospective Research on the Treatment of Low Pole Renal Calculus by Flexible Ureteroscope
- ClinicalTrials.gov ID
- NCT03105206
- Acronym / sponsor ID
- SHOT-20161208
- Conditions
- Renal Calculus
- Keywords
- lowl pole renal calculus, anatomical parameters, flexible ureteroscopy
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Changhai HospitalUniversity, hospital or other
- Collaborators
- Shanghai Changzheng Hospital, The First Affiliated Hospital of Anhui Medical University, Tongji Hospital, Renmin Hospital of Wuhan University, The Second People's Hospital of GuangDong Province, Jiangsu Provincial People's Hospital, The First Affiliated Hospital of Nanchang University, West China Hospital, The First Affiliated Hospital of Xiamen University, Zhejiang Provincial People's Hospital
- Study start
- 1 May 2017 (actual)
- Primary completion
- Nov 2019 (estimated)
- Study completion
- Dec 2019 (estimated)
- First posted
- 7 Apr 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.
This study centers on the treatment of low pole renal stones by flexible ureteroscope and intends to find the key anatomical parameters using a prospective, randomized multi-center trial design and to make a more appropriate standard for flexible ureteroscopy of low pole renal stones.
Detailed description
With the development of manufacturing technique, new generation of flexible ureteroscopes have great initiative and passive bending capacity and have greatly expanded its application. In our clinical practice, we have found that IPA (Infundibulopelvic angle) is no longer a decisive factor for the success of f-URS（flexible ureteroscope） surgeries. Thus, we think it is necessary to have further study on the effect of anatomy of renal collecting system for f-URS surgeries.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low Pole Renal Calculus | – | Procedure: Flexible Ureteroscopypatients with low pole renal calculus who are suitable to treat by flexible ureteroscopy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- low pole renal calculus patients
Key inclusion criteria (5 listed)
- • Subject has provided informed consent and indicated a willingness to comply with study treatments
Key exclusion criteria (11 listed)
- • Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
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 |
|---|---|---|
| Flexible Ureteroscopythe Treatment of Low Pole Renal Calculus by Flexible Ureteroscope | Procedure or surgery | Low Pole Renal Calculus |
Primary outcome
whether the f-URS could enter the low kidney calyx or not
Time frame: during the operation
Following conditions are regarded as failures: 1. the f-URS couldn't enter the low kidney calyx 2. Though the f-URS has entered the low kidney calyx, it cannot crush the stone.
1 secondary outcome
stone clearance
Time frame: 4 weeks post-operatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Feb 2019.
- Results publication: PubMed 24083332Jessen JP, Honeck P, Knoll T, Wendt-Nordahl G. Flexible ureterorenoscopy for lower pole stones: influence of the collecting system's anatomy. J Endourol. 2014 Feb;28(2):146-51. doi: 10.1089/end.2013.0401. Epub 2013 Nov 19.
- Results publication: PubMed 21855968Resorlu B, Oguz U, Resorlu EB, Oztuna D, Unsal A. The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stones. Urology. 2012 Jan;79(1):61-6. doi: 10.1016/j.urology.2011.06.031.
- Results publication: PubMed 20968209Geavlete P, Jecu M, Geavlete B, Multescu R, Nita G, Georgescu D. Ureteroscopy--an essential modern approach in upper urinary tract diagnosis and treatment. J Med Life. 2010 Apr-Jun;3(2):193-9.
- Results publication: PubMed 11342888Madbouly K, Sheir KZ, Elsobky E. Impact of lower pole renal anatomy on stone clearance after shock wave lithotripsy: fact or fiction? J Urol. 2001 May;165(5):1415-8.
- Results publication: PubMed 18955183Lin CC, Hsu YS, Chen KK. Predictive factors of lower calyceal stone clearance after extracorporeal shockwave lithotripsy (ESWL): the impact of radiological anatomy. J Chin Med Assoc. 2008 Oct;71(10):496-501. doi: 10.1016/S1726-4901(08)70157-6.
- Results publication: PubMed 14565873Knoll T, Musial A, Trojan L, Ptashnyk T, Michel MS, Alken P, Kohrmann KU. Measurement of renal anatomy for prediction of lower-pole caliceal stone clearance: reproducibility of different parameters. J Endourol. 2003 Sep;17(7):447-51. doi: 10.1089/089277903769013577.
- Results publication: PubMed 21052986Wendt-Nordahl G, Mut T, Krombach P, Michel MS, Knoll T. Do new generation flexible ureterorenoscopes offer a higher treatment success than their predecessors? Urol Res. 2011 Jun;39(3):185-8. doi: 10.1007/s00240-010-0331-0. Epub 2010 Nov 5.
- Results publication: PubMed 24890883Geavlete P, Multescu R, Geavlete B. Pushing the boundaries of ureteroscopy: current status and future perspectives. Nat Rev Urol. 2014 Jul;11(7):373-82. doi: 10.1038/nrurol.2014.118. Epub 2014 Jun 3.
- Flexible ureterorenoscopy for lower pole stones: influence of the collecting system's anatomyLink provided by the sponsor.
- The impact of pelvicaliceal anatomy on the success of retrograde intrarenal surgery in patients with lower pole renal stonesLink provided by the sponsor.
- Ureteroscopy--an essential modern approach in upper urinary tract diagnosis and treatmentLink provided by the sponsor.
- Impact of lower pole renal anatomy on stone clearance after shock wave lithotripsy: fact or fictionLink provided by the sponsor.
- Predictive factors of lower calyceal stone clearance after extracorporeal shockwave lithotripsy (ESWL): the impact of radiological anatomyLink provided by the sponsor.
- Measurement of renal anatomy for prediction of lower-pole caliceal stone clearance: reproducibility of different parametersLink provided by the sponsor.
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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.
Gao Xiaofeng, MD principal investigator
Changhai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renal Calculus, run by Changhai 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 5 inclusion and 11 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 12 Feb 2019. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Gao Xiaofeng, MD (086-13601600968, gxfdoc@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
whether the f-URS could enter the low kidney calyx or not (time frame: during the operation). 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 NCT03105206, which also lists 8 linked publications.
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 12 Feb 2019.