Ureter StoneNCT03980444
Effectiveness Basket Wires for the Maintenance of Stone and Pneumatic Probe in the Treatment of Ureteral Stones
A study testing Basket of wire in people with Ureter Stone, run by Mohammad Sadegh Bagheri Baghdasht at 2 sites in Iran.
Trial summary
Patients included in the study included the necessary tests U / A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. Patients were prepared for action. The demographic and clinical data of the patients, including age, sex, size, and location of the stones were recorded. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Ureter Stone
- What is being tested?
- Basket of wire
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 124 participants
- Where
- 2 sitesIran
- Study dates
- 29 Apr 2015to 20 Apr 2018
- 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 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Individual interest in engaging in research
- Patients with ureter stones
- Symptoms of severe and resistant to supportive and therapeutic treatment
- Ureteral stones cause ureteral obstruction
- Ureteral stones, which is not likely to be disposed of by duration and size, have been selected for ureteroscopic lithotripsy.
Who cannot join
- Patients with urinary tract infection
- Not having a proper cardiovascular condition and not approved by a cardiologist or anesthetist
- Patients who are dissatisfied with ureteroscopic crushing and patients who do not have access to rocks during ureteroscopic surgery
- Individual interest in leaving the study
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Determine the Effectiveness of Convective Uses of Basket Wires for the Maintenance of Stone and Pneumatic Probe in the Treatment of Ureteral Stones
Patients included in the study included the necessary tests U / A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. Patients were prepared for action. The demographic and clinical data of the patients, including age, sex, size, and location of the stones were recorded.
Then patients as random allocation were divided into two groups: A (control group, no basket of bases and group B (use of pneumatic synchronous buccal waist). The dividing person and the patients themselves were not aware of which group they were in. They were double-blind was.
Read more
In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.
During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion.
In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the ureteroscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as the control group. Ureteroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered.
- Conditions
- Ureter Stone
- Being tested
- Basket of wire, control group, no basket
- Keywords
- Ureterolithiasis, Manganese Poisoning, Lithotripsy, Ureteroscopy, stone baske
- Medical subject headings
- Ureterolithiasis, Manganese Poisoning
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Basket of wireDevice
(using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as control group. Urethroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered
control group, no basketProcedure or surgery
In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.
During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion.
| Study group | Role | What they receive |
|---|---|---|
| control group, no basket of wire | Experimental | The dividing person and the patients themselves were not aware of which group they were in. They were double-blind Was.
In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.
During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion. Receives: Procedure: control group, no basket |
| using a basket of wires | Sham comparator | In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as control group. Urethroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered Receives: Device: Basket of wire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Stone size
The largest diameter of the stone in the imaging of millimeters
Measured: 24 hours
Crushing time
Duration needed to break the stone to the minute
Measured: up to 23minute
Demographic questionnaire
The demographic questionnaire was used to collect information
Measured: 24 hours
Troma in the ureter area
Follow up of patients for perforation, missing stone, and ureter ligation according to observations during and after surgery
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2019
- Study start29 Apr 2015
- Primary completion18 Jan 2017
- Study completion20 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Ureter StoneStudies 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
- Model description
- Patients included in the study included the necessary tests U/A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. The demographic and clinical data of the patients were recorded. Then patients as random allocation were divided into two groups: A (control group) and group B (use of a pneumatic basket of wire). The dividing person and the patients themselves were not aware of which group they were in. In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A, the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock. In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the same as A group.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 124 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mohammad Sadegh Bagheri Baghdasht
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mohammad Sadegh Bagheri Baghdasht, Baqiyatallah Medical Sciences University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03980444
- Sponsor's protocol ID
- IR.BMSU.REC.1393.4
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2019
- Last updated
- 10 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Elashry OM, Tawfik AM. Preventing stone retropulsion during intracorporeal lithotripsy. Nat Rev Urol. 2012 Dec;9(12):691-8. doi: 10.1038/nrurol.2012.204. Epub 2012 Nov 20.
PubMed 23165399Rane A, Bradoo A, Rao P, Shivde S, Elhilali M, Anidjar M, Pace K, D'A Honey JR. The use of a novel reverse thermosensitive polymer to prevent ureteral stone retropulsion during intracorporeal lithotripsy: a randomized, controlled trial. J Urol. 2010 Apr;183(4):1417-21. doi: 10.1016/j.juro.2009.12.023. Epub 2010 Feb 20.
PubMed 20171695Vejdani K, Eisner BH, Pengune W, Stoller ML. Effect of laser insult on devices used to prevent stone retropulsion during ureteroscopic lithotripsy. J Endourol. 2009 Feb;23(2):249-51. doi: 10.1089/end.2008.0352.
PubMed 19220084Ursiny M, Eisner BH. Cost-effectiveness of anti-retropulsion devices for ureteroscopic lithotripsy. J Urol. 2013 May;189(5):1762-6. doi: 10.1016/j.juro.2012.11.085. Epub 2012 Nov 15.
PubMed 23159589Wu JA, Ngo TC, Hagedorn JC, Macleod LC, Chung BI, Shinghal R. The accordion antiretropulsive device improves stone-free rates during ureteroscopic laser lithotripsy. J Endourol. 2013 Apr;27(4):438-41. doi: 10.1089/end.2012.0332. Epub 2013 Feb 6.
PubMed 23387558Pagnani CJ, El Akkad M, Bagley DH. Prevention of stone migration with the Accordion during endoscopic ureteral lithotripsy. J Endourol. 2012 May;26(5):484-8. doi: 10.1089/end.2011.0386. Epub 2012 Jan 4.
PubMed 22192096Farahat YA, Elbahnasy AE, Elashry OM. A randomized prospective controlled study for assessment of different ureteral occlusion devices in prevention of stone migration during pneumatic lithotripsy. Urology. 2011 Jan;77(1):30-5. doi: 10.1016/j.urology.2010.05.063. Epub 2010 Oct 20.
PubMed 20970173
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determine the Effectiveness of Convective Uses of Basket Wires for the Maintenance of Stone and Pneumatic Probe in the Treatment of Ureteral Stones
- ClinicalTrials.gov ID
- NCT03980444
- Acronym / sponsor ID
- IR.BMSU.REC.1393.4
- Conditions
- Ureter Stone
- Keywords
- Ureterolithiasis, Manganese Poisoning, Lithotripsy, Ureteroscopy, stone baske
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 124 participants (actual)
- Lead sponsor
- Mohammad Sadegh Bagheri BaghdashtUniversity, hospital or other
- Study start
- 29 Apr 2015 (actual)
- Primary completion
- 18 Jan 2017 (actual)
- Study completion
- 20 Apr 2018 (actual)
- First posted
- 10 Jun 2019 (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.
Patients included in the study included the necessary tests U / A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. Patients were prepared for action. The demographic and clinical data of the patients, including age, sex, size, and location of the stones were recorded.
Then patients as random allocation were divided into two groups: A (control group, no basket of bases and group B (use of pneumatic synchronous buccal waist). The dividing person and the patients themselves were not aware of which group they were in. They were double-blind was.
In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock.
During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion.
In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the ureteroscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as the control group. Ureteroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Patients included in the study included the necessary tests U/A, K, Na, Cr, BUN, CBC, And U / C was checked and anesthesia counseling was done. The demographic and clinical data of the patients were recorded. Then patients as random allocation were divided into two groups: A (control group) and group B (use of a pneumatic basket of wire). The dividing person and the patients themselves were not aware of which group they were in. In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A, the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock. In group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the same as A group.
| Arm | Type | Receives |
|---|---|---|
| control group, no basket of wire | Experimental | Procedure: control group, no basketThe dividing person and the patients themselves were not aware of which group they were in. They were double-blind Was. In each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock. During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion. |
| using a basket of wires | Sham comparator | Device: Basket of wireIn group B (using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as control group. Urethroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Individual interest in engaging in research
- Patients with ureter stones
- Symptoms of severe and resistant to supportive and therapeutic treatment
- Ureteral stones cause ureteral obstruction
- Ureteral stones, which is not likely to be disposed of by duration and size, have been selected for ureteroscopic lithotripsy.
Key exclusion criteria (4 listed)
- Patients with urinary tract infection
- Not having a proper cardiovascular condition and not approved by a cardiologist or anesthetist
- Patients who are dissatisfied with ureteroscopic crushing and patients who do not have access to rocks during ureteroscopic surgery
- Individual interest in leaving the study
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 |
|---|---|---|
| Basket of wire(using a basket of wires3F) the helical type was passed through the four wires of the working channel of the orthoscope and routed to the proximal part of the rock, and the stone was routed to the bowl, then the stone was ducted The gasket was kept, and the probe of the pneumatic crusher also passed through the working channel and proceeded to break it down. Conditions were observed during the stomach as control group. Urethroscopic crushing was performed by a urologist in both groups under similar technical conditions. Findings during and after the completion of crushing include the success, stone retropulsion or parts larger than 3 mm, which requires secondary measures (SWL - ureter stenting, resection ureteroscopy), the duration of stone breakdown and traumatic ureteric complications in both groups it is registered | Device | using a basket of wires |
| control group, no basketIn each group, ureteroscopy was performed using a standard F9.5 ureteroscope. After reaching the rock in group A (control), the probe of the pneumatic crusher was passed through the working channel of the ureteroscope and began crushing the rock. During the crushing process, the minimum flow of water, flattening and the single-shot impact was used to minimize the stone's retropulsion. | Procedure or surgery | control group, no basket of wire |
Primary outcome
Stone size
Time frame: 24 hours
The largest diameter of the stone in the imaging of millimeters
Crushing time
Time frame: up to 23minute
Duration needed to break the stone to the minute
Demographic questionnaire
Time frame: 24 hours
The demographic questionnaire was used to collect information
Troma in the ureter area
Time frame: up to 24 hours
Follow up of patients for perforation, missing stone, and ureter ligation according to observations during and after surgery
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 10 Jun 2019.
- Results publication: PubMed 23165399Elashry OM, Tawfik AM. Preventing stone retropulsion during intracorporeal lithotripsy. Nat Rev Urol. 2012 Dec;9(12):691-8. doi: 10.1038/nrurol.2012.204. Epub 2012 Nov 20.
- Results publication: PubMed 20171695Rane A, Bradoo A, Rao P, Shivde S, Elhilali M, Anidjar M, Pace K, D'A Honey JR. The use of a novel reverse thermosensitive polymer to prevent ureteral stone retropulsion during intracorporeal lithotripsy: a randomized, controlled trial. J Urol. 2010 Apr;183(4):1417-21. doi: 10.1016/j.juro.2009.12.023. Epub 2010 Feb 20.
- Results publication: PubMed 19220084Vejdani K, Eisner BH, Pengune W, Stoller ML. Effect of laser insult on devices used to prevent stone retropulsion during ureteroscopic lithotripsy. J Endourol. 2009 Feb;23(2):249-51. doi: 10.1089/end.2008.0352.
- Results publication: PubMed 23159589Ursiny M, Eisner BH. Cost-effectiveness of anti-retropulsion devices for ureteroscopic lithotripsy. J Urol. 2013 May;189(5):1762-6. doi: 10.1016/j.juro.2012.11.085. Epub 2012 Nov 15.
- Results publication: PubMed 23387558Wu JA, Ngo TC, Hagedorn JC, Macleod LC, Chung BI, Shinghal R. The accordion antiretropulsive device improves stone-free rates during ureteroscopic laser lithotripsy. J Endourol. 2013 Apr;27(4):438-41. doi: 10.1089/end.2012.0332. Epub 2013 Feb 6.
- Results publication: PubMed 22192096Pagnani CJ, El Akkad M, Bagley DH. Prevention of stone migration with the Accordion during endoscopic ureteral lithotripsy. J Endourol. 2012 May;26(5):484-8. doi: 10.1089/end.2011.0386. Epub 2012 Jan 4.
- Results publication: PubMed 20970173Farahat YA, Elbahnasy AE, Elashry OM. A randomized prospective controlled study for assessment of different ureteral occlusion devices in prevention of stone migration during pneumatic lithotripsy. Urology. 2011 Jan;77(1):30-5. doi: 10.1016/j.urology.2010.05.063. Epub 2010 Oct 20.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Basket of wire in people with Ureter Stone, run by Mohammad Sadegh Bagheri Baghdasht at 2 sites in Iran.
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 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 10 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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. Some participants in this study may receive a placebo. 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?
Stone size (time frame: 24 hours). The study lists 4 primary outcomes in all. 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 NCT03980444, which also lists 7 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 10 Jun 2019.