Ureteric StoneNCT03404986
Ultrasound Guided Ureteroscopy and Ureteric Stones
A study testing ureteroscopy and Ultrasonography in people with Ureteric Stone, run by Assiut University at 1 site in Egypt.
Trial summary
The prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11 people in the United States. The prevalence of calculi in Afro-Asian region including Arab Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for definitive management of ureteric stones. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Ureteric Stone
- What is being tested?
- ureteroscopy and Ultrasonography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2018to 1 Apr 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
- Age group 18 years old or above.
- Stone size 15 mm or less.
Who cannot join
- Patients with bilateral ureteric stones
- Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
- Previously failed ureteroscopy or previous ureteroneocystostomy.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided Ureteroscopy for the Treatment of Lower Third Ureteric Stones in Adults
The prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11 people in the United States. The prevalence of calculi in Afro-Asian region including Arab Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for definitive management of ureteric stones. Conventional ureteroscopy relies on intraoperative fluoroscopy for visualization and guidance, exposing the patient, surgeon and operating room staff to ionizing radiation. To minimize the hazards of ionizing radiation there has been a trend toward radiation free alternative imaging modalities . Ultrasound provides an excellent alternative for upper urinary tract imaging because it is radiation free, rapid, portable and allows excellent visualization of the renal pelvis and calyces. There is increasing awareness and concern about the clinical use of ionizing radiation and the need to decrease exposure of patients and medical professionals. Ultrasound guided ureteroscopy in pregnant females and children- in whom fluoroscopy is to be minimized or avoided when possible - has been reported.
- Conditions
- Ureteric Stone
- Being tested
- ureteroscopy, Ultrasonography
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ureteroscopyProcedure or surgery
The patients will be subjected to rigid ureteroscopy
UltrasonographyRadiation
The patients will be subjected to Ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Standardized ureteroscopy group | Other | Not described Receives: Procedure: ureteroscopy |
| Ultrasonography ureteroscopy group | Other | Not described Receives: Procedure: ureteroscopy; Radiation: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients treated effectively by the two methods
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2018
- Study start1 Apr 2018
- Primary completion1 Apr 2020
- Study completion1 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ureteric StoneStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Loay, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03404986
- Sponsor's protocol ID
- USUUS
- Status last verified
- Dec 2022
- First submitted
- 14 Jan 2018
- Last updated
- 5 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Ureteroscopy for the Treatment of Lower Third Ureteric Stones in Adults
- ClinicalTrials.gov ID
- NCT03404986
- Acronym / sponsor ID
- USUUS
- Conditions
- Ureteric Stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 1 Apr 2020 (actual)
- Study completion
- 1 Apr 2020 (actual)
- First posted
- 19 Jan 2018 (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 prevalence of urolithiasis is steadily increasing with an estimation of 1 out of 11 people in the United States. The prevalence of calculi in Afro-Asian region including Arab Republic of Egypt ranges from 4% to 20%. Ureteroscopy is one of the first line treatments for definitive management of ureteric stones. Conventional ureteroscopy relies on intraoperative fluoroscopy for visualization and guidance, exposing the patient, surgeon and operating room staff to ionizing radiation. To minimize the hazards of ionizing radiation there has been a trend toward radiation free alternative imaging modalities . Ultrasound provides an excellent alternative for upper urinary tract imaging because it is radiation free, rapid, portable and allows excellent visualization of the renal pelvis and calyces. There is increasing awareness and concern about the clinical use of ionizing radiation and the need to decrease exposure of patients and medical professionals. Ultrasound guided ureteroscopy in pregnant females and children- in whom fluoroscopy is to be minimized or avoided when possible - has been reported.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standardized ureteroscopy group | Other | Procedure: ureteroscopy |
| Ultrasonography ureteroscopy group | Other | Procedure: ureteroscopy, Radiation: Ultrasonography |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients with single symptomatic lower third ureteric radio-opaque stones indicated for endoscopic treatment.
- Age group 18 years old or above.
- Stone size 15 mm or less.
Key exclusion criteria (3 listed)
- Patients with bilateral ureteric stones
- Ureteric congenital anomalies e.g. double ureter and ectopic ureter.
- Previously failed ureteroscopy or previous ureteroneocystostomy.
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 |
|---|---|---|
| ureteroscopyThe patients will be subjected to rigid ureteroscopy | Procedure or surgery | Standardized ureteroscopy group, Ultrasonography ureteroscopy group |
| UltrasonographyThe patients will be subjected to Ultrasonography | Radiation | Ultrasonography ureteroscopy group |
Primary outcome
Number of patients treated effectively by the two methods
Time frame: 1 hour
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 5 Dec 2022.
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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 ureteroscopy and Ultrasonography in people with Ureteric Stone, run by Assiut University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 5 Dec 2022. 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 Egypt. 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?
Number of patients treated effectively by the two methods (time frame: 1 hour). 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 5 Dec 2022.