Ureter StoneNCT05416502
Prospective Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Distal Lumen
An observational study of Ureter Stone, run by Hiram's Healthcare and Education Company at 1 site in Turkey (Türkiye).
Trial summary
Patients (female, male, or queer) with ureteral stones (smaller than 1 cm at the widest diameter of the stone) without pyonephrosis, urinary sepsis, or untraceable pain will be enrolled into the study. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Ureter Stone
- What is being tested?
- Ultrasound
- Type of treatment
- Surgery or procedure
- How many people
- 1,000 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2021to 1 Jan 2023
- How long will I take part?
- 3 Months
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with ureter stones
Who may be able to join
- Ureteral Stone smaller than 1 cm Volunteer to be enrolled
Who cannot join
- Pyonephrosis Urinary Sepsis Untraceable Pain
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Ataturk University
Erzurum
Fatih Ozkaya, MD, +90 505 943 6892, fatih.ozkaya@atauni.edu.tr
About this study
Official title: Prospective Observational Evaluation of the Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Diameter of the Most Narrow Part of the Distal Ureter
Patients (female, male, or queer) with ureteral stones (smaller than 1 cm at the widest diameter of the stone) without pyonephrosis, urinary sepsis, or untraceable pain will be enrolled into the study. Ureteral width at the smallest area of the ureter (in most cases UV junction) will be noted during regular ultrasound scans. The ratio of ureteral width to the stone diameter will be correlated with the spontaneous stone passage.
- Conditions
- Ureter Stone
- Being tested
- Ultrasound
- Medical subject headings
- Ureterolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Enrolled patients underwent ultrasound scan of kidneys, ureters, and the bladder.
| Study group | Role | What they receive |
|---|---|---|
| Passage Observed | Enrolled patients whose stone and ureter diameters are obtained and their stone passage was successful during the follow-up. Receives: Procedure: Ultrasound | |
| Passage Not Observed | Enrolled patients whose stone and ureter diameters are obtained and their stone passage was not successful during the follow-up. Receives: Procedure: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Passage
The number of recruited individuals whose ureteral stones are found to be passed by their report and it is confirmed by ultrasound
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2022
- Study start1 Jan 2021
- Primary completion1 Jan 2023 (estimated)
- Study completion1 Jan 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Hiram's Healthcare and Education Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Ataturk University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05416502
- Sponsor's protocol ID
- B.30.2.ATA.0.01.00
- Status last verified
- Jun 2022
- First submitted
- 16 Nov 2021
- Last updated
- 13 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be shared among the following criteria: * As allowed to the degree which is allowed by the enrolled patients. * As required by the researchers
Study at a glance
From the registry record, last updated by the sponsor on 13 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Evaluation of the Relationship Between the Rates of Spontaneous Passage of Distal Ureteral Stones and the Diameter of the Most Narrow Part of the Distal Ureter
- ClinicalTrials.gov ID
- NCT05416502
- Acronym / sponsor ID
- B.30.2.ATA.0.01.00
- Conditions
- Ureter Stone
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Hiram's Healthcare and Education CompanyIndustry (pharma, biotech, devices)
- Collaborators
- Ataturk University
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jan 2023 (estimated)
- Study completion
- 1 Jan 2023 (estimated)
- First posted
- 13 Jun 2022 (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 (female, male, or queer) with ureteral stones (smaller than 1 cm at the widest diameter of the stone) without pyonephrosis, urinary sepsis, or untraceable pain will be enrolled into the study. Ureteral width at the smallest area of the ureter (in most cases UV junction) will be noted during regular ultrasound scans. The ratio of ureteral width to the stone diameter will be correlated with the spontaneous stone passage.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Passage Observed | – | Procedure: UltrasoundEnrolled patients whose stone and ureter diameters are obtained and their stone passage was successful during the follow-up. |
| Passage Not Observed | – | Procedure: UltrasoundEnrolled patients whose stone and ureter diameters are obtained and their stone passage was not successful during the follow-up. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with ureter stones
Key inclusion criteria (1 listed)
- Ureteral Stone smaller than 1 cm Volunteer to be enrolled
Key exclusion criteria (1 listed)
- Pyonephrosis Urinary Sepsis Untraceable Pain
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 |
|---|---|---|
| UltrasoundEnrolled patients underwent ultrasound scan of kidneys, ureters, and the bladder. | Procedure or surgery | Passage Not Observed, Passage Observed |
Primary outcome
Passage
Time frame: 3 months
The number of recruited individuals whose ureteral stones are found to be passed by their report and it is confirmed by ultrasound
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jun 2022.
- Individual participant dataSharing planned: Yes. IPD will be shared among the following criteria: * As allowed to the degree which is allowed by the enrolled patients. * As required by the researchers
Related trials for Ureter Stone
Recruiting
The Effect of Acupuncture on Passing Ureteral Stones
Ureter Calculi
Not yet recruiting
DISS vs FANS in Suction-Assisted RIRS for Medium-Sized Renal Stones
Kidney Stones, Nephrolithiasis
Active, not recruiting
Methocarbamol vs Oxybutynin for Management of Pain and Discomfort S/P Ureteroscopy Procedure
Kidney Calculi, Kidney Diseases
Recruiting
Human Voice vs AI-Cloned Voice Audio Added to Written Consent Before Ureteroscopy or Retrograde Intrarenal Surgery (AUDIO-CONSENT)
Urolithiasis, Kidney Calculi
RecruitingPhase 4
Comparison of Mirabegron and Tamsulosin for Ureteral Stone Expulsion
Ureteral Calculi
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.
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 Ureter Stone, run by Hiram's Healthcare and Education Company at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 13 Jun 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 Turkey (Türkiye). 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 Ozer U Cakici, MD, FEBU (+90 541 461 20 51, ozerural@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Passage (time frame: 3 months). 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 13 Jun 2022.