Renal ColicPOCUSNCT07126847
Use of POCUS and STONE Criteria Together in the Diagnosis of Nephrolithiasis
An observational study of Renal Colic and Stone, Kidney, run by Kocaeli City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Patients presenting to the emergency department with symptoms suggestive of renal colic will be included in the study at Kocaeli City Hospital's emergency department. Patients with nephrolithiasis considered among the preliminary diagnoses will be enrolled in the study; demographic data, vital signs, and physical… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Renal Colic, Stone, Kidney, Hydronephrosis
- What is being tested?
- Renal Ultrasonography
- How many people
- 490 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Feb 2024to 31 Dec 2025
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Volunteer patients over the age of 18 who applied to the emergency department of Kocaeli City Hospital with renal colic will be included in the study.
Who may be able to join
- All volunteer patients
Who cannot join
- Pregnant patients,
- Patients for whom the clinician does not give an indication for computed tomography,
- Patients with a previous history of nephrectomy and kidney transplantation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Success of POCUS Usage in Addition to STONE Criteria in Diagnosing Nephrolithiasis and Predicting Readmission Within One Month in Patients Presenting to the Emergency Department With Suspected Nephrolithiasis
Patients presenting to the emergency department with symptoms suggestive of renal colic will be included in the study at Kocaeli City Hospital's emergency department. Patients with nephrolithiasis considered among the preliminary diagnoses will be enrolled in the study; demographic data, vital signs, and physical examination findings will be recorded on pre-prepared standard data forms.
STONE criteria scores will be calculated by emergency assistants, and bedside ultrasound will be performed for patients. Ultrasonographic findings suggestive of renal colic, such as hydronephrosis, the presence of primary stones, acoustic shadowing of the stone, the presence of twinkle artifact, presence of jet flow, and presence of bladder debris, will be evaluated, and the obtained data will be recorded on the standard data form by the performing assistant physician. In patients where computed tomography, which is the gold standard for detecting stone presence without intervention, is deemed appropriate without any intervention to the primary examining physician, the computed tomography results and ultrasound findings will be compared.
The study aims to evaluate the effectiveness of bedside ultrasound application in diagnosing stone presence in patients, its success in predicting re-admission to the hospital within 1 month, its success in predicting possible alternative diagnoses and complications, in addition to the stone criteria applied in the patients.
Read the detailed description
Our study is a prospective study that will be conducted in the Emergency Medicine Clinic of Kocaeli City Hospital. Patients aged 18 and above who present to the emergency department of Kocaeli City Hospital with symptoms suggestive of renal colic will be included in the study if they volunteer. After examination by a resident physician working in the emergency department, patients for whom nephrolithiasis is considered among the preliminary diagnoses will be notified to the principal investigators. After obtaining written consent, demographic data, vital signs, and physical examination findings will be recorded on previously prepared standard data forms.
Patients scoring 8 points or higher according to the STONE criteria based on history, physical examination, and laboratory results will undergo bedside ultrasound. The ultrasound will be performed by 4 resident physicians with a basic ultrasound course certificate from the Turkish Emergency Medicine Association, who have 2 years of experience. The bedside urinary ultrasound will be performed using the 'Esaote Mylab Gamma® device (Genoa, Italy)' ultrasound machine with the 'Esaote AC2541 curved array (1-8 MHz) probe (Genoa, Italy)' while the patient is in the supine position.
During renal ultrasound, the convex ultrasound probe will be placed in the right upper quadrant of the patient, intersecting the right lower intercostal area and the mid-axillary line. In the left upper quadrant, the probe will be placed in the lower intercostal area along the posterior axillary line. The ultrasound probe will be positioned longitudinally with the indicator pointing towards the patient's head. Subsequently, the same area will be imaged transversely with the indicator pointing towards the patient's right.
In these sections, images of the kidneys will be evaluated for the presence of hydronephrosis, the degree of expansion of pelvic-calyceal structures, stone size, kidney dimensions, parenchymal echogenicity, and the presence of primary stones or acoustic shadowing from stones. Then, from the suprapubic region, the probe will be positioned transversely and longitudinally, sequentially showing the patient's right and head; the presence of globules in the bladder, bladder dimensions, the presence of stones, and the degree of jet flow at the junction of the ureters with the bladder will be assessed using color frequency mode (CFM). The presence of twinkling artifacts with color frequency mode (CFM) will be evaluated when a stone is suspected. The data obtained will be recorded on the study form by the resident physician performing the ultrasound. The recorded data will later be compared with the gold standard diagnostic method, computed tomography routinely performed in patients with nephrolithiasis, for effectiveness.
- Conditions
- Renal Colic, Stone, Kidney, Hydronephrosis, Nephrolithiasis
- Being tested
- Renal Ultrasonography
- Keywords
- POCUS, STONE, Renal Colic, Nephrolithiasis
- Medical subject headings
- Renal Colic, Kidney Calculi, Hydronephrosis, Nephrolithiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Renal UltrasonographyDiagnostic test
Also called STONE criteria
To investigate the primary and secondary signs of stones with ultrasound and to additionally use the Stone criteria in patients with suspected nephrolithiasis.
What is being measured
The primary outcome is the main question the study is designed to answer.
Nephrolithiasis diagnostic accuracy
Adding bedside focused ultrasonography to the STONE criteria increases diagnostic accuracy in patients presenting to the emergency department with a preliminary diagnosis of nephrolithiasis.
Measured: 2 year
Secondary outcomes (2)
Predicting the possible complications
The success of using POCUS in predicting possible complications in patients with nephrolithiasis.
Measured: 2 year
Readmission to hospital.
Predicting hospital readmission rate within 1 month in patients with nephrolithiasis.
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2025
- Study start1 Feb 2024
- Primary completion30 Apr 2025
- Study completion31 Dec 2025 (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 ColicStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 490 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Kocaeli City Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Asım Enes Özbek, Study director, Kocaeli City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07126847
- Sponsor's protocol ID
- 2023-10
- Acronym
- POCUS
- Status last verified
- Aug 2025
- First submitted
- 27 Mar 2024
- Last updated
- 17 Aug 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Rosen's Emergency Medicine: Concepts and Clinical Practice 10th Edition-June 13, 2022 Authors: Ron Walls, Robert Hockberger, Marianne Gausche-Hill, Timothy B. Erickson, Susan R. Wilcox
Teichman JM, Long RD, Hulbert JC. Long-term renal fate and prognosis after staghorn calculus management. J Urol. 1995 May;153(5):1403-7.
PubMed 7714951Preminger GM, Tiselius HG, Assimos DG, Alken P, Buck C, Gallucci M, Knoll T, Lingeman JE, Nakada SY, Pearle MS, Sarica K, Turk C, Wolf JS Jr; EAU/AUA Nephrolithiasis Guideline Panel. 2007 guideline for the management of ureteral calculi. J Urol. 2007 Dec;178(6):2418-34. doi: 10.1016/j.juro.2007.09.107. No abstract available.
PubMed 17993340Westphalen AC, Hsia RY, Maselli JH, Wang R, Gonzales R. Radiological imaging of patients with suspected urinary tract stones: national trends, diagnoses, and predictors. Acad Emerg Med. 2011 Jul;18(7):699-707. doi: 10.1111/j.1553-2712.2011.01103.x.
PubMed 21762233Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.
PubMed 20008689Moore CL, Carpenter CR, Heilbrun ML, Klauer K, Krambeck AC, Moreno C, Remer EM, Scales C, Shaw MM, Sternberg KM. Imaging in Suspected Renal Colic: Systematic Review of the Literature and Multispecialty Consensus. J Urol. 2019 Sep;202(3):475-483. doi: 10.1097/JU.0000000000000342. Epub 2019 Aug 8.
PubMed 31412438Smith-Bindman R, Aubin C, Bailitz J, Bengiamin RN, Camargo CA Jr, Corbo J, Dean AJ, Goldstein RB, Griffey RT, Jay GD, Kang TL, Kriesel DR, Ma OJ, Mallin M, Manson W, Melnikow J, Miglioretti DL, Miller SK, Mills LD, Miner JR, Moghadassi M, Noble VE, Press GM, Stoller ML, Valencia VE, Wang J, Wang RC, Cummings SR. Ultrasonography versus computed tomography for suspected nephrolithiasis. N Engl J Med. 2014 Sep 18;371(12):1100-10. doi: 10.1056/NEJMoa1404446.
PubMed 25229916Moore CL, Bomann S, Daniels B, Luty S, Molinaro A, Singh D, Gross CP. Derivation and validation of a clinical prediction rule for uncomplicated ureteral stone--the STONE score: retrospective and prospective observational cohort studies. BMJ. 2014 Mar 26;348:g2191. doi: 10.1136/bmj.g2191.
PubMed 24671981
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Success of POCUS Usage in Addition to STONE Criteria in Diagnosing Nephrolithiasis and Predicting Readmission Within One Month in Patients Presenting to the Emergency Department With Suspected Nephrolithiasis
- ClinicalTrials.gov ID
- NCT07126847
- Acronym / sponsor ID
- POCUS / 2023-10
- Conditions
- Renal Colic, Stone, Kidney, Hydronephrosis, Nephrolithiasis
- Keywords
- POCUS, STONE, Renal Colic, Nephrolithiasis
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 490 participants (estimated)
- Lead sponsor
- Kocaeli City HospitalOther government
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 17 Aug 2025 (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 presenting to the emergency department with symptoms suggestive of renal colic will be included in the study at Kocaeli City Hospital's emergency department. Patients with nephrolithiasis considered among the preliminary diagnoses will be enrolled in the study; demographic data, vital signs, and physical examination findings will be recorded on pre-prepared standard data forms.
STONE criteria scores will be calculated by emergency assistants, and bedside ultrasound will be performed for patients. Ultrasonographic findings suggestive of renal colic, such as hydronephrosis, the presence of primary stones, acoustic shadowing of the stone, the presence of twinkle artifact, presence of jet flow, and presence of bladder debris, will be evaluated, and the obtained data will be recorded on the standard data form by the performing assistant physician. In patients where computed tomography, which is the gold standard for detecting stone presence without intervention, is deemed appropriate without any intervention to the primary examining physician, the computed tomography results and ultrasound findings will be compared.
The study aims to evaluate the effectiveness of bedside ultrasound application in diagnosing stone presence in patients, its success in predicting re-admission to the hospital within 1 month, its success in predicting possible alternative diagnoses and complications, in addition to the stone criteria applied in the patients.
Detailed description
Our study is a prospective study that will be conducted in the Emergency Medicine Clinic of Kocaeli City Hospital. Patients aged 18 and above who present to the emergency department of Kocaeli City Hospital with symptoms suggestive of renal colic will be included in the study if they volunteer. After examination by a resident physician working in the emergency department, patients for whom nephrolithiasis is considered among the preliminary diagnoses will be notified to the principal investigators. After obtaining written consent, demographic data, vital signs, and physical examination findings will be recorded on previously prepared standard data forms.
Patients scoring 8 points or higher according to the STONE criteria based on history, physical examination, and laboratory results will undergo bedside ultrasound. The ultrasound will be performed by 4 resident physicians with a basic ultrasound course certificate from the Turkish Emergency Medicine Association, who have 2 years of experience. The bedside urinary ultrasound will be performed using the 'Esaote Mylab Gamma® device (Genoa, Italy)' ultrasound machine with the 'Esaote AC2541 curved array (1-8 MHz) probe (Genoa, Italy)' while the patient is in the supine position.
During renal ultrasound, the convex ultrasound probe will be placed in the right upper quadrant of the patient, intersecting the right lower intercostal area and the mid-axillary line. In the left upper quadrant, the probe will be placed in the lower intercostal area along the posterior axillary line. The ultrasound probe will be positioned longitudinally with the indicator pointing towards the patient's head. Subsequently, the same area will be imaged transversely with the indicator pointing towards the patient's right.
In these sections, images of the kidneys will be evaluated for the presence of hydronephrosis, the degree of expansion of pelvic-calyceal structures, stone size, kidney dimensions, parenchymal echogenicity, and the presence of primary stones or acoustic shadowing from stones. Then, from the suprapubic region, the probe will be positioned transversely and longitudinally, sequentially showing the patient's right and head; the presence of globules in the bladder, bladder dimensions, the presence of stones, and the degree of jet flow at the junction of the ureters with the bladder will be assessed using color frequency mode (CFM). The presence of twinkling artifacts with color frequency mode (CFM) will be evaluated when a stone is suspected. The data obtained will be recorded on the study form by the resident physician performing the ultrasound. The recorded data will later be compared with the gold standard diagnostic method, computed tomography routinely performed in patients with nephrolithiasis, for effectiveness.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Volunteer patients over the age of 18 who applied to the emergency department of Kocaeli City Hospital with renal colic will be included in the study.
Key inclusion criteria (1 listed)
- All volunteer patients
Key exclusion criteria (3 listed)
- Pregnant patients,
- Patients for whom the clinician does not give an indication for computed tomography,
- Patients with a previous history of nephrectomy and kidney transplantation.
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 |
|---|---|---|
| Renal UltrasonographyAlso: STONE criteriaTo investigate the primary and secondary signs of stones with ultrasound and to additionally use the Stone criteria in patients with suspected nephrolithiasis. | Diagnostic test | – |
Primary outcome
Nephrolithiasis diagnostic accuracy
Time frame: 2 year
Adding bedside focused ultrasonography to the STONE criteria increases diagnostic accuracy in patients presenting to the emergency department with a preliminary diagnosis of nephrolithiasis.
2 secondary outcomes
Predicting the possible complications
Time frame: 2 year
Readmission to hospital.
Time frame: 1 month
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2025.
- BackgroundRosen's Emergency Medicine: Concepts and Clinical Practice 10th Edition-June 13, 2022 Authors: Ron Walls, Robert Hockberger, Marianne Gausche-Hill, Timothy B. Erickson, Susan R. Wilcox
- Background: PubMed 7714951Teichman JM, Long RD, Hulbert JC. Long-term renal fate and prognosis after staghorn calculus management. J Urol. 1995 May;153(5):1403-7.
- Background: PubMed 17993340Preminger GM, Tiselius HG, Assimos DG, Alken P, Buck C, Gallucci M, Knoll T, Lingeman JE, Nakada SY, Pearle MS, Sarica K, Turk C, Wolf JS Jr; EAU/AUA Nephrolithiasis Guideline Panel. 2007 guideline for the management of ureteral calculi. J Urol. 2007 Dec;178(6):2418-34. doi: 10.1016/j.juro.2007.09.107. No abstract available.
- Background: PubMed 21762233Westphalen AC, Hsia RY, Maselli JH, Wang R, Gonzales R. Radiological imaging of patients with suspected urinary tract stones: national trends, diagnoses, and predictors. Acad Emerg Med. 2011 Jul;18(7):699-707. doi: 10.1111/j.1553-2712.2011.01103.x.
- Background: PubMed 20008689Berrington de Gonzalez A, Mahesh M, Kim KP, Bhargavan M, Lewis R, Mettler F, Land C. Projected cancer risks from computed tomographic scans performed in the United States in 2007. Arch Intern Med. 2009 Dec 14;169(22):2071-7. doi: 10.1001/archinternmed.2009.440.
- Background: PubMed 31412438Moore CL, Carpenter CR, Heilbrun ML, Klauer K, Krambeck AC, Moreno C, Remer EM, Scales C, Shaw MM, Sternberg KM. Imaging in Suspected Renal Colic: Systematic Review of the Literature and Multispecialty Consensus. J Urol. 2019 Sep;202(3):475-483. doi: 10.1097/JU.0000000000000342. Epub 2019 Aug 8.
- Background: PubMed 25229916Smith-Bindman R, Aubin C, Bailitz J, Bengiamin RN, Camargo CA Jr, Corbo J, Dean AJ, Goldstein RB, Griffey RT, Jay GD, Kang TL, Kriesel DR, Ma OJ, Mallin M, Manson W, Melnikow J, Miglioretti DL, Miller SK, Mills LD, Miner JR, Moghadassi M, Noble VE, Press GM, Stoller ML, Valencia VE, Wang J, Wang RC, Cummings SR. Ultrasonography versus computed tomography for suspected nephrolithiasis. N Engl J Med. 2014 Sep 18;371(12):1100-10. doi: 10.1056/NEJMoa1404446.
- Background: PubMed 24671981Moore CL, Bomann S, Daniels B, Luty S, Molinaro A, Singh D, Gross CP. Derivation and validation of a clinical prediction rule for uncomplicated ureteral stone--the STONE score: retrospective and prospective observational cohort studies. BMJ. 2014 Mar 26;348:g2191. doi: 10.1136/bmj.g2191.
- Individual participant dataSharing planned: Undecided
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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.
Asım Enes Özbek study director
Kocaeli City 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 Colic and Stone, Kidney, run by Kocaeli City Hospital 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 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: under way, not looking for participants, as of the sponsor's last update on 17 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
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?
Nephrolithiasis diagnostic accuracy (time frame: 2 year). 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 NCT07126847, 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 17 Aug 2025.