Kidney CalculiNCT06689683
Fluoroscopy Activation Interval in SWL
A study testing Shock wave lithotripsy in people with Kidney Calculi, run by Lütfi Kırdar City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Shock wave lithotripsy (SWL) is a noninvasive method widely used as the first step in treating stone disease. This study aimed to reduce radiation exposure to patients and practitioners during SWL sessions by extending the intervals of fluoroscopy controls. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Kidney Calculi
- What is being tested?
- Shock wave lithotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 158 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 27 Jul 2020to 5 Jan 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- radiopaque renal pelvic stones smaller than 2 centimeters.
Who cannot join
- anatomical anomalies, coagulation disorders, non-opaque calculi, active urinary infection and distal obstruction
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Science University Kartal Dr. Lütfi Kırdar City Hospital
Istanbul
About this study
Official title: Comparison of Two Different Fluoroscopy Activation Intervals in Shock Wave Lithotripsy: a Prospective Randomised Study
Shock wave lithotripsy (SWL) is a noninvasive method widely used as the first step in treating stone disease. This study aimed to reduce radiation exposure to patients and practitioners during SWL sessions by extending the intervals of fluoroscopy controls. The main questions it aims to answer are:
- Will radiation exposure be reduced?
- Will the stone-free status be affected? The researchers will compare the fluoroscopic control intervals of 250 shocks and 500 shocks.
Participants will:
- Take to a maximum of 3 sessions.
- Check once a week
- Group 1 was fluoroscopically monitored every 250 shocks, and Group 2 was fluoroscopically monitored every 500 shocks
Read the detailed description
SWL works on the principle of focusing on the calculus using ultrasonography or fluoroscopy, transmitting high-energy shock waves from the lithotripter to the calculus and fragmenting it. Fluoroscopic focusing is a commonly used imaging technique that raises concerns about ionizing radiation exposure for patients, technologists, and physicians. Intermittent fluoroscopic monitoring during SWL is widely employed to adjust for patient movement, respiratory movement, and stone displacement within the kidney. However, there is no consensus on the optimal frequency of fluoroscopic monitoring in the literature. This study aims to seek to determine whether increasing the duration between fluoroscopic checks affects the success rate of SWL in achieving stone-free status while reducing radiation exposure to patients.
- Conditions
- Kidney Calculi
- Being tested
- Shock wave lithotripsy
- Keywords
- kidney stone, shock wave lithotripsy, radiation
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Shock wave lithotripsyDevice
SWL works on the principle of focusing on the calculus using fluoroscopy. There has yet to be a consensus on the optimal frequency of fluoroscopic monitoring in the literature.
| Study group | Role | What they receive |
|---|---|---|
| 250 shocks | Active comparator | In our clinic, it is standard practice to perform a fluoroscopic check after every 250 shocks during the SWL session. Group 1 was fluoroscopically monitored every 250 shocks. Receives: Device: Shock wave lithotripsy |
| 500 shocks | Active comparator | Group 2 was fluoroscopically monitored every 500 shocks. Receives: Device: Shock wave lithotripsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate The effect of two different fluoroscopic activation intervals on the stone-free rate.
Session intervals were determined as one week, and patients with residues visible on the KUB radiography before the session were included in the new session. At the end of the treatment, direct radiography and ultrasound of the urinary system was performed at the end of the first month. Patients with stones larger than 4 mm were considered to have had an unsuccessful treatment.
Measured: 1 month after the end of treatment
Secondary outcomes (2)
Secondary endpoints were total fluoroscopy time and complications.
The total fluoroscopy time (seconds) during treatment will be calculated.
Measured: From registration until the 1st month after the end of treatment.
Secondary endpoints were complications.
Complications occurring from the beginning of treatment to the end of treatment, such as additional intervention, pyelonephritis, steinstrausse.
Measured: From registration until the 1st month after the end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2024
- Study start27 Jul 2020
- Primary completion5 Jan 2024
- Study completion5 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney CalculiStudies 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
- Masking
- None (open label)
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lütfi Kırdar City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cengiz Canakcı, MD, Saglik Bilimleri Universitesi
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06689683
- Sponsor's protocol ID
- Canakci0001
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 14 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Two Different Fluoroscopy Activation Intervals in Shock Wave Lithotripsy: a Prospective Randomised Study
- ClinicalTrials.gov ID
- NCT06689683
- Acronym / sponsor ID
- Canakci0001
- Conditions
- Kidney Calculi
- Keywords
- kidney stone, shock wave lithotripsy, radiation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- Lütfi Kırdar City HospitalUniversity, hospital or other
- Study start
- 27 Jul 2020 (actual)
- Primary completion
- 5 Jan 2024 (actual)
- Study completion
- 5 Jan 2024 (actual)
- First posted
- 14 Nov 2024 (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.
Shock wave lithotripsy (SWL) is a noninvasive method widely used as the first step in treating stone disease. This study aimed to reduce radiation exposure to patients and practitioners during SWL sessions by extending the intervals of fluoroscopy controls. The main questions it aims to answer are:
- Will radiation exposure be reduced?
- Will the stone-free status be affected? The researchers will compare the fluoroscopic control intervals of 250 shocks and 500 shocks.
Participants will:
- Take to a maximum of 3 sessions.
- Check once a week
- Group 1 was fluoroscopically monitored every 250 shocks, and Group 2 was fluoroscopically monitored every 500 shocks
Detailed description
SWL works on the principle of focusing on the calculus using ultrasonography or fluoroscopy, transmitting high-energy shock waves from the lithotripter to the calculus and fragmenting it. Fluoroscopic focusing is a commonly used imaging technique that raises concerns about ionizing radiation exposure for patients, technologists, and physicians. Intermittent fluoroscopic monitoring during SWL is widely employed to adjust for patient movement, respiratory movement, and stone displacement within the kidney. However, there is no consensus on the optimal frequency of fluoroscopic monitoring in the literature. This study aims to seek to determine whether increasing the duration between fluoroscopic checks affects the success rate of SWL in achieving stone-free status while reducing radiation exposure to patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 250 shocks | Active comparator | Device: Shock wave lithotripsyIn our clinic, it is standard practice to perform a fluoroscopic check after every 250 shocks during the SWL session. Group 1 was fluoroscopically monitored every 250 shocks. |
| 500 shocks | Active comparator | Device: Shock wave lithotripsyGroup 2 was fluoroscopically monitored every 500 shocks. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- radiopaque renal pelvic stones smaller than 2 centimeters.
Key exclusion criteria (1 listed)
- anatomical anomalies, coagulation disorders, non-opaque calculi, active urinary infection and distal obstruction
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 |
|---|---|---|
| Shock wave lithotripsySWL works on the principle of focusing on the calculus using fluoroscopy. There has yet to be a consensus on the optimal frequency of fluoroscopic monitoring in the literature. | Device | 250 shocks, 500 shocks |
Primary outcome
evaluate The effect of two different fluoroscopic activation intervals on the stone-free rate.
Time frame: 1 month after the end of treatment
Session intervals were determined as one week, and patients with residues visible on the KUB radiography before the session were included in the new session. At the end of the treatment, direct radiography and ultrasound of the urinary system was performed at the end of the first month. Patients with stones larger than 4 mm were considered to have had an unsuccessful treatment.
2 secondary outcomes
Secondary endpoints were total fluoroscopy time and complications.
Time frame: From registration until the 1st month after the end of treatment.
Secondary endpoints were complications.
Time frame: From registration until the 1st month after the end of treatment.
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 14 Nov 2024.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Shock wave lithotripsy in people with Kidney Calculi, run by Lütfi Kırdar 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 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: finished, as of the sponsor's last update on 14 Nov 2024. 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?
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?
evaluate The effect of two different fluoroscopic activation intervals on the stone-free rate. (time frame: 1 month after the end of treatment). 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 14 Nov 2024.