NephrolithiasisPhase 4NCT02430883
Is There Any Relation Between Pain and Stone Location in Retrograde Intrarenal Surgery?
A Phase 4 study testing Retrograde Intrarenal Surgery in people with Nephrolithiasis, run by Diskapi Teaching and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
We want to serach the relationship between the pain degree and stone localisation in kidney in Retrograde intrarenal surgery Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Nephrolithiasis
- What is being tested?
- Retrograde Intrarenal Surgery
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2015to Jan 2016
- Phase
- Phase 4
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing RIRS Age between 18 and 90 years
Who cannot join
- Patients who have congenital urogenital abnormalities 2)Patients who have previous surgery history
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Dıskapı TRH
Ankara, 06110
Nihat Karakoyunlu, MD, 00905324747134, nkarakoyunlu@gmail.com
Nihat Karakoyunlu, MD
About this study
We want to serach the relationship between the pain degree and stone localisation in kidney in Retrograde intrarenal surgery
- Conditions
- Nephrolithiasis
- Being tested
- Retrograde Intrarenal Surgery
- Keywords
- pain, RIRS, kidney
- Medical subject headings
- Nephrolithiasis, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Retrograde Intrarenal SurgeryProcedure or surgery
endoscopic treatment of kidney stones with flexible renoscopy
| Study group | Role | What they receive |
|---|---|---|
| first group | Active comparator | patients who have upper pole kidney stones treated with flexible renoscopy Receives: Procedure: Retrograde Intrarenal Surgery |
| second group | Active comparator | patients u who have mid pole kidney stones treated with flexible renoscopy Receives: Procedure: Retrograde Intrarenal Surgery |
| third group | Active comparator | patients who have lower pole kidney stones treated with flexible renoscopy Receives: Procedure: Retrograde Intrarenal Surgery |
| forth group | Active comparator | patients who have kidney stones in pelvis treated with flexible renoscopy Receives: Procedure: Retrograde Intrarenal Surgery |
| fifth group | Active comparator | patients who have multiple calixes kidney stones treated with flexible renoscopy Receives: Procedure: Retrograde Intrarenal Surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain degree
Measured: Pain degree postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2015 (estimated)
- Study startJan 2015
- Primary completionDec 2015 (estimated)
- Study completionJan 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for NephrolithiasisStudies 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 4
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Diskapi Teaching and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nihat Karakoyunlu, Diskapi Teaching and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02430883
- Sponsor's protocol ID
- 15.12.2014 18/15
- Status last verified
- Apr 2015
- First submitted
- 27 Apr 2015
- Last updated
- 30 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Polito C, La Manna A, Signoriello G, Marte A. Recurrent abdominal pain in childhood urolithiasis. Pediatrics. 2009 Dec;124(6):e1088-94. doi: 10.1542/peds.2009-0825. Epub 2009 Nov 9.
PubMed 19901004
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is There Any Relation Between Pain and Stone Location in Retrograde Intrarenal Surgery?
- ClinicalTrials.gov ID
- NCT02430883
- Acronym / sponsor ID
- 15.12.2014 18/15
- Conditions
- Nephrolithiasis
- Keywords
- pain, RIRS, kidney
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Diskapi Teaching and Research HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Jan 2016 (estimated)
- First posted
- 30 Apr 2015 (estimated)
- 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.
We want to serach the relationship between the pain degree and stone localisation in kidney in Retrograde intrarenal surgery
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| first group | Active comparator | Procedure: Retrograde Intrarenal Surgerypatients who have upper pole kidney stones treated with flexible renoscopy |
| second group | Active comparator | Procedure: Retrograde Intrarenal Surgerypatients u who have mid pole kidney stones treated with flexible renoscopy |
| third group | Active comparator | Procedure: Retrograde Intrarenal Surgerypatients who have lower pole kidney stones treated with flexible renoscopy |
| forth group | Active comparator | Procedure: Retrograde Intrarenal Surgerypatients who have kidney stones in pelvis treated with flexible renoscopy |
| fifth group | Active comparator | Procedure: Retrograde Intrarenal Surgerypatients who have multiple calixes kidney stones treated with flexible renoscopy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing RIRS Age between 18 and 90 years
Key exclusion criteria (1 listed)
- Patients who have congenital urogenital abnormalities 2)Patients who have previous surgery history
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 |
|---|---|---|
| Retrograde Intrarenal Surgeryendoscopic treatment of kidney stones with flexible renoscopy | Procedure or surgery | fifth group, first group, forth group, second group, third group |
Primary outcome
Pain degree
Time frame: Pain degree postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2015.
- Results publication: PubMed 19901004Polito C, La Manna A, Signoriello G, Marte A. Recurrent abdominal pain in childhood urolithiasis. Pediatrics. 2009 Dec;124(6):e1088-94. doi: 10.1542/peds.2009-0825. Epub 2009 Nov 9.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Retrograde Intrarenal Surgery in people with Nephrolithiasis, run by Diskapi Teaching and Research 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: status not confirmed, as of the sponsor's last update on 30 Apr 2015. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain degree (time frame: Pain degree postoperative 24 hours). 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 NCT02430883, which also lists 1 linked publication.
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 30 Apr 2015.