Ureteral Stones, Kidney StonesNCT02210650
Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney
A study testing Symptomatic stone removal and Asymptomatic kidney stones and ureteral stone removed in people with Ureteral Stones, Kidney Stones, run by Indiana Kidney Stone Institute at 4 sites in United States.
Trial summary
Patients with a ureteral or kidney stone that causes symptoms, like pain, frequently have small kidney stones that don't cause symptoms. If these small kidney stones are determined to be asymptomatic (not causing any problems or pain), then most urologists will simply remove the symptomatic ureteral stone and leave… Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Ureteral Stones, Kidney Stones
- What is being tested?
- Symptomatic stone removal and Asymptomatic kidney stones and ureteral stone removed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 4 sitesUnited States
- Study dates
- Nov 2014to May 2022
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Scheduled to undergo surgery (URS or PCNL) for a primary stone.
- Computed tomography (CT) exam within the 90-day pre-operative period
- Small (≤ 6mm) asymptomatic stones in visible on KUB or CT (i.e., calcium stones) in the contralateral kidney for a primary renal stone or ipsilateral kidney for primary ureteral stone.
- Recurrent (having had previous stones) or multiple (simultaneous bilateral stones) stones
- Able to give informed consent
- Age 21 years or older
Who cannot join
- Inability to give informed consent
- Age less than 21 years
- Stones not visible on KUB or CT
- Patients with systemic disease or renal anatomical disorders (RTA, primary hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)
- Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the
- subject at significant risk, confound the study results, or interfere significantly with the subject's
- participation in the study.
- Unwilling to participate.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Indiana University Health
Indianapolis, Indiana, 46202
University of Minnesota
Minneapolis, Minnesota, 55455
University of Washington Medical Center Department of Urology
Seattle, Washington, 98195 9472
Veterans Administration Puget Sound Heath Care System
Seattle, Washington, 98195
About this study
Official title: Randomized Controlled Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney
Patients with a ureteral or kidney stone that causes symptoms, like pain, frequently have small kidney stones that don't cause symptoms. If these small kidney stones are determined to be asymptomatic (not causing any problems or pain), then most urologists will simply remove the symptomatic ureteral stone and leave the additional stones in the kidneys. However, symptomatic kidney stones started as small stones that didn't cause symptoms. This means that the small stones remaining in the patient's kidney may cause problems later. The purpose of our research is to test if removing small stones from the kidney prevents future stone episodes.
- Conditions
- Ureteral Stones, Kidney Stones
- Being tested
- Symptomatic stone removal, Asymptomatic kidney stones and ureteral stone removed
- Keywords
- kidney stone
- Medical subject headings
- Kidney Calculi
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Symptomatic stone removalProcedure or surgery
Symptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy
Asymptomatic kidney stones and ureteral stone removedProcedure or surgery
Asymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy
| Study group | Role | What they receive |
|---|---|---|
| Symptomatic stone removal | Other | Group 1 will receive the standard treatment of having only the symptomatic stone removed Receives: Procedure: Symptomatic stone removal |
| Asymptomatic kidney stones and symptomatic stone removed | Other | Group 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone Receives: Procedure: Asymptomatic kidney stones and ureteral stone removed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relapse of stone disease on the study side
- Radiological evidence of significant growth in the size of any pre-existing stone
- Return for stone removal surgery on the study side
- Passage of a stone with pain symptoms on the study side resulting in an emergency department visit
Measured: annually up to 5 years after stone removal surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2014 (estimated)
- Study startNov 2014
- Primary completionMay 2022
- Study completionMay 2022
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 Ureteral Stones, Kidney StonesStudies 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
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana Kidney Stone Institute
- Sponsor type
- University, hospital or other
- Collaborators
- University of Washington, VA Puget Sound Health Care System
- Responsible party
- Sponsor
- Investigators
- James E Lingeman, MD, Principal investigator, Indiana University Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02210650
- Sponsor's protocol ID
- P01 DK 043881 Project 3
- Other IDs
- P01DK043881
- Status last verified
- May 2022
- First submitted
- 1 Aug 2014
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sorensen MD, Harper JD, Borofsky MS, Hameed TA, Smoot KJ, Burke BH, Levchak BJ, Williams JC Jr, Bailey MR, Liu Z, Lingeman JE. Removal of Small, Asymptomatic Kidney Stones and Incidence of Relapse. N Engl J Med. 2022 Aug 11;387(6):506-513. doi: 10.1056/NEJMoa2204253.
PubMed 35947709
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Relapse Rates Between Standard Ureteroscopic Removal Of Ureteral Stone And Standard Removal With Additional Ureterorenic Clearing Of Non-Symptomatic Stones In The Kidney
- ClinicalTrials.gov ID
- NCT02210650
- Acronym / sponsor ID
- P01 DK 043881 Project 3
- Conditions
- Ureteral Stones, Kidney Stones
- Keywords
- kidney stone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Indiana Kidney Stone InstituteUniversity, hospital or other
- Collaborators
- University of Washington, VA Puget Sound Health Care System
- Study start
- Nov 2014
- Primary completion
- May 2022 (actual)
- Study completion
- May 2022 (actual)
- First posted
- 7 Aug 2014 (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.
Patients with a ureteral or kidney stone that causes symptoms, like pain, frequently have small kidney stones that don't cause symptoms. If these small kidney stones are determined to be asymptomatic (not causing any problems or pain), then most urologists will simply remove the symptomatic ureteral stone and leave the additional stones in the kidneys. However, symptomatic kidney stones started as small stones that didn't cause symptoms. This means that the small stones remaining in the patient's kidney may cause problems later. The purpose of our research is to test if removing small stones from the kidney prevents future stone episodes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Symptomatic stone removal | Other | Procedure: Symptomatic stone removalGroup 1 will receive the standard treatment of having only the symptomatic stone removed |
| Asymptomatic kidney stones and symptomatic stone removed | Other | Procedure: Asymptomatic kidney stones and ureteral stone removedGroup 2 will include the step of having the asymptomatic kidney stones removed in addition to the symptomatic stone |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Scheduled to undergo surgery (URS or PCNL) for a primary stone.
- Computed tomography (CT) exam within the 90-day pre-operative period
- Small (≤ 6mm) asymptomatic stones in visible on KUB or CT (i.e., calcium stones) in the contralateral kidney for a primary renal stone or ipsilateral kidney for primary ureteral stone.
- Recurrent (having had previous stones) or multiple (simultaneous bilateral stones) stones
- Able to give informed consent
Key exclusion criteria (8 listed)
- Inability to give informed consent
- Age less than 21 years
- Stones not visible on KUB or CT
- Patients with systemic disease or renal anatomical disorders (RTA, primary hyperparathyroidism, sarcoidosis, enteric hyperoxaluria, medullary sponge kidney)
- Any condition (eg, psychiatric illness) or situation that, in the investigator's opinion, could put the
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 |
|---|---|---|
| Symptomatic stone removalSymptomatic stone removal by the surgical procedures called Ureteroscopy or Percutaneous Nephrolithotomy | Procedure or surgery | Symptomatic stone removal |
| Asymptomatic kidney stones and ureteral stone removedAsymptomatic kidney stones and symptomatic stone removal by the surgical procedure called Ureteroscopy | Procedure or surgery | Asymptomatic kidney stones and symptomatic stone removed |
Primary outcome
Relapse of stone disease on the study side
Time frame: annually up to 5 years after stone removal surgery
1. Radiological evidence of significant growth in the size of any pre-existing stone 2. Return for stone removal surgery on the study side 3. Passage of a stone with pain symptoms on the study side resulting in an emergency department visit
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 25 May 2022.
- Derived from this study: PubMed 35947709Sorensen MD, Harper JD, Borofsky MS, Hameed TA, Smoot KJ, Burke BH, Levchak BJ, Williams JC Jr, Bailey MR, Liu Z, Lingeman JE. Removal of Small, Asymptomatic Kidney Stones and Incidence of Relapse. N Engl J Med. 2022 Aug 11;387(6):506-513. doi: 10.1056/NEJMoa2204253.
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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.
James E Lingeman, MD principal investigator
Indiana University Health
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Symptomatic stone removal and Asymptomatic kidney stones and ureteral stone removed in people with Ureteral Stones, Kidney Stones, run by Indiana Kidney Stone Institute at 4 sites in United States.
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 6 inclusion and 8 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 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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?
Relapse of stone disease on the study side (time frame: annually up to 5 years after stone removal surgery). 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 NCT02210650, 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 25 May 2022.