What this study is
The aims of the Observational Approach versus Surgical Intervention for Asymptomatic Stone (OASIS) trial are: 1) to determine whether observation compared to upfront surgery results in less healthcare-related life disruption due to kidney stones among children and adults with asymptomatic kidney stones; 2) to identify the groups benefiting the most from each strategy; and 3) to determine the preferences and values informing the choice between observation and upfront surgery.
What's being tested
- Surgery
Intervention · PROCEDURE
Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.
- Observation
Intervention · OTHER
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.
Study details
- Sponsor
- Children's Hospital of Philadelphia
- Conditions
- Nephrolithiasis · Kidney Stone
- Enrolling
- 1,658 people
- Starts
- 2026-08-17
- Est. completion
- 2032-10-01
- Design
- Single-blind, randomized, parallel groups
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 6 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Individuals age 6 or older
- Diagnosis of kidney stone disease (nephrolithiasis)
- Asymptomatic, non-obstructive kidney stones measuring 4 to 10 mm (inclusive); Asymptomatic is defined as the absence of abdominal pain, flank pain, gross hematuria, and nausea and/or vomiting in the last 3 months that in the judgement of the site PI could be attributable to kidney stones.; Non-obstructive is defined as a stone in a renal calyx or stones in multiple renal calyces on CT, ultrasound, and/or x-ray obtained within 6 months of screening.
- Informed consent and if appropriate, child assent.
- Willingness to be randomized to surgery or observation Note: subjects otherwise eligible who decline randomization may be enrolled in a parallel observational cohort.
- Fluent in English or Spanish
- Willingness to be audio- and/or video- recorded during interviews
You can't join if
- Untreated hydronephrosis or caliectasis
- Pain (e.g., renal colic, abdominal pain) or gross hematuria attributed to kidney stones.
- Recurrent symptomatic urinary tract infections (≥3 in 12 months or ≥2 in 6 months). A symptomatic urinary tract infection is defined as having at least one bladder or voiding symptom (e.g., frequency, urgency, dysuria) with bacteriuria (≥105 colony forming units/mL of no more than 2 urinary tract pathogens).
- Stone in the renal pelvis, ureter, bladder or urethra
- Pregnant females
- Solitary kidney, transplant kidney, urinary diversion, medullary sponge kidney
- Anatomic abnormality of the kidney (e.g., horseshoe kidney)
- Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (4)
4 openUniversity of California, Irvine
Irvine, California, United States
- Ryan Hsi, MD · Contact657-579-4535rhsi1@hs.uci.edu
- Roshan Patel, MD · Sub-investigator
- Pengbo Jiang, MD · Sub-investigator
RecruitingUniversity of Minnesota
Minneapolis, Minnesota, United States
- Vishnuvardhan Ganesan, MD · Contact612-625-7486ganes119@umn.edu
- Judith Graziano, RN, PhD · Contact(612) 625-2667grazi005@umn.edu
Not yet recruitingColumbia University Medical Center
New York, New York, United States
- OJas Shah, MD · Contact212-342-6059os2302@cumc.columbia.edu
- Ezra Margolin, MD · Principal investigator
Not yet recruitingThe Children's Hospital of Philadelphia
Hatboro, Pennsylvania, United States
- Rebecca D McCune, BS, MS · Contact267-909-6030mccuner@chop.edu
- Brian Augelli, BS · Contact609-504-4908augellib@chop.edu
- Gregory E Tasian, MD, MSc, MSCE · Principal investigator
Recruiting
Study team
Sponsor
Children's Hospital of Philadelphia
Study ID 26-024242
Principal investigator
Gregory E Tasian, MD, MSc, MSCE
Children's Hospital of Philadelphia
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.