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Observational Approach Versus Surgical Intervention for Stones

Sponsor: Children's Hospital of Philadelphia • ClinicalTrials.gov ID: NCT07718802

Registry updated: 2026-10-15

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Description

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.

Interventions

Surgery (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 (Other)
Observation is the surveillance of asymptomatic stones with periodic CT, ultrasound, or x-ray, and clinic visits.

Eligibility criteria

Inclusion Criteria: 1. Individuals age 6 or older 2. Diagnosis of kidney stone disease (nephrolithiasis) 3. 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. 4. Informed consent and if appropriate, child assent. 5. Willingness to be randomized to surgery or observation Note: subjects otherwise eligible who decline randomization may be enrolled in a parallel observational cohort. 6. Fluent in English or Spanish 7. Willingness to be audio- and/or video- recorded during interviews Exclusion Criteria: 1. Untreated hydronephrosis or caliectasis 2. Pain (e.g., renal colic, abdominal pain) or gross hematuria attributed to kidney stones. 3. 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). 4. Stone in the renal pelvis, ureter, bladder or urethra 5. Pregnant females 6. Solitary kidney, transplant kidney, urinary diversion, medullary sponge kidney 7. Anatomic abnormality of the kidney (e.g., horseshoe kidney) 8. Parents/guardians or subjects who, in the opinion of the Investigator, may be non-compliant with study schedules or procedures

Conditions

Nephrolithiasis Kidney Stone

Locations

University of California, Irvine — Irvine, California, United States
University of Minnesota — Minneapolis, Minnesota, United States
Columbia University Medical Center — New York, New York, United States
The Children's Hospital of Philadelphia — Hatboro, Pennsylvania, United States

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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