Recruiting

Observation vs. Surgery

Sponsor:

Children's Hospital of Philadelphia

Code:

NCT07718802

Conditions

Nephrolithiasis

Kidney Stone

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

Interventions

Surgery

Observation

Study Details

Brief summary:

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.

Conditions

Nephrolithiasis

Kidney Stone

Study ID

NCT07718802

Start date

Aug 17, 2026

Status verified date

Sep, 2026

Completion date

Oct 1, 2032

Anticipated

Primary completion date

May 31, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 6+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

1658 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: Non-Randomized (Observational)

active comparator: Randomized

Interventions

Surgery

Upfront surgery is the planned removal of asymptomatic stones and includes ureteroscopy and shockwave lithotripsy, which are routinely used in standard clinical care.

Observation

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

Primary outcome measure

  • Healthcare-related life disruption [ Time Frame: Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months. ]

Central Contacts and Locations

Central contacts

Rebecca D McCune, BS, MS

267-909-6030mccuner@chop.edu

Locations

The Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Principal Investigator:

Gregory E Tasian, MD, MSc, MSCE

More Information

Sponsor

Children's Hospital of Philadelphia

Last update posted

Sep 3, 2026

Last verified

Sep, 2026

Keywords

  • kidney stones
  • kidney
  • nephrolithiasis
  • Comparative Effectiveness
  • Patient Reported Outcomes

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Children's Hospital of Philadelphia on 2026-09-03.