NCT07718802

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,658

participants targeted

Target at P75+ for not_applicable

Timeline
75mo left

Started Aug 2026

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 22, 2026

Completed
10 days until next milestone

Study Start

First participant enrolled

August 1, 2026

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 31, 2031

Expected
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2032

Last Updated

July 22, 2026

Status Verified

July 1, 2026

Enrollment Period

4.8 years

First QC Date

July 16, 2026

Last Update Submit

July 16, 2026

Conditions

NephrolithiasisKidney Stone

Keywords

kidney stoneskidneynephrolithiasisComparative EffectivenessPatient Reported Outcomes

Outcome Measures

Primary Outcomes (1)

  • Healthcare-related life disruption

    Composite of: Stone-specific emergency department (ED)/urgent care visits, stone-specific hospitalizations and surgery for stones for new symptoms (Shockwave Lithotripsy (SWL) and Ureteroscopy (URS)) as reported via Patient Centered Outcomes Research Network (PCORnet) Common Data Model (CDM) query and participant self-report on REDCap.

    Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

Secondary Outcomes (7)

  • Patient reported physical and emotional health (Pain Interference)

    Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

  • Patient reported physical and emotional health (Anxiety)

    Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

  • Patient reported physical and emotional health (Stone Quality of Life)

    Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

  • Stone passage

    Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months. Reporting total after 2 years.

  • Lost productivity (Missed School)

    Every 3 months (+/- 14 days) from date of consent (observational cohort) or randomization (randomized cohort) until 24 months.

  • +2 more secondary outcomes

Study Arms (2)

Non-Randomized (Observational)

ACTIVE COMPARATOR
Procedure: SurgeryOther: Observation

Randomized

ACTIVE COMPARATOR
Procedure: SurgeryOther: Observation

Interventions

SurgeryPROCEDURE

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

Non-Randomized (Observational)Randomized
ObservationOTHER

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

Non-Randomized (Observational)Randomized

Eligibility Criteria

Age6 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You 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 may not qualify 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

NephrolithiasisKidney Calculi

Interventions

Surgical Procedures, OperativeObservation

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital DiseasesUrinary CalculiCalculiPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

MethodsInvestigative Techniques

Study Officials

  • Gregory E Tasian, MD, MSc, MSCE

    Children's Hospital of Philadelphia

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Rebecca D McCune, BS, MS

CONTACT

267-909-6030mccuner@chop.edu

Brian J Augelli, BS

CONTACT

609-504-4908augellib@chop.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Allocation concealment will be achieved by having the randomization performed centrally at the Data Coordinating Center (DCC) in REDCap, with randomly permuted blocks of 4, 6, and 8 to minimize the risk of allocation bias. Additionally, we will require participant details to be entered into the system before the randomly allocated treatment is revealed. Blinding will not be possible for participants or investigators providing the treatment (observation or upfront surgery). Members of the Outcome Adjudication Committee will be blinded to group assignment. The principal investigators will not have access to participant level information.
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2026

First Posted

July 22, 2026

Study Start

August 1, 2026

Primary Completion (Estimated)

May 31, 2031

Study Completion (Estimated)

October 1, 2032

Last Updated

July 22, 2026

Record last verified: 2026-07

Locations

US(1)