Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:01 PM
Ignite Modification Date:
2025-12-24 @ 10:01 PM
NCT ID:
NCT07299032
Eligibility Criteria:
Inclusion Criteria:
* Pediatric patients aged 0 to 14 years with a confirmed diagnosis of upper urinary tract stones.
* Diagnosis confirmed by ultrasound or low-dose CT; stone long diameter ≤ 20 mm (for upper ureteral stones, diameter ≤ 15 mm); absence of urinary tract structural malformations.
* Meeting the indications for ESWL with no absolute contraindications, and scheduled to undergo ESWL treatment.
* Guardians provide informed consent and voluntarily sign the written informed consent form; willing and able to cooperate with the 4-week postoperative follow-up and related examinations.
* Preoperative assessment reveals no contraindications to ESWL, such as uncontrolled infection, severe coagulation disorders, or severe impairment of cardiopulmonary, hepatic, or renal function.
Exclusion Criteria:
* Presence of absolute contraindications for ESWL: Uncontrolled severe urinary tract infection or sepsis; severe uncorrected coagulopathy or current use of anticoagulant/antiplatelet medications; severe renal impairment (significantly decreased GFR); active severe cardiopulmonary disease rendering the patient unable to tolerate anesthesia or shock wave therapy; or absence of an anatomically safe shock wave path (e.g., due to severe skeletal deformities).
* Stones suspected to be extremely hard or complex: Refractory stones indicated by excessively high CT Hounsfield Units (HU) or ultrasound Shear Wave Elastography (SWE) values \> 13.7 kPa; or cystine stones in children \> 2 years of age (associated with significantly low ESWL success rates).
* Anatomical or physiological challenges: Severe obesity that compromises ultrasound localization; or patients with a solitary kidney or poor contralateral renal function accompanied by a large stone burden.
* Prior intervention: History of prior ESWL or other lithotripsy procedures at the target site, which may confound the evaluation of therapeutic efficacy.
* Underlying systemic conditions: Comorbid severe metabolic diseases or hereditary stone diseases (e.g., cystinuria) requiring priority comprehensive management.
* Compliance issues: Guardians unable to cooperate with the complete follow-up process, or patients with a high anticipated risk of being lost to follow-up.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
0 Months
Maximum Age:
14 Years
Study:
NCT07299032
Study Brief:
Protocol Section:
NCT07299032