A pilot study in a single center for comparison of stone-fragmentation rate of ESWL (extracorporeal shock-wave lithotripsy) with ElectroHydraulic (EH) method between foreign and domestic products.

A prospective, randomized, open-label, pilot study in a single center for comparison of stone-fragmentation rate of ESWL (extracorporeal shock-wave lithotripsy) with ElectroHydraulic (EH) method between foreign and domestic products.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

CRIS

Registry ID

KCT0005298

Enrollment

Registered

2020-08-07

Start date

2020-08-10

Completion date

Unknown

Last updated

2020-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Medical Device : With an exploratory study comparing the performance and safety of procedures between domestic Rifle® products of test group in vitro impact cracking machine and EDAP® products of acti

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -Patients over 20 years of age who need ESWL due to symptoms or changes in the size of the stones. -Absence located in the upper kidney and kidney in the 5-15mm ureter or kidney. (Mid or lower uncles are excluded). -According to the guidelines of the European Urological Association, when stones are growing, there is a high risk of recurrence of stones, urinary tract obstruction due to stones, and if there are symptoms related to stones such as urinary tract infection, hematuria and pain, the size of the stones is greater than 15 mm. If it is smaller than 20mm, the size of the stone is small, but it is difficult to follow up, the patient's preference, the presence and type of underlying disease, social situation such as occupation or travel, and the absence lasting more than 2-3 years-double in vitro The case where only shock crushing stone is not considered is the case of 20mm or more in the kidney, especially in the lower kidney calyx, 15mm is considered as the upper limit, and endoscopic surgery is more preferred due to the low treatment success rate.

Exclusion criteria

Exclusion criteria: If the size of the stone is over 15mm -Musculoskeletal malformations -In case urinary tract infection is progressing, infection treatment is the priority -In case of high risk of invasive procedure due to blood clotting disease -When it is difficult to discharge stones due to ureteral stenosis

Design outcomes

Primary

Measure	Time frame
There is no residual stone or 3 mm or less observed in CT scan	—

Secondary

Measure	Time frame
There is no residual stone or 3 mm or less observed in CT scan	—

Countries

Korea, Republic of

Contacts

Public ContactSung Cho

Seoul National University Hospital

Outcome results