Extracorporeal Shockwave Lithotripsy, Electroconductive and Electrohydraulic Types

NCT ID: NCT06144372

Last Updated: 2023-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-03-31

Study Completion Date

2023-05-16

Brief Summary

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To evaluate the efficacy and safety of electroconductive (EC) and electrohydraulic (EH) extracorporeal shock wave lithotripsy (ESWL) for the treatment of ureter and kidney stones, this study conducted a randomized controlled trial.

Detailed Description

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Conditions

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Urolithiasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Electroconductive Type

Sonolith i-moveĀ® shockwave lithotripter (EDAP, Lyon, France)

Group Type OTHER

Electroconductive and Electrohydraulic types

Intervention Type DEVICE

The patients were randomly assigned to two types of lithotripter.

Electrohydraulic Type

Rifle lithotripter (HNT Medical, Seoul, Korea)

Group Type OTHER

Electroconductive and Electrohydraulic types

Intervention Type DEVICE

The patients were randomly assigned to two types of lithotripter.

Interventions

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Electroconductive and Electrohydraulic types

The patients were randomly assigned to two types of lithotripter.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* The analysis included cases of stones in the upper kidney and ureter, with diameters ranging from 5 mm to 15 mm.

Exclusion Criteria

* Patients with musculoskeletal deformities, ongoing urinary tract infections requiring prioritized infection treatment, blood clotting disorders, and ureteral obstruction that made stone expulsion difficult were excluded from the study.
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Sung Yong Cho

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Motolova M, Kral M. Effect of targeting and generator type on efficacy of extracorporeal shock wave lithotripsy. Biomed Pap Med Fac Univ Palacky Olomouc Czech Repub. 2022 Dec;166(4):434-440. doi: 10.5507/bp.2022.029. Epub 2022 Jun 27.

Reference Type BACKGROUND
PMID: 35801399 (View on PubMed)

Other Identifiers

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ESWL_ECEH

Identifier Type: -

Identifier Source: org_study_id