Ultraslow SWL Versus Slow SWL for Ureteric Stones With High Attenuation Value

NCT ID: NCT03795545

Last Updated: 2019-12-10

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

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

101 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-11

Study Completion Date

2019-08-12

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Ultraslow full-power SWL versus slow power-ramping SWL in ureteric stones with high attenuation value

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

To evaluate the efficacy of ultraslow rate of SWL versus slow rate, power ramping SWL

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ureteric Stone

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

ureteric stone SWL High density stones Ultraslow SWL Slow SWL Ramping Pause

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Ultraslow shock wave lithotripsy (SWL)

SWL at ultraslow rate of 30 SW/min. Power ramping at the first 100 SW from 6 to 18 kv followed by safety pause for two minutes then power ramping from 18 to 22kv during the second 100 SW followed by safety pause for another two minutes.

The rest of the session at 22kv (full power).

Group Type ACTIVE_COMPARATOR

SWL

Intervention Type PROCEDURE

Shock wave lithotripsy

Slow power-ramping SWL

SWL at a slow rate of 60 SW/min. Power ramping from 6 - 10 kv during the first 500 SW then from 11 - 14 kv during the second 500 SW then from 15 - 18 kv during the following 500 SW then from 19 - 22 kv during the remaining 1000 - 1500 SW.

Group Type ACTIVE_COMPARATOR

SWL

Intervention Type PROCEDURE

Shock wave lithotripsy

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

SWL

Shock wave lithotripsy

Intervention Type PROCEDURE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

ESWL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* single upper ureteric stone less than or equal to 2 cm
* radio-opaque stone
* high attenuation value (≥ 1000 HU) stone

Exclusion Criteria

* Abnormal renal anatomy
* renal insufficiency
* solitary kidney
* coagulopathies
* uncontrolled hypertension
* renal artery or aortic aneurysm
* active urinary tract infection
* pregnancy
* severe skeletal malformations (spinal deformity) precluding proper stone localization
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Beni-Suef University

OTHER

Sponsor Role collaborator

Cairo University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Mohammed Said ElSheemy

Associate Professor of Urology

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Ahmad Aref Al-Dessoukey, Ass. Prof.

Role: STUDY_DIRECTOR

Beni-Suef University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Beni-Suef Hospitals

Banī Suwayf, Outside U.S./Canada, Egypt

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

16231

Identifier Type: -

Identifier Source: org_study_id