NCT03939325

Brief Summary

The impact of different frequencies on pattern of disintegration of renal stones

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2019

Status
unknown

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2019

Completed
2 days until next milestone

Study Start

First participant enrolled

May 5, 2019

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 6, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

May 6, 2019

Status Verified

May 1, 2019

Enrollment Period

1.1 years

First QC Date

May 3, 2019

Last Update Submit

May 3, 2019

Conditions

Outcome Measures

Primary Outcomes (1)

  • stone free rate

    complete disintegration of renal stones or having clinically insignificant gravel smaller than 2 mm

    2 weeks

Study Arms (3)

first group

patient who exposed to frequency 60 shock wave per min

Radiation: ESWL

second group

patient who exposed to frequency 80 shock wave per min

Radiation: ESWL

third group

patient who exposed to frequency 100 shock wave per min

Radiation: ESWL

Interventions

ESWLRADIATION

The impact of different frequencies on pattern of disintegration of renal stones

first groupsecond groupthird group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients were recruited from the outpatient clinic from age 18 years to 70 years old with renal stone who candidate for ESWL

You may qualify if:

  • Pelvic and upper ureteric stones
  • Stone size less than 2 cm
  • Stone density up to 1000 HU

You may not qualify if:

  • Lower calycle stone
  • Stone size 2 cm or more
  • Stone denstiy more than 1000
  • age group less than 18 y
  • uncontrolled hypertension patient and bleeding disorder
  • Pregnancy
  • Patients with UPJ obstruction, ureteral strictures,
  • Congenital anomalies
  • Previous stented ureter
  • Narrow neck of the calycx less than 30 %

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • Shinde S, Al Balushi Y, Hossny M, Jose S, Al Busaidy S. Factors Affecting the Outcome of Extracorporeal Shockwave Lithotripsy in Urinary Stone Treatment. Oman Med J. 2018 May;33(3):209-217. doi: 10.5001/omj.2018.39.

    PMID: 29896328BACKGROUND
  • McClinton S, Cameron S, Starr K, Thomas R, MacLennan G, McDonald A, Lam T, N'Dow J, Kilonzo M, Pickard R, Anson K, Keeley F, Burgess N, Clark CT, MacLennan S, Norrie J; TISU Study Group. TISU: Extracorporeal shockwave lithotripsy, as first treatment option, compared with direct progression to ureteroscopic treatment, for ureteric stones: study protocol for a randomised controlled trial. Trials. 2018 May 22;19(1):286. doi: 10.1186/s13063-018-2652-1.

    PMID: 29788982BACKGROUND

MeSH Terms

Conditions

Nephrolithiasis

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesUrolithiasisMale Urogenital Diseases

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
2 Weeks
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
M.B.B.CH

Study Record Dates

First Submitted

May 3, 2019

First Posted

May 6, 2019

Study Start

May 5, 2019

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

May 6, 2019

Record last verified: 2019-05