NCT02469766

Brief Summary

This study will be conducted to compare the success and complication rates of ureteroscopy, and shockwaves lithotripsy for treatment of upper ureteric stones ≤1 cm.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
240

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Mar 2015

Geographic Reach
1 country

1 active site

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

Study Start

First participant enrolled

March 1, 2015

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 9, 2015

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 11, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2016

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
Last Updated

August 30, 2016

Status Verified

August 1, 2016

Enrollment Period

1.4 years

First QC Date

June 9, 2015

Last Update Submit

August 28, 2016

Conditions

Ureteric Stones

Keywords

ureteral stonesureterureteroscopyflexibleSWL

Outcome Measures

Primary Outcomes (1)

  • Stone free rate

    The stone free rate will be evaluated with non-contrast CT

    3 months

Secondary Outcomes (1)

  • Complication rate

    2 weeks

Study Arms (3)

Extracorporeal Shockwaves

ACTIVE COMPARATOR

Patients in this arm will undergo SWL

Procedure: SWL

Semirigid URS

ACTIVE COMPARATOR

Patients in this arm will undergo Semirigid Ureteroscopy

Procedure: Semirigid URS

Flexible URS

ACTIVE COMPARATOR

Patients in this arm will undergo Flexible Ureteroscopy

Procedure: Flexible URS

Interventions

SWLPROCEDURE

Patients in this arm will undergo SWL

Extracorporeal Shockwaves
Semirigid URSPROCEDURE

Patients in this arm will undergo semirigid URS

Semirigid URS
Flexible URSPROCEDURE

Patients in this arm will undergo Flexible URS

Flexible URS

Eligibility Criteria

Age14 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Radio-opaque stones
  • less than or equal 1 cm

You may not qualify if:

  • Active UTI
  • Coagulopathy
  • Pregnancy
  • Ureteric stricture

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, Dakhlia, 35516, Egypt

RECRUITING

Study Officials

  • Ahmed M Shoma, MD

    Mansoura University

    STUDY CHAIR

Central Study Contacts

Muhamad M abdallateef, MD

CONTACT

01009681644seif_1901@yahoo.com

Ahmed R EL-Nahas, MD

CONTACT

+20502202222ar_el_nahas@yahoo.com

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

June 9, 2015

First Posted

June 11, 2015

Study Start

March 1, 2015

Primary Completion

August 1, 2016

Study Completion

September 1, 2016

Last Updated

August 30, 2016

Record last verified: 2016-08

Locations

EG(1)