NCT03559738

Brief Summary

comparative study of two treatment modalities (ureteroscopy and extracorporeal shock wave lithotripsy) in management of upper third ureteral calculi

Trial Health

100
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2016

Status
completed

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

June 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

June 6, 2018

Completed
12 days until next milestone

First Posted

Study publicly available on registry

June 18, 2018

Completed
Last Updated

June 18, 2018

Status Verified

June 1, 2018

Enrollment Period

2 years

First QC Date

June 6, 2018

Last Update Submit

June 6, 2018

Conditions

Ureteral Stones

Outcome Measures

Primary Outcomes (1)

  • identify best management for upper third ureter stones

    Matched Pair Analysis of Extracorporeal Shock Wave Lithotripsy versus Ureteroscopy for the management of Upper Ureteral Calculi with relatively small study group by comparing like-for-like Stones

    2 years

Study Arms (1)

Patients With Upper Ureteric Stones

Patients with upper ureteral stones more than 1cm and 1000 HU

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

A total of 60 cases will be assigned to either ESWL or URS randomly

You may qualify if:

  • \- The study will include patients in the age group of 18-70 years with body mass index of less than or equal to 30 kg/m2 with Upper Ureteral Calculi more than or equal to 1 cm with density about 900 - 1100 HU

You may not qualify if:

  • Patients with distal obstruction
  • Impacted stones : An impacted stone is defined as a stone where a guidewire will not pass without ancillary measures and/or a stone that does not move when forceful irrigation is applied ureteroscopically
  • Marked hydronephrosis : gross dilation/ballooning of the renal pelvis and calyces with loss of borders between the renal pelvis and calyces and renal atrophy seen as cortical thinning
  • Radiolucent stones
  • Pregnancy
  • Stones in Children
  • Spinal deformity
  • Morbid obesity
  • Patients on Aspirin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident

Study Record Dates

First Submitted

June 6, 2018

First Posted

June 18, 2018

Study Start

June 1, 2016

Primary Completion

June 1, 2018

Study Completion

June 1, 2018

Last Updated

June 18, 2018

Record last verified: 2018-06