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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01117701
Other study ID # 102.09 (REK) - 4
Secondary ID 21835 (NSD) - 41
Status Completed
Phase N/A
First received May 4, 2010
Last updated March 17, 2015
Start date May 2010
Est. completion date December 2012

Study information

Verified date June 2011
Source Helse-Bergen HF
Contact n/a
Is FDA regulated No
Health authority Norway:National Committee for Medical and Health Research EthicsNorway: Norwegian Social Science Data Services
Study type Interventional

Clinical Trial Summary

The purpose of this study is to investigate to forces needed to passage the ureteroscope up and down the ureter with and without a safety guidewire in place.


Description:

Ureteroscopy may damage the ureter, and the complication risk is influenced by the forces needed to move the ureteroscope up and down the ureter.

Although a safety guidewire (SGW) is commonly recommended in order to reduce the complication rate it may well be that the SGW itself may inhibit the passage of the ureteroscope due to increased friction.

The forces needed to move the ureteroscope in the ureter have not been investigated properly.

The intention in this study is to measure the forces needed to advance and withdraw the ureteroscope in the ureter with and without the SGW in place.


Recruitment information / eligibility

Status Completed
Enrollment 40
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Patients planned for endoscopic kidney stone treatment

Exclusion Criteria:

- Known pathology in the ureter

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label


Related Conditions & MeSH terms


Intervention

Procedure:
Ureteroscopy with and without safety guidewire
In study arm A - with SGW, the force measurements are made with a safety guidewire in place. In study arm B - without SGW, the force measurements are made without SGW.

Locations

Country Name City State
Norway Helse Bergen HF, Haukeland University Hospital Bergen

Sponsors (1)

Lead Sponsor Collaborator
Helse-Bergen HF

Country where clinical trial is conducted

Norway, 

Outcome

Type Measure Description Time frame Safety issue
Primary The force needed to passage the ureteroscope up and down in the ureter with and without SGW. The force is measured by a digital force-meter device. The force measured is scaled in Newton. The results are available immediately after each measurement. 1 day Yes
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