Ureteroscopy With and Without Safety Guidewire

Urolithiasis Clinical Trial

Official title:

Ureteroscopy With and Without Safety Guidewire:. A Prospective, Randomized Study of the Results of Endoscopic Treatment of Urolithiasis.

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01117688
• Other study ID #: 102.09 (REK) - 3
• Secondary ID: 21835 (NSD) - 31
• Status: Withdrawn
• Phase: N/A
• First received: May 4, 2010
• Last updated: March 31, 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 the impact of a safety guidewire (SGW) on the results of ureteroscopy for urolithiasis.

Study hypothesis: Routine use of SGW has no impact on the results of ureteroscopic treatment of urolithiasis.

Description:

The use of SGW is generally recommended at any ureteroscopic procedure in order to facilitate the introduction of the endoscope and to secure placement of internal tubes for drainage of urine after the procedure.

However, SGW may be an obstacle to efficient disintegration and retraction of calculi in the narrow ureter.

The intention of this study is to compare the results of endoscopic stone treatment with and without the use of SGW.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• 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 with urolithiasis planned for ureterorenoscopic treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Urolithiasis

Intervention

Procedure:
• Ureteroscopy with and without safety guidewire
In study arm A - with SGW, endoscopic treatment is performed with a safety guidewire in place. In study arm B - without SGW, the ureteroscopy is performed 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	Stone free-rate		3 months after treatment	No
Secondary	Hospital stay		Up to 1 week after the operation	No
Secondary	Complication rate		Until 3 months after the procedure	Yes
Secondary	Operating time		Up to 1 day after the surgery	No