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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT00918528
Other study ID # 0020-09-HYMC
Secondary ID
Status Not yet recruiting
Phase Phase 1/Phase 2
First received June 9, 2009
Last updated June 10, 2009
Start date June 2009

Study information

Verified date June 2009
Source Hillel Yaffe Medical Center
Contact n/a
Is FDA regulated No
Health authority Israel: Ministry of Health
Study type Interventional

Clinical Trial Summary

The aim of this study is to evaluate the efficacy of local injected mitomycin C at the time of internal urethrotomy in order to prevent the recurrence of urethral strictures.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Male
Age group 18 Years to 85 Years
Eligibility Inclusion Criteria:

- Male urethral stricture suitable for internal urethrotomy

- Stricture length less than 10 mm

Exclusion Criteria:

- Stricture length over 10 mm

- Benign prostate enlargement

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Procedure:
Internal urethrotomy

Drug:
Mitomycin C - local injection


Locations

Country Name City State
Israel Hillel Yaffe Medical Center Hadera

Sponsors (1)

Lead Sponsor Collaborator
Hillel Yaffe Medical Center

Country where clinical trial is conducted

Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Urethral stricture recurrence One year No
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