Status:
UNKNOWN
A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture
Lead Sponsor:
Changhai Hospital
Conditions:
Stricture Ureter
Eligibility:
All Genders
18-70 years
Brief Summary
This study is designed to treat benign ureteral stricture with balloon dilatation through prospective multicenter studies. It aims to indications, procedure standards, and therapeutic effects of ballo...
Detailed Description
Benign ureteral stricture refers to a urinary tract obstruction caused by a partial or full ureteral lumen that is less normal than normal. It can lead to urinary dilatation, water accumulation, and r...
Eligibility Criteria
Inclusion
- • Subject has provided informed consent and indicated a willingness to comply with study treatments
- Subject is 18-70 yrs of age
- Subject can be either male or female
- Subject diagnosed with ureteral stricture or atresia by enhanced CTU, intravenous pyelography or retrograde pyelography;
- Subject's ureteral stenosis length is ≤ 2cm (single or multiple segments)
Exclusion
- • Subject has any congenital ureteral anatomical deformity, abdominal organ compression, oppression caused by malignant tumor metastasis
- Subject has poor result after endoscopic balloon dilatation treatment
- Subject has a GFR \<25% on the affected side of the kidney
- Subject has an active urinary tract infection (e.g., cystitis, prostatitis, urethritis, etc.)
- Subject has been diagnosed with a urethral stricture or bladder neck contracture
- Subject has been diagnosed with a urinary tract infection related to stone obstruction within two weeks
- Subject has severe hematuria that might blur the vision of the endoscopy
- Subject is pregnant or in monthly period
- Subject has coexistent disease like systemic disease, heart disease, lung disfuction or other diseases that could not tolerate the endoscopic surgery or anesthesia.
- Subject has unadjusted diabetes or high blood pressure
- Subject has a disorder of the coagulation cascade system that would put the subject at risk for intraoperative or postoperative bleeding
- Subject is unable to discontinue anticoagulant and antiplatelet therapy preoperatively (2 weeks)
Key Trial Info
Start Date :
November 1 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2019
Estimated Enrollment :
420 Patients enrolled
Trial Details
Trial ID
NCT04021901
Start Date
November 1 2018
End Date
December 1 2019
Last Update
July 16 2019
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200433