A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture (NCT04021901) | Clinical Trial Compass
UnknownNot Applicable
A Study of Balloon Dilatation for the Treatment of Benign Ureteral Stricture
China420 participantsStarted 2018-11-01
Plain-language 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 balloon dilation, and provide further guidance for endoscopic treatment of benign ureteral stricture.
Who can participate
Age range18 Years – 70 Years
SexALL
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Inclusion Criteria:
* • 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 Criteria:
* • 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 unab…
What they're measuring
1
Rate of treatment success in follow-up results after 6 months