Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction (TSTENT)
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ClinicalTrials.gov Identifier: NCT05992363 |
Recruitment Status :
Not yet recruiting
First Posted : August 15, 2023
Last Update Posted : August 15, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hydronephrosis; Obstruction, Ureter Renal Failure Malignancy Ureter Obstruction Ureter Stricture | Device: ureteral stent\s insertion | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 106 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Tandem Polyurethane Stents Compared to Single Silicone Stent for Malignant Ureteral Obstruction |
Estimated Study Start Date : | October 2023 |
Estimated Primary Completion Date : | December 2025 |
Estimated Study Completion Date : | December 2026 |
Arm | Intervention/treatment |
---|---|
Active Comparator: single silicone stent
patients with malignant ureteral obstruction that was treated by single large-caliber 8-12Fr silicone stent
|
Device: ureteral stent\s insertion
ureteral stent\s insertion in the operating room |
Active Comparator: Tandem polyurethane stents
patients with malignant ureteral obstruction that was treated by tandem 6 Fr Percuflex™ stents
|
Device: ureteral stent\s insertion
ureteral stent\s insertion in the operating room |
- stent failure rate [ Time Frame: 1 year ]Failure will be defined when two of the following three appear: renal colic, rise in serum creatinine, hydronephrosis
- quality of life [ Time Frame: 1 year ]using the Ureteral stent symptom questionnaire (USSQ) score
- overall survival [ Time Frame: 1 year ]overall survival
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- patient with malignant ureteral obstruction
Exclusion Criteria:
- ureteral obstruction of other causes
- Language comprehension or other limitation in giving informed consent
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05992363
Israel | |
Rabin Medical Center | |
Petah Tikva, Israel, 49414 | |
Sheba medical center | |
Ramat Gan, Israel | |
Contact: Ari Luder, MD +972527812580 ariluder@yahoo.com |
Responsible Party: | Michael Frumer, Urologist, Rabin Medical Center |
ClinicalTrials.gov Identifier: | NCT05992363 |
Other Study ID Numbers: |
0100-23-RMC |
First Posted: | August 15, 2023 Key Record Dates |
Last Update Posted: | August 15, 2023 |
Last Verified: | August 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Hydronephrosis Ureteral Obstruction Kidney Diseases Urologic Diseases Female Urogenital Diseases |
Female Urogenital Diseases and Pregnancy Complications Urogenital Diseases Male Urogenital Diseases Ureteral Diseases |