NCT04763837|WithdrawnFDA Device
Study Stopped
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Sponsor study identifier
interventional
0
0 countries
N/A
Study Start
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
The purpose of this study is to determine if stents placed with only one loop in the kidney move more than stents placed with a loop in both the kidney and a bladder. Participants in this study will undergo placement of a stent into the ureter that drains urine from the kidney into the bladder. The stent will be placed in 1 of 2 ways: either with only a loop of the stent is left in the kidney or in the regular manner where a loop of the stent is left in both the kidney and in the bladder. The position of the stent will be measured at the time of placement. When the stent is removed, the position of the stent will be measured prior to pulling the stent.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 28, 2021
Actual (reported)February 21, 2021
Actual (reported)February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Stent migration
The distance that the stent migrates into the bladder or into the kidney.
12 months
Patient comfort level
12 months
Patients assigned to this group will undergo placement of an intraureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in only in the kidney and NOT in the bladder. This group will be the experimental group.
Patients assigned to this group will undergo placement of a double-J ureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in both the kidney and the bladder. This group will serve as the control.
This intervention involves the placement of an intraureteral stent, a tube that drains urine from the kidney to the bladder and has a loop of tube only in the kidney and NOT in the bladder. The distal end of the tube will stay in the ureter just proximal to the opening to the bladder.
Finney RP. Experience with new double J ureteral catheter stent. 1978. J Urol. 2002 Feb;167(2 Pt 2):1135-8; discussion 1139. doi: 10.1016/s0022-5347(02)80361-5. No abstract available.
Joshi HB, Okeke A, Newns N, Keeley FX Jr, Timoney AG. Characterization of urinary symptoms in patients with ureteral stents. Urology. 2002 Apr;59(4):511-6. doi: 10.1016/s0090-4295(01)01644-2.
Pollard SG, Macfarlane R. Symptoms arising from Double-J ureteral stents. J Urol. 1988 Jan;139(1):37-8. doi: 10.1016/s0022-5347(17)42282-8.
Kellen B Choi, DO, FACOS
Associate Professor, University of Louisville Department of Urology
0 participants (actual enrollment reported by the registry).
First Submitted
January 28, 2021
First Posted
This intervention involves the placement of a conventional double-J stent, a tube that drains urine from the kidney to the bladder and has a loop of tube in both the kidney and in the bladder.
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Yoshida T, Inoue T, Taguchi M, Matsuzaki T, Murota T, Kinoshita H, Matsuda T. Efficacy and Safety of Complete Intraureteral Stent Placement versus Conventional Stent Placement in Relieving Ureteral Stent Related Symptoms: A Randomized, Prospective, Single Blind, Multicenter Clinical Trial. J Urol. 2019 Jul;202(1):164-170. doi: 10.1097/JU.0000000000000196. Epub 2019 Jun 7.
Joshi HB, Newns N, Stainthorpe A, MacDonagh RP, Keeley FX Jr, Timoney AG. Ureteral stent symptom questionnaire: development and validation of a multidimensional quality of life measure. J Urol. 2003 Mar;169(3):1060-4. doi: 10.1097/01.ju.0000049198.53424.1d.
February 21, 2021
Study Start
February 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
April 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
April 29, 2022
Record last verified: 2022-04
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Source: ClinicalTrials.gov.
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