Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2025-12-26 @ 3:59 AM
Study NCT ID:
NCT03217318
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2017-07-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Reduction of Stent Associated Morbidity by Minimizing Stent Material.
Sponsor:
Cantonal Hospital of St. Gallen
Organization:
Study Overview
Official Title:
Reduction of Stent Associated Morbidity by Minimizing Stent Material: A Prospective Randomized Single-blind Study Assessing a Novel "Suture-Stent".
Status:
COMPLETED
Status Verified Date:
2019-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
After providing informed consent, patients will be randomized into one of two groups (single-blinded): Group 1 will receive a standard Percuflex® (Boston scientific) ureteral stent. Diameter: 6F, length according to surgeons' estimation. Patients in Group 2 will receive a Suture-Stent adjusted to the individual stone location.
All participant receive standardized patient information, using a validated leaflet on ureteral stenting and associated morbidity.
In both groups, patients will complete the Ureteral Stent Symptoms Questionnaire (USSQ) 1 week after stent insertion, prior to stent removal (i.e. 2-6 weeks after insertion) and after (2-6 weeks) stent removal. USSQ results after stent removal serve as an assessment of "baseline symptoms". During secondary stone removal, stents are removed and ureteral dilatation / access is assessed.
The removed stents will be assessed for biofilm formation within the framework of an approved and ongoing study on the development of a Biofilm-model (EKSG 15/084). Potential complications and adverse events are assessed at all scheduled and unscheduled patient visits.
All participant receive standardized patient information, using a validated leaflet on ureteral stenting and associated morbidity.
In both groups, patients will complete the Ureteral Stent Symptoms Questionnaire (USSQ) 1 week after stent insertion, prior to stent removal (i.e. 2-6 weeks after insertion) and after (2-6 weeks) stent removal. USSQ results after stent removal serve as an assessment of "baseline symptoms". During secondary stone removal, stents are removed and ureteral dilatation / access is assessed.
The removed stents will be assessed for biofilm formation within the framework of an approved and ongoing study on the development of a Biofilm-model (EKSG 15/084). Potential complications and adverse events are assessed at all scheduled and unscheduled patient visits.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: