Ignite Creation Date:
2024-10-25 @ 8:01 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06628765
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-09-28
Brief Title:
Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Two Types of Single-use Flexible Ureteroscopies for the Treatment of Upper Urinary Tract Stones in Children A Single-center Randomized Controlled Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The single-use digital flexible Ureteroscopy fURS is commonly used for the treatment of upper urinary tract stones The size of the outer diameter of the fURS can affect the safety efficacy and medical costs of the treatment Particularly for children their ureters are thinner and more tortuous compared to adults which places higher demands on medical devices The investigators are interested in determining if the performance of the two different sizes of fURS 63 Fr vs 86 Fr are equivalent This study will have guiding significance for the selection of upper urinary tract stones surgery in children in the future
Detailed Description:
The single-use digital fURS is a sterile disposable flexible endoscope Compared to traditional reusable digital flexible endoscopes single-use digital fURS has lower maintenance costs is easier to operate and effectively avoids cross-infection between patients With technological advancements the size of single-use digital fURS has become increasingly slim making them particularly suitable for children with narrow and tortuous ureters who suffered urinary stones Currently the single-use digital fURS used in our unit has an outer diameter of 86Fr For younger children the success rate of the first insertion of the fURS is still relatively low When the fURS cannot pass through the ureter it is necessary to actively dilate the ureter with a balloon in one stage or passively dilate it with a urethral stent during the procedure to facilitate a second-stage fURS procedure This not only increases the risk of ureteral injury but also incurs additional medical expenses Recently HugeMed Company has launched a single-use digital fURS with an outer diameter of 63 Fr which is currently the thinnest single-use fURS in the world and its effectiveness and safety have been preliminarily verified in clinical practice The purpose of this study is to compare the safety and efficacy of the 63 Fr fURS HU30S and the 86 Fr fURS XFGC-FU-660RC in the clinical treatment of upper urinary tract stones in children
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None