Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547632
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-07
Brief Title:
ClearPetra Vacuum-assisted Ureteral Access Sheath vs Traditional Approach
Sponsor:
None
Organization:
None
Study Overview
Official Title:
ClearPetra Vacuum-assisted Ureteral Access Sheath vs Traditional Approach in Retrograde Intrarenal Surgery A 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:
VA-UAS vs trad
Brief Summary:
Ureteroscopy has been considered the best approach when treating renal stones smaller than 2 cm This procedure is usually performed together with ureteral access sheaths which helps protect the ureter mucosa and lowers intrarenal pressure
Recently a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration
Because there is little information on comparing this device with traditional approach no sheath or non-vacuum-assisted sheath in American population we aim to compare those devices in terms of their ability to clear the kidney from kidney stones as well as reduce infection rates postoperatively
Recently a new vacuum-assisted ureteral access sheath called ClearPetra has entered US market and allows for continuous stone fragmentation and aspiration
Because there is little information on comparing this device with traditional approach no sheath or non-vacuum-assisted sheath in American population we aim to compare those devices in terms of their ability to clear the kidney from kidney stones as well as reduce infection rates postoperatively
Detailed Description:
Retrograde intrarenal surgery RIRS is now considered gold-standard for treatment of renal stones smaller than 2 cm This procedure often employs a ureteral access sheath UAS as it helps to reduce intrarenal pressure and protects the ureter mucosa when basketing is required However the challenge imposed by residual stone fragments and sepsis remains Additionally natural elimination of residual stone fragments may induce renal colic hematuria an even the potential for new stone development Recently a new vacuum-assisted ureteral access sheath VA-UAS named ClearPetra provides concomitant stone fragmentation and aspiration
The new ClearPetra vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones It is a disposable access sheath equipped with a continuous flow aspiration mechanism Previous studies have demonstrated the safety and effectiveness of ClearPetra in RIRS Comprehensive comparative investigations between ClearPetra and traditional UAS in RIRS are lacking in American population We aim to compare the outcomes of using VA-UAS ClearPetra or traditional approach no sheath or non-vacuum-assisted sheath to treat patients with stone burden between 10 - 25 cm
The new ClearPetra vacuum assisted ureteral access sheath allows simultaneous fragmentation and extraction of stones It is a disposable access sheath equipped with a continuous flow aspiration mechanism Previous studies have demonstrated the safety and effectiveness of ClearPetra in RIRS Comprehensive comparative investigations between ClearPetra and traditional UAS in RIRS are lacking in American population We aim to compare the outcomes of using VA-UAS ClearPetra or traditional approach no sheath or non-vacuum-assisted sheath to treat patients with stone burden between 10 - 25 cm
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