Ignite Creation Date:
2024-07-17 @ 12:01 PM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469736
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-24
First Post:
2024-06-13
Brief Title:
Comparison Between Ureterorenoscopy With Lithotripsy Alone Versus Combination With Hydrogel for Kidney Stone Removal
Sponsor:
Technical University of Munich
Organization:
Technical University of Munich
Study Overview
Official Title:
Standard of Care Ureterorenoscopy With Lithotripsy Versus in Combination With the Hydrogel Method for Kidney Stone Removal An Open Randomized Monocentric Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
The incidence of kidney stones urolithiasis has surged in both developing and developed countries affecting approximately 15 of the global population From 2010 to 2019 diagnoses of kidney and ureteral stones rose by 8 in Germany 26 in France and 15 in England Correspondingly the number of surgical stone removal procedures increased by 3 38 and 18 respectively Common treatments include extracorporeal shock wave lithotripsy ESWL ureterorenoscopy URS with lithotripsy and percutaneous nephrolithotomy PCNL
URS depending on stone size has become a preferred method due to advancements in intraoperative imaging and laser technology Despite these improvements small fragments often remain post-intervention leading to recurrent stones Complete removal of all fragments is crucial to significantly reduce recurrence rates Current literature suggests a high recurrence rate with residual fragments impacting healthcare costs and patient quality of life
A key objective in endourological research is optimizing the stone clearance rate Techniques like coagulum lithotomy and the autologous blood clot technique have been developed to enhance residual stone removal after laser fragmentation These methods benefit selected patients but are not widely adopted due to complications such as reduced intraoperative visibility and long coagulum formation times
Recently a two-component hydrogel system called mediNiK Purenum GmbH Germany was developed This biocompatible gel can be applied through an endoscope after stone fragmentation and large fragment retrieval to embed smaller fragments and dust forming a removable conglomerate MediNiK has demonstrated effectiveness in embedding and removing stone residues and is already in clinical use in Europe showing potential for optimizing stone removal
A multicenter study has assessed the safety and tolerability of mediNiK in standard URS Open randomized multicentre study to evaluate the safety tolerability and performance of mediNiK compared to standard treatment in kidney stone removal - DRKS00030532 Results indicate the gel is safe and tolerable However further data from larger cohorts and comparisons with conventional URS are necessary before widespread adoption of mediNiK
URS depending on stone size has become a preferred method due to advancements in intraoperative imaging and laser technology Despite these improvements small fragments often remain post-intervention leading to recurrent stones Complete removal of all fragments is crucial to significantly reduce recurrence rates Current literature suggests a high recurrence rate with residual fragments impacting healthcare costs and patient quality of life
A key objective in endourological research is optimizing the stone clearance rate Techniques like coagulum lithotomy and the autologous blood clot technique have been developed to enhance residual stone removal after laser fragmentation These methods benefit selected patients but are not widely adopted due to complications such as reduced intraoperative visibility and long coagulum formation times
Recently a two-component hydrogel system called mediNiK Purenum GmbH Germany was developed This biocompatible gel can be applied through an endoscope after stone fragmentation and large fragment retrieval to embed smaller fragments and dust forming a removable conglomerate MediNiK has demonstrated effectiveness in embedding and removing stone residues and is already in clinical use in Europe showing potential for optimizing stone removal
A multicenter study has assessed the safety and tolerability of mediNiK in standard URS Open randomized multicentre study to evaluate the safety tolerability and performance of mediNiK compared to standard treatment in kidney stone removal - DRKS00030532 Results indicate the gel is safe and tolerable However further data from larger cohorts and comparisons with conventional URS are necessary before widespread adoption of mediNiK
Detailed Description:
The incidence of kidney stones urolithiasis has increased in both developing and developed countries affecting around 15 of the worlds population 1 Between 2010 and 2019 the diagnosis of kidney and ureteral stones in Germany France and England increased by 8 26 and 15 respectively while the number of surgical procedures to remove stones increased by 3 38 and 18 respectively 2 Common surgical treatments for kidney stones include extracorporeal shock wave lithotripsy ESWL ureterorenoscopy URS with lithotripsy and percutaneous nephrolithotomy PCNL
Depending on the size of the stone URS has sometimes established itself as the method of choice not least thanks to improved intraoperative imaging and the further development of laser technology Despite these innovations small fragments can remain in the kidney post-intervention which in turn can lead to new stone formation recurrent stones From a medical point of view complete removal of all fragments is essential in order to significantly reduce the recurrence rate of affected patients According to the current literature the recurrence rate in the sense of so-called secondary stone formation is estimated to be high in the case of residual fragments 3 associated with associated costs for the healthcare system and restrictions in the quality of life of the affected patients
A major goal of endourological research in this area is therefore to optimize the stone clearance rate Procedures such as coagulum lithotomy or the autologous blood coagel technique have been developed to improve the removal of residual stones after laser-guided fragmentation Selected patients can benefit from these techniques but their widespread use is limited particularly due to the often associated deterioration in intraoperative visibility and the long waiting times until coagulum formation 4 For this reason a two-component hydrogel system called mediNiK Purenum GmbH Germany was recently developed This gel consisting of two biocompatible components can be applied via the inserted endoscope in a controlled manner and under visualization after completion of stone fragmentation and retrieval of large fragments in order to embed smaller stone fragments and dust The resulting conglomerate can then be removed using conventional grasping forceps 5
The hydrogel method with mediNik has proven to be effective in embedding and removing stone residues 6 The system is already being used clinically in Europe and shows great potential for optimizing stone removal A safety assessment in a multicenter study has already shown that the use of the gel is safe and tolerable in the context of standard URS Open randomized multicentre study to evaluate the safety tolerability and performance of mediNiK compared to standard treatment in the removal of kidney stones - DRKS00030532 - httpsdrksdesearchdetrialDRKS00030532 However before mediNik can be used across the board further data in a larger cohort and in particular a comparison with conventional URS are required
The primary objective of this study is to compare the standard URS for the treatment of kidney stones without and with mediNik with regard to the postoperative stone clearance rate Further secondary endpoints are described in chapter 4 The results should provide the central basis for optimizing stone therapy at European centers and thereby improving medical care while optimizing costs
Depending on the size of the stone URS has sometimes established itself as the method of choice not least thanks to improved intraoperative imaging and the further development of laser technology Despite these innovations small fragments can remain in the kidney post-intervention which in turn can lead to new stone formation recurrent stones From a medical point of view complete removal of all fragments is essential in order to significantly reduce the recurrence rate of affected patients According to the current literature the recurrence rate in the sense of so-called secondary stone formation is estimated to be high in the case of residual fragments 3 associated with associated costs for the healthcare system and restrictions in the quality of life of the affected patients
A major goal of endourological research in this area is therefore to optimize the stone clearance rate Procedures such as coagulum lithotomy or the autologous blood coagel technique have been developed to improve the removal of residual stones after laser-guided fragmentation Selected patients can benefit from these techniques but their widespread use is limited particularly due to the often associated deterioration in intraoperative visibility and the long waiting times until coagulum formation 4 For this reason a two-component hydrogel system called mediNiK Purenum GmbH Germany was recently developed This gel consisting of two biocompatible components can be applied via the inserted endoscope in a controlled manner and under visualization after completion of stone fragmentation and retrieval of large fragments in order to embed smaller stone fragments and dust The resulting conglomerate can then be removed using conventional grasping forceps 5
The hydrogel method with mediNik has proven to be effective in embedding and removing stone residues 6 The system is already being used clinically in Europe and shows great potential for optimizing stone removal A safety assessment in a multicenter study has already shown that the use of the gel is safe and tolerable in the context of standard URS Open randomized multicentre study to evaluate the safety tolerability and performance of mediNiK compared to standard treatment in the removal of kidney stones - DRKS00030532 - httpsdrksdesearchdetrialDRKS00030532 However before mediNik can be used across the board further data in a larger cohort and in particular a comparison with conventional URS are required
The primary objective of this study is to compare the standard URS for the treatment of kidney stones without and with mediNik with regard to the postoperative stone clearance rate Further secondary endpoints are described in chapter 4 The results should provide the central basis for optimizing stone therapy at European centers and thereby improving medical care while optimizing costs
Study Oversight
Has Oversight DMC:
None
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?:
None