Ignite Creation Date:
2024-07-17 @ 10:46 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06469125
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-06-27
First Post:
2024-06-04
Brief Title:
Anatomic Endoscopic Prostate Enucleation and BICEP Classification
Sponsor:
Necmettin Erbakan University
Organization:
Necmettin Erbakan University
Study Overview
Official Title:
Multicentric Prospective Evaluation of Bladder Injuries During Morcellation Using BICEP Bladder Injury Classification During Endoscopic Procedures
Status:
ENROLLING_BY_INVITATION
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:
BICEP
Brief Summary:
The Bladder Injury Classification System for Endoscopic Procedure BICEP is designed to provide a systematic framework for categorizing bladder injuries that occur during endoscopic procedures By standardizing the classification of these injuries BICEP promotes a more consistent approach to diagnosis management and prevention across different urologic interventions This study aims to validate and implement the BICEP system during morcellation
This study will
Validate BICEP by using real-life clinical scenarios to ensure its applicability and effectiveness
Assess the incidence and types of bladder injuries during morcellation using the BICEP categorization to standardize injury reporting and enhance treatment protocols
This study will
Validate BICEP by using real-life clinical scenarios to ensure its applicability and effectiveness
Assess the incidence and types of bladder injuries during morcellation using the BICEP categorization to standardize injury reporting and enhance treatment protocols
Detailed Description:
Insufficient knowledge exists about bladder injuries during morcellation as the existing literature primarily consists of isolated case reports The Bladder Injury Classification System for Endoscopic Procedures BICEP aims to standardize the reporting and management of bladder injuries during endoscopic surgeries
This study proposes an external validation of the BICEP system through an international multicenter prospective observational study The objectives of this study are fourfold
Validate the newly developed BICEP classification system with real-life clinical scenarios to ensure its applicability and effectiveness
Evaluate the incidence and types of bladder injuries during morcellation using the BICEP framework to standardize injury reporting and enhance treatment protocols
Assess the robustness of BICEP across different departments Facilitate the adoption of BICEP as a global standard for classifying bladder injuries in endoscopic surgery
Through this study the validity of BICEP will be confirmed and the bladder injuries occurring during morcellation after AEEP will be examined
This study proposes an external validation of the BICEP system through an international multicenter prospective observational study The objectives of this study are fourfold
Validate the newly developed BICEP classification system with real-life clinical scenarios to ensure its applicability and effectiveness
Evaluate the incidence and types of bladder injuries during morcellation using the BICEP framework to standardize injury reporting and enhance treatment protocols
Assess the robustness of BICEP across different departments Facilitate the adoption of BICEP as a global standard for classifying bladder injuries in endoscopic surgery
Through this study the validity of BICEP will be confirmed and the bladder injuries occurring during morcellation after AEEP will be examined
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