Ignite Creation Date:
2024-10-26 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 3:36 PM
Study NCT ID:
NCT06526754
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-07-19
Brief Title:
Feasibility Analysis of LCD-SLA 3D Printing Technology for Overall Surgical Planning of Liver Malignant Tumors
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Feasibility Analysis of LCD-SLA 3D Printing Technology for Overall Surgical Planning of Liver Malignant Tumors
Status:
COMPLETED
Status Verified Date:
2024-09
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:
This study aims to evaluate the effectiveness of 3D-printed liver models in hepatobiliary surgery planning compared to traditional digital simulations It is conducted in three phases
1 Development and validation of 35 3D-printed liver models focusing on timeliness cost precision and alignment with digital planning tools
2 Optimization of the 3D reconstruction process using deep learning to enhance model accuracy and efficiency
3 A retrospective comparative analysis of surgical outcomes in 64 patients with one group using 3D-printed models and the other using digital simulations for surgical planning
1 Development and validation of 35 3D-printed liver models focusing on timeliness cost precision and alignment with digital planning tools
2 Optimization of the 3D reconstruction process using deep learning to enhance model accuracy and efficiency
3 A retrospective comparative analysis of surgical outcomes in 64 patients with one group using 3D-printed models and the other using digital simulations for surgical planning
Detailed Description:
The study was conducted in three phases to assess the effectiveness of 3D-printed liver models for hepatobiliary surgery planning comparing these models with traditional digital simulations
Phase One This phase involved the development and validation of 35 3D-printed liver models The focus was on timeliness cost precision and alignment with digital planning tools The goal was to ensure that the physical models accurately represented the livers anatomy as planned digitally
Phase Two In this phase the 3D reconstruction process was optimized using deep learning techniques The study compared AI-assisted automatic segmentation with manual methods to enhance the accuracy and efficiency of the models This phase aimed to streamline the model creation process and reduce the time and effort required
Phase Three This phase conducted a retrospective comparative analysis involving 64 patients who underwent hepatobiliary surgery These patients were divided into two groups one group used validated physical 3D models and the other group used digital simulations for surgical planning The phase evaluated various surgical outcomes including the extent of resection operation time intraoperative blood loss and hospitalization duration The primary objective was to determine the clinical effectiveness of using 3D-printed models compared to traditional digital simulations in hepatobiliary surgery planning
By systematically analyzing these three phases the study aims to provide comprehensive insights into the benefits and potential limitations of using 3D-printed models in surgical planning ultimately enhancing patient outcomes and surgical precision
Phase One This phase involved the development and validation of 35 3D-printed liver models The focus was on timeliness cost precision and alignment with digital planning tools The goal was to ensure that the physical models accurately represented the livers anatomy as planned digitally
Phase Two In this phase the 3D reconstruction process was optimized using deep learning techniques The study compared AI-assisted automatic segmentation with manual methods to enhance the accuracy and efficiency of the models This phase aimed to streamline the model creation process and reduce the time and effort required
Phase Three This phase conducted a retrospective comparative analysis involving 64 patients who underwent hepatobiliary surgery These patients were divided into two groups one group used validated physical 3D models and the other group used digital simulations for surgical planning The phase evaluated various surgical outcomes including the extent of resection operation time intraoperative blood loss and hospitalization duration The primary objective was to determine the clinical effectiveness of using 3D-printed models compared to traditional digital simulations in hepatobiliary surgery planning
By systematically analyzing these three phases the study aims to provide comprehensive insights into the benefits and potential limitations of using 3D-printed models in surgical planning ultimately enhancing patient outcomes and surgical precision
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