Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:50 AM
Study NCT ID:
NCT07438132
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Validation of the Identification System of Fiber-optic Probe Optical Coherent Tomography Assisted Pneumoperitoneum Creation
Sponsor:
Taipei Veterans General Hospital, Taiwan
Organization:
Study Overview
Official Title:
The Validation of the Identification System of Fiber-optic Probe Optical Coherent Tomography Assisted Pneumoperitoneum Creation
Status:
COMPLETED
Status Verified Date:
2025-10
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:
This observational study aims to evaluate the feasibility and safety of a newly developed "image-guided minimally invasive puncture needle" that integrates optical coherence tomography (OCT) technology during laparoscopic surgery. The device helps identify abdominal wall layers in real time and ensures safe creation of pneumoperitoneum. During laparoscopic procedures, the OCT-integrated needle will be used under direct visualization to collect abdominal wall tissue signal data and to analyze the image characteristics of different tissue layers.
Detailed Description:
This is an observational, prospective, single-center study conducted at Taipei Veterans General Hospital to evaluate the feasibility and safety of an "image-guided minimally invasive puncture needle" that integrates optical coherence tomography (OCT) technology for use during laparoscopic surgery.
The study device combines a Veress needle (ENDOPATH® Pneumoneedle Insufflation Needle, 14-gauge, 120 mm) with a swept-source OCT probe (central wavelength 1310 nm, bandwidth 100 nm, 100 kHz scanning rate). The OCT probe is inserted into the Veress needle, allowing side-view scanning at approximately 180° to visualize abdominal wall layers in real time during needle insertion. This design enables the detection of tissue-layer structures and helps ensure safe creation of pneumoperitoneum.
During standard laparoscopic procedures, pneumoperitoneum is first established in the conventional manner and confirmed under direct laparoscopic visualization. The image-guided puncture needle is then used under direct vision to puncture the abdominal wall at a designated site, while simultaneously collecting OCT signal data from the tissue layers. The acquired OCT signals are analyzed to characterize differences between tissue layers among patients and to validate the performance of the image-guided puncture system.
The primary objective is to acquire and analyze human abdominal wall OCT signals obtained with the image-guided minimally invasive puncture needle. The secondary objective is to evaluate the safety of the device during clinical use.
No additional procedures beyond standard laparoscopic surgery are introduced. All puncture procedures are performed under direct visualization, and safety is monitored intraoperatively. The collected OCT data will contribute to the development of an automated tissue recognition system and to the improvement of safety in laparoscopic entry techniques.
The study device combines a Veress needle (ENDOPATH® Pneumoneedle Insufflation Needle, 14-gauge, 120 mm) with a swept-source OCT probe (central wavelength 1310 nm, bandwidth 100 nm, 100 kHz scanning rate). The OCT probe is inserted into the Veress needle, allowing side-view scanning at approximately 180° to visualize abdominal wall layers in real time during needle insertion. This design enables the detection of tissue-layer structures and helps ensure safe creation of pneumoperitoneum.
During standard laparoscopic procedures, pneumoperitoneum is first established in the conventional manner and confirmed under direct laparoscopic visualization. The image-guided puncture needle is then used under direct vision to puncture the abdominal wall at a designated site, while simultaneously collecting OCT signal data from the tissue layers. The acquired OCT signals are analyzed to characterize differences between tissue layers among patients and to validate the performance of the image-guided puncture system.
The primary objective is to acquire and analyze human abdominal wall OCT signals obtained with the image-guided minimally invasive puncture needle. The secondary objective is to evaluate the safety of the device during clinical use.
No additional procedures beyond standard laparoscopic surgery are introduced. All puncture procedures are performed under direct visualization, and safety is monitored intraoperatively. The collected OCT data will contribute to the development of an automated tissue recognition system and to the improvement of safety in laparoscopic entry techniques.
Study Oversight
Has Oversight DMC:
True
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?: