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| Name | Class |
|---|---|
| National Science and Technology Council, Taiwan | OTHER_GOV |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Laparoscopic Surgery Patients | Patients undergoing laparoscopic surgery in whom an image-guided minimally invasive puncture needle integrated with optical coherence tomography (OCT) is used to collect abdominal wall tissue signal data under direct visualization. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Image-Guided Minimally Invasive Puncture Needle Integrated with Optical Coherence Tomography (OCT) | Device | The image-guided minimally invasive puncture needle integrated with optical coherence tomography (OCT) is a modified Veress needle combined with a swept-source OCT probe (central wavelength 1310 nm, bandwidth 100 nm, 100 kHz scanning rate). The probe is inserted into the Veress needle, allowing side-view scanning of approximately 180 degrees for real-time visualization of abdominal wall tissue layers. The device is used intraoperatively during laparoscopic surgery under direct visualization to collect optical signal data from the abdominal wall. |
| Measure | Description | Time Frame |
|---|---|---|
| Successful Acquisition of Optical Coherence Tomography (OCT) Images of Abdominal Wall Tissue Layers During Laparoscopic Surgery Using the Image-Guided Minimally Invasive Puncture Needle | Successful acquisition of real-time optical coherence tomography (OCT) images of abdominal wall tissue layers (fat, fascia, muscle, peritoneum) during laparoscopic surgery. OCT image quality was verified by correspondence between the displayed tissue layers and laparoscopic visualization at the time of needle insertion. | During laparoscopic surgery (intraoperative period) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients undergoing laparoscopic surgery at Taipei Veterans General Hospital who meet the eligibility criteria and provide informed consent for participation in the observational study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Veterans General Hospital | Taipei | 112201 | Taiwan |
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|
| ID | Term |
|---|---|
| D011027 | Pneumoperitoneum |
| ID | Term |
|---|---|
| D010532 | Peritoneal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| D041623 | Tomography, Optical Coherence |
| ID | Term |
|---|---|
| D041622 | Tomography, Optical |
| D061848 | Optical Imaging |
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014054 | Tomography |
| D008919 | Investigative Techniques |
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