The Validation of the Identification System of Fiber-optic Probe Optical Coherent Tomography Assisted Pneumoperitoneum Creation

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.

Inclusion criteria

• Adults aged 20 to 90 years, male or female
• Scheduled to undergo laparoscopic surgery
• Able to provide informed consent

Exclusion criteria

• History of two or more previous open or laparoscopic abdominal surgeries
• Coagulation disorders that make surgery unsafe
• Presence of massive ascites
• Peritonitis or abdominal wall infection
• Any condition judged by the investigator to make the patient unsuitable for laparoscopic surgery