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

Taipei Veterans General Hospital

Status: Completed

Conditions: Laparoscopic Surgery; Pneumoperitoneum

Treatments: Device: Image-Guided Minimally Invasive Puncture Needle Integrated with Optical Coherence Tomography (OCT)

Study type: Observational

Funder types: Other

Identifiers

NCT07438132

2022-06-002A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

12 participants in 1 patient group

Laparoscopic Surgery Patients

Description:

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.

Treatment:

Device: Image-Guided Minimally Invasive Puncture Needle Integrated with Optical Coherence Tomography (OCT)