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

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.

Study Overview

• Status: Completed
• Conditions: Laparoscopic Surgery; Pneumoperitoneum
• Intervention / Treatment: Device: Image-Guided Minimally Invasive Puncture Needle Integrated with Optical Coherence Tomography (OCT)

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.

• Study Type: Observational
• Enrollment (Actual): 12

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 112201
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients undergoing laparoscopic surgery at Taipei Veterans General Hospital who meet the eligibility criteria and provide informed consent for participation in the observational study.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan
• Collaborators: National Science and Technology Council, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): September 6, 2023
• Primary Completion (Actual): December 4, 2024
• Study Completion (Actual): December 4, 2024

Study Registration Dates

• First Submitted: February 22, 2026
• First Submitted That Met QC Criteria: February 22, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 22, 2026
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Laparoscopy; Optic coherence tomography
• Additional Relevant MeSH Terms: Digestive System Diseases; Peritoneal Diseases; Pneumoperitoneum; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Diagnostic Imaging; Tomography, Optical; Optical Imaging; Tomography, Optical Coherence
• Other Study ID Numbers: 2022-06-002A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No