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

NCT07438132 | Completed DMC

• 1 other identifier: 2022-06-002A
• Study Type: observational
• Target: 12
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumoperitoneum; Laparoscopic Surgery

Keywords

Laparoscopy; Optic coherence tomography

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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)

Interventions

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.

Laparoscopic Surgery Patients

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead
• National Science and Technology Council, Taiwan: collaborator

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

Location

MeSH Terms

Conditions

Pneumoperitoneum

Interventions

Tomography, Optical Coherence

Condition Hierarchy (Ancestors)

Peritoneal Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Tomography, Optical; Optical Imaging; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Tomography; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chief, Department of Urology

Study Record Dates

• First Submitted: February 22, 2026
• First Posted: February 27, 2026
• Study Start: September 6, 2023
• Primary Completion: December 4, 2024
• Study Completion: December 4, 2024
• Last Updated: February 27, 2026

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)