CompletedNot Applicable

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

Taiwan12 participantsStarted 2023-09-06

Plain-language 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.

Who can participate

Age range20 Years – 90 Years

SexALL

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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

What they're measuring

Successful Acquisition of Optical Coherence Tomography (OCT) Images of Abdominal Wall Tissue Layers During Laparoscopic Surgery Using the Image-Guided Minimally Invasive Puncture Needle

Timeframe: During laparoscopic surgery (intraoperative period)

Trial details

NCT IDNCT07438132

SponsorTaipei Veterans General Hospital, Taiwan

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-12-04

View on ClinicalTrials.gov More Pneumoperitoneum trials