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 range

20 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

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