Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 1:50 AM
Study NCT ID:
NCT07438132
Status:
COMPLETED
Last Update Posted:
2026-02-27
First Post:
2026-02-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Validation of the Identification System of Fiber-optic Probe Optical Coherent Tomography Assisted Pneumoperitoneum Creation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011027', 'term': 'Pneumoperitoneum'}], 'ancestors': [{'id': 'D010532', 'term': 'Peritoneal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D041623', 'term': 'Tomography, Optical Coherence'}], 'ancestors': [{'id': 'D041622', 'term': 'Tomography, Optical'}, {'id': 'D061848', 'term': 'Optical Imaging'}, {'id': 'D003952', 'term': 'Diagnostic Imaging'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D014054', 'term': 'Tomography'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-06', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-10', 'completionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-22', 'studyFirstSubmitDate': '2026-02-22', 'studyFirstSubmitQcDate': '2026-02-22', 'lastUpdatePostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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)', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laparoscopy', 'Optic coherence tomography'], 'conditions': ['Pneumoperitoneum', 'Laparoscopic Surgery']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThe 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.\n\nDuring 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.\n\nThe 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.\n\nNo 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undergoing laparoscopic surgery at Taipei Veterans General Hospital who meet the eligibility criteria and provide informed consent for participation in the observational study.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 20 to 90 years, male or female\n* Scheduled to undergo laparoscopic surgery\n* Able to provide informed consent\n\nExclusion Criteria:\n\n* History of two or more previous open or laparoscopic abdominal surgeries\n* Coagulation disorders that make surgery unsafe\n* Presence of massive ascites\n* Peritonitis or abdominal wall infection\n* Any condition judged by the investigator to make the patient unsuitable for laparoscopic surgery'}, 'identificationModule': {'nctId': 'NCT07438132', 'briefTitle': 'The Validation of the Identification System of Fiber-optic Probe Optical Coherent Tomography Assisted Pneumoperitoneum Creation', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Taipei Veterans General Hospital, Taiwan'}, 'officialTitle': 'The Validation of the Identification System of Fiber-optic Probe Optical Coherent Tomography Assisted Pneumoperitoneum Creation', 'orgStudyIdInfo': {'id': '2022-06-002A'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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.', 'interventionNames': ['Device: Image-Guided Minimally Invasive Puncture Needle Integrated with Optical Coherence Tomography (OCT)']}], 'interventions': [{'name': 'Image-Guided Minimally Invasive Puncture Needle Integrated with Optical Coherence Tomography (OCT)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Laparoscopic Surgery Patients']}]}, 'contactsLocationsModule': {'locations': [{'zip': '112201', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Taipei Veterans General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taipei Veterans General Hospital, Taiwan', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'National Science and Technology Council, Taiwan', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Chief, Department of Urology', 'investigatorFullName': 'Yi-Hsiu Huang', 'investigatorAffiliation': 'Taipei Veterans General Hospital, Taiwan'}}}}