Ignite Creation Date:
2025-12-25 @ 5:02 AM
Ignite Modification Date:
2025-12-26 @ 4:03 AM
Study NCT ID:
NCT05557318
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2022-09-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014627', 'term': 'Vaginitis'}], 'ancestors': [{'id': 'D014623', 'term': 'Vaginal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D020133', 'term': 'Reverse Transcriptase Polymerase Chain Reaction'}, {'id': 'D046508', 'term': 'Culture Techniques'}], 'ancestors': [{'id': 'D016133', 'term': 'Polymerase Chain Reaction'}, {'id': 'D021141', 'term': 'Nucleic Acid Amplification Techniques'}, {'id': 'D005821', 'term': 'Genetic Techniques'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D066298', 'term': 'In Vitro Techniques'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This clinical study is a prospective study to evaluate the sensitivity and specificity of the Ainos Flora Female Vaginal Health Tester in identifying vaginal infections. Potential subjects will be patients in the gynecological clinic. The study will evaluate the performance of the Ainos Flora Female Vaginal Health Tester by comparing it to the conventional real-time polymerase chain reaction (RT-PCR) and culture methods for the diagnosis of vaginitis to calculate both sensitivity and specificity.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-10-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-08', 'studyFirstSubmitDate': '2022-09-21', 'studyFirstSubmitQcDate': '2022-09-26', 'lastUpdatePostDateStruct': {'date': '2024-04-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-09-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To assess the sensitivity and specificity of Ainos Flora in subjects compared to RT-PCR and culture groups in identifying the types of vaginitis.', 'timeFrame': 'Up to 6 months.', 'description': '* Bacterial infection : Bacterial vaginosis (BV) / Escherichia coli / Trichomonas / Group B streptococcus / Chlamydia trachomatis / Neisseria gonorrhea\n* Fungal infection: Candida albicans\n* Mixed infection: Bacterial and fungal infections coexist\n* No infection: Healthy participant'}], 'secondaryOutcomes': [{'measure': 'Assess the change in sensitivity as the number of subjects is changed.', 'timeFrame': 'Up to 6 months.', 'description': 'When the number of subjects reaches 30,60,90,120, input the collected gas data into the algorithm and calculate the sensitivity. We can then assess the change in sensitivity when the number of subjects changes from 30 to 60, 90, and 120.'}, {'measure': 'Assess the change in specificity as the number of subjects is changed.', 'timeFrame': 'Up to 6 months.', 'description': 'When the number of subjects reaches 30,60,90,120, input the collected gas data into the algorithm and calculate the specificity. We can then assess the change in specificity when the number of subjects changes from 30 to 60, 90, and 120.'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['E-Nose'], 'conditions': ['Vaginal Infection', 'Vaginitis']}, 'descriptionModule': {'briefSummary': "This clinical study aims to train the algorithm and assess the performance of the Ainos Flora Women's Vaginal Health Tester in identifying vaginal infections.", 'detailedDescription': "Ainos Flora Women's Vaginal Health Tester is an in vitro diagnostic device implementing electronic nose technology to detect vaginal infections by examining metabolized gases of vaginal bacteria. The electronic nose system mainly comprises the Micro-Electro-Mechanical Systems (MEMS) gas sensor array and the Artificial Neural Network algorithm. The primary purpose of this study is to train the algorithm and assess the performance of the Ainos Flora in identifying vaginal infections. In addition, the primary outcome measures of this study, including sensitivity and specificity, will be used as a reference for the feasibility and sample size assessment of the next phase of pivotal clinical trials."}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '20 Years', 'genderBased': True, 'genderDescription': 'Women', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female, Age ≥20 to ≤50.\n* Have had sexual experience.\n* Fully understand the subject's informed consent process and be willing to undergo all study-related assessments and procedures.\n\nExclusion Criteria:\n\nWomen who meet any of the following criteria by participant report will be excluded from the study:\n\n* During menstruation.\n* Have performed vaginal washing within three days.\n* Have been treated for vaginal infections within one week."}, 'identificationModule': {'nctId': 'NCT05557318', 'briefTitle': 'Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge', 'organization': {'class': 'INDUSTRY', 'fullName': 'Taiwan Carbon Nano Technology Corporation'}, 'officialTitle': 'Using Micro Electro Mechanical Systems to Detect the Air of Vaginal Discharge', 'orgStudyIdInfo': {'id': 'A202203003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bacterial infections', 'description': 'The subject is infected with at least one of the following pathogens:\n\nBacterial vaginosis (BV) / Escherichia coli / Trichomonas / Group B streptococcus / Chlamydia trachomatis / Neisseria gonorrhoeae', 'interventionNames': ['Device: Vaginal swab for RT-PCR', 'Device: Vaginal swab for culture', 'Device: Metabolic gas signatures detected by Ainos Flora (operated by participant)', 'Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)']}, {'type': 'EXPERIMENTAL', 'label': 'Fungal infection :', 'description': 'The subject is infected with Candida albicans only.', 'interventionNames': ['Device: Vaginal swab for RT-PCR', 'Device: Vaginal swab for culture', 'Device: Metabolic gas signatures detected by Ainos Flora (operated by participant)', 'Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)']}, {'type': 'EXPERIMENTAL', 'label': 'Mixed infection', 'description': 'Bacterial and fungal infections coexist.', 'interventionNames': ['Device: Vaginal swab for RT-PCR', 'Device: Vaginal swab for culture', 'Device: Metabolic gas signatures detected by Ainos Flora (operated by participant)', 'Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)']}, {'type': 'EXPERIMENTAL', 'label': 'No infection', 'description': 'Healthy participant', 'interventionNames': ['Device: Vaginal swab for RT-PCR', 'Device: Vaginal swab for culture', 'Device: Metabolic gas signatures detected by Ainos Flora (operated by participant)', 'Device: Metabolic gas signatures detected by Ainos Flora (operated by medical staff)']}], 'interventions': [{'name': 'Vaginal swab for RT-PCR', 'type': 'DEVICE', 'description': 'Screening for Bacterial vaginosis (BV) / Trichomonas / Chlamydia trachomatis / Candida albicans', 'armGroupLabels': ['Bacterial infections', 'Fungal infection :', 'Mixed infection', 'No infection']}, {'name': 'Vaginal swab for culture', 'type': 'DEVICE', 'description': 'Screening for Group B streptococcus / Neisseria gonorrhoeae / Escherichia coli', 'armGroupLabels': ['Bacterial infections', 'Fungal infection :', 'Mixed infection', 'No infection']}, {'name': 'Metabolic gas signatures detected by Ainos Flora (operated by participant)', 'type': 'DEVICE', 'description': 'The participant operates the Ainos Flora to collect signatures of metabolic gases in the vagina by herself.', 'armGroupLabels': ['Bacterial infections', 'Fungal infection :', 'Mixed infection', 'No infection']}, {'name': 'Metabolic gas signatures detected by Ainos Flora (operated by medical staff)', 'type': 'DEVICE', 'description': "The medical staff operates the Ainos Flora to collect signatures of metabolic gases in the participant's vagina.", 'armGroupLabels': ['Bacterial infections', 'Fungal infection :', 'Mixed infection', 'No infection']}]}, 'contactsLocationsModule': {'locations': [{'zip': '10449', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Dr. Wen-Chu Huang', 'role': 'CONTACT', 'email': 'wjhuang4438@yahoo.com.tw', 'phone': '886-975835350'}, {'name': 'Dr. Wen-Chu Huang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr. Chia-Sui Weng', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'MacKay Memorial Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}, {'zip': '11490', 'city': 'Taipei', 'status': 'RECRUITING', 'country': 'Taiwan', 'contacts': [{'name': 'Dr. Fung-Wei Chang', 'role': 'CONTACT', 'email': 'doc30666@gmail.com', 'phone': '886-2-87923311', 'phoneExt': '12304'}, {'name': 'Dr. Fung-Wei Chang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Dr. Chi-Kang Lin', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Tri-Service General Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'centralContacts': [{'name': 'Dr. Fung-Wei Chang', 'role': 'CONTACT', 'email': 'doc30666@gmail.com', 'phone': '886-2-87923311', 'phoneExt': '12304'}], 'overallOfficials': [{'name': 'Dr. Fung-Wei Chang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tri-Service General Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Taiwan Carbon Nano Technology Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Ainos, Inc. (f/k/a Amarillo Biosciences Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}