Ignite Creation Date:
2025-12-24 @ 7:55 PM
Ignite Modification Date:
2025-12-25 @ 5:30 PM
Study NCT ID:
NCT07226804
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-11-10
First Post:
2025-11-07
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016606', 'term': 'Thyroid Nodule'}], 'ancestors': [{'id': 'D013964', 'term': 'Thyroid Neoplasms'}, {'id': 'D004701', 'term': 'Endocrine Gland Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D006258', 'term': 'Head and Neck Neoplasms'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D013959', 'term': 'Thyroid Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011795', 'term': 'Surveys and Questionnaires'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-26', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2030-08-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-07', 'studyFirstSubmitDate': '2025-11-07', 'studyFirstSubmitQcDate': '2025-11-07', 'lastUpdatePostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-11-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2028-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Quality-of-life Questionnaire', 'timeFrame': 'Through study completion; an average of 1 year'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Thyroid Nodules', 'Pulsed Field Ablation']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center'}]}, 'descriptionModule': {'briefSummary': 'To observe the outcomes of nsPFA therapy to treat benign thyroid nodules.', 'detailedDescription': 'Primary Objectives\n\n• To evaluate the thyroid nodule volume changes over time in participants undergoing nsPFA as part of routine clinical care\n\nSecondary Objectives\n\n* To determine changes in health-related quality of life changes following ultrasound-guided nsPFA\n* To evaluate the ultrasound features of thyroid nodules over time following ultrasound-guided nsPFA.\n* To assess the incidence and nature of complications following ultrasound-guided nsPFA, categorized into Minor and Major complications.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'MD Anderson Cancer Center', 'healthyVolunteers': False, 'eligibilityCriteria': 'Eligibility Criteria\n\n* Scheduled to undergo ultrasound guided nsPFA as standard of care\n* Age 18 to 80 years.\n* Capable of providing independent consent.\n* Presence of biopsy-confirmed benign thyroid nodule , defined as one of the following:\n\n * Benign FNA X 2 or\n * Benign US guided FNA X 1 + benign thyroid nodule ultrasound appearance (TI-RADS 2) or\n * Benign FNA X 1 and radiographic/laboratory evidence of functional nature\n* Nodule measuring \\>2cm in greatest dimension\n* Presence of compressive symptoms reasonably attributable to thyroid nodule (i.e. pressure sensation, dysphagia, dysphonia, respiratory distress)\n* No abnormal cervical lymph nodes during screening visit .\n\nExclusion Criteria\n\n* Age \\<18\n* Patients considered unsuitable for nsPFA by the treating physician'}, 'identificationModule': {'nctId': 'NCT07226804', 'briefTitle': 'Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Nanosecond Pulsed Field Ablation in the Management of Benign Thyroid Nodules', 'orgStudyIdInfo': {'id': '2025-0483'}, 'secondaryIdInfos': [{'id': 'NCI-2025-08362', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Registry'}]}, 'armsInterventionsModule': {'interventions': [{'name': 'Questionnaire', 'type': 'OTHER', 'description': 'patient-reported outcomes questionnaire'}]}, 'contactsLocationsModule': {'locations': [{'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Victoria E Banuchi, MD', 'role': 'CONTACT', 'email': 'vebanuchi@mdanderson.org', 'phone': '346-217-8668'}, {'name': 'Victoria E Banuchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Victoria E Banuchi, MD', 'role': 'CONTACT', 'email': 'vebanuchi@mdanderson.org', 'phone': '346-217-8668'}], 'overallOfficials': [{'name': 'Victoria E Banuchi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}