Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:45 AM
Study NCT ID:
NCT07369050
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-01-27
First Post:
2026-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 48}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2030-09-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-01-23', 'studyFirstSubmitDate': '2026-01-23', 'studyFirstSubmitQcDate': '2026-01-23', 'lastUpdatePostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-01-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and Adverse Events (AEs)', 'timeFrame': 'Through study completion; an average of 1 year', 'description': 'Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Laryngectomy']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.mdanderson.org', 'label': 'MD Anderson Cancer Center Website'}]}, 'descriptionModule': {'briefSummary': 'The goal of this clinical research study is to learn if regular use of Provox® ActiValve® by patients after a total laryngectomy with TEP can decrease the number of VP device replacements needed annually.', 'detailedDescription': 'Primary Objective:\n\nTo determine whether routine use of Provox® ActiValve® voice prosthesis decreases annual number of clinical procedures to exchange VP in indwelling voice prosthesis users after total laryngectomy with TEP.\n\nSecondary Objectives:\n\n1. To compare outcomes, adverse events, and costs associated with routine use of Provox® ActiValve® (experimental) versus standard indwelling voice prostheses (comparator)\n2. To compare outcomes, adverse events, and costs associated with prophylactic exchange of Provox® ActiValve® versus routine use of Provox® ActiValve® (experimental) or standard indwelling voice prostheses (comparator)\n\nExploratory objectives:\n\n1. To explore relationships between clinicodemographic features and device/TEP function\n2. To explore relationships between pharyngoesophageal pressures via manometry and device/TEP function\n3. To explore relationships between oral/tracheal microbiome and device/TEP function\n4. To describe novel use of prophylactic exchange of Provox® ActiValve®'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adults ≥ 18 years of age status post total laryngectomy with tracheoesophageal puncture\n2. Using or ready for fit of indwelling voice prosthesis\n3. No evidence of disease (NED) in head and neck\n4. At least 6 months since cancer treatment\n5. TEP tract length 4.5 to 12.5mm at time of enrollment\\*\n\n * The range reflects the available device sizes for the Provox® ActiValve® . Eligibility is determined by confirming that the patient is appropriately fitted with a VP within this size range, based on the site\'s standard clinical practice (e.g. appearance/fit and/or depth gauge).\n\nExclusion Criteria:\n\n1. History of recurrent leak around voice prosthesis and/or severely enlarged puncture (within last 12 months)\n2. History of recurrent VP extrusion (within last 12 months)\n3. Currently using specialty Activalve voice prosthesis as a "problem solver" due to poor device life as defined in the Instructions for Use (IFU)\n4. History of recurrent early VP leak within 4 to 8 weeks of fit (within last 12 months)\n5. Active malignancy in head and neck and/or chest at the time of enrollment\n6. Receiving or planned for head and neck radiation therapy (RT) at the time of enrollment\n7. Receiving regular magnetic resonance imaging (MRI) for cancer surveillance or other medical reasons\n8. Planned regular VP exchanges at outside facility within next 12 months\n9. History of gastric pull-up reconstruction'}, 'identificationModule': {'nctId': 'NCT07369050', 'briefTitle': 'A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses', 'organization': {'class': 'OTHER', 'fullName': 'M.D. Anderson Cancer Center'}, 'officialTitle': 'Is the Provox ActiValve Only a Problem Solver? A Randomized Trial Comparing Routine Use of the ActiValve to Standard Voice Prostheses After Total Laryngectomy With Tracheoesophageal Puncture', 'orgStudyIdInfo': {'id': '2025-1610'}, 'secondaryIdInfos': [{'id': 'NCI-2026-00404', 'type': 'OTHER', 'domain': 'NCI-CTRP Clinical Trials Registry'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Routine "as needed" exchange with Provox ActiValve', 'description': 'Participants randomized to Arm 1 will receive a Provox® ActiValve® at the first VP replacement after randomization', 'interventionNames': ['Device: Provox® ActiValve®']}, {'type': 'EXPERIMENTAL', 'label': 'Standard indwelling VP with optional cross-over to Provox ActiValve', 'description': 'Participants randomized into Arm 2 will receive their standard VP exchanges on "as needed" basis through the 12-month study period.', 'interventionNames': ['Device: Provox® ActiValve®']}, {'type': 'EXPERIMENTAL', 'label': 'Prophylactic Provox ActiValve exchange', 'description': 'Participants randomized to Arm 3 will receive a Provox® ActiValve® at the first VP replacement after randomization and prophylactic exchange will target replacement of the device between 9 months +/-1 month after fit.', 'interventionNames': ['Device: Provox® ActiValve®']}], 'interventions': [{'name': 'Provox® ActiValve®', 'type': 'DEVICE', 'description': 'Participants experiencing early leakage with previous voice prostheses (device life less than 4-8 weeks). The device reduced the need for frequent replacements in a majority of users but not in all"7. The Light valve strength will be used in this trial.', 'armGroupLabels': ['Prophylactic Provox ActiValve exchange', 'Routine "as needed" exchange with Provox ActiValve', 'Standard indwelling VP with optional cross-over to Provox ActiValve']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77090', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'contacts': [{'name': 'Katherine A Hutcheson, PHD', 'role': 'CONTACT', 'email': 'karnold@mdanderson.org', 'phone': '713-792-6513'}, {'name': 'Katherine A Hutcheson, PHD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'The University of Texas M. D. Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}], 'centralContacts': [{'name': 'Katherine A Hutcheson, PHD', 'role': 'CONTACT', 'email': 'karnold@mdanderson.org', 'phone': '(713) 792-6513'}], 'overallOfficials': [{'name': 'Katherine A Hutcheson, PHD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'M.D. Anderson Cancer Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'M.D. Anderson Cancer Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}