Ignite Creation Date:
2025-12-25 @ 12:27 AM
Ignite Modification Date:
2025-12-25 @ 10:32 PM
Study NCT ID:
NCT01733667
Status:
COMPLETED
Last Update Posted:
2013-06-05
First Post:
2012-11-21
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-06', 'completionDateStruct': {'date': '2013-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-06-03', 'studyFirstSubmitDate': '2012-11-21', 'studyFirstSubmitQcDate': '2012-11-26', 'lastUpdatePostDateStruct': {'date': '2013-06-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-11-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Miller synechia score at 8 weeks', 'timeFrame': '8 weeks post endoscopic sinus surgery', 'description': 'Miller synechia score at 8 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 8 weeks judged by an independent evaluator)'}], 'secondaryOutcomes': [{'measure': 'Miller Score at 4 & 8 weeks', 'timeFrame': '4 & 8 weeks post endoscopic sinus surgery', 'description': '* Miller synechia score at 4 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 4 weeks judged by an independent evaluator)\n* Total mean Miller score at 8 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['synechia', 'Fess', 'sinus surgery'], 'conditions': ['Synechia']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.', 'detailedDescription': 'MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Subject is between the ages of 18 and 65 years\n2. Subject scheduled to undergo bilateral endoscopic sinus surgery\n3. Subject signs IRB-approved informed consent form\n4. Subject agrees to comply with all study-related procedures\n\nExclusion Criteria:\n\n1. History of removal of one or both middle turbinates\n2. Significant sinonasal polyps\n3. Presence of marked septal asymmetry\n4. Presence of significant concha bullosa, which requires surgical excision\n5. Presence of non-viable tissue at the implantation site\n6. Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis\n7. Known or suspected allergy to device components\n8. Participating in another clinical trial which could affect the healing of the middle turbinate\n9. Uncontrolled diabetes\n10. Known or suspected use of illicit drugs\n11. Known or suspected alcoholism\n12. Other medical illness that could prevent follow-up or increase the risk of surgery\n13. Pregnant or unwilling to take pregnancy prevention measures\n14. Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea"}, 'identificationModule': {'nctId': 'NCT01733667', 'acronym': 'MISTY', 'briefTitle': 'A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery', 'organization': {'class': 'INDUSTRY', 'fullName': 'ENTrigue Surgical, Inc.'}, 'officialTitle': 'A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery', 'orgStudyIdInfo': {'id': 'CSA2011-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'MediENT', 'description': 'Right or left sinus cavity where MediENT will be place after randomization.', 'interventionNames': ['Device: MediENT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MeroPack', 'description': 'Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned.', 'interventionNames': ['Device: MeroPack']}], 'interventions': [{'name': 'MediENT', 'type': 'DEVICE', 'otherNames': ['MeroPack'], 'description': 'MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT', 'armGroupLabels': ['MediENT']}, {'name': 'MeroPack', 'type': 'DEVICE', 'description': 'MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT', 'armGroupLabels': ['MeroPack']}]}, 'contactsLocationsModule': {'locations': [{'zip': '93720', 'city': 'Fresno', 'state': 'California', 'country': 'United States', 'facility': 'Central California ENT Medical Group', 'geoPoint': {'lat': 36.74773, 'lon': -119.77237}}, {'zip': '80909', 'city': 'Colorado Springs', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado ENT & Allergy', 'geoPoint': {'lat': 38.83388, 'lon': -104.82136}}, {'zip': '40207', 'city': 'Louisville', 'state': 'Kentucky', 'country': 'United States', 'facility': 'Advanced ENT and Allergy', 'geoPoint': {'lat': 38.25424, 'lon': -85.75941}}, {'zip': '75079', 'city': 'McKinney', 'state': 'Texas', 'country': 'United States', 'facility': 'ENT Associates of Texas', 'geoPoint': {'lat': 33.19762, 'lon': -96.61527}}, {'zip': '78229', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Ear, Nose & Throat Clinics of San Antonio', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ENTrigue Surgical, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}