Ignite Creation Date:
2025-12-24 @ 5:14 PM
Ignite Modification Date:
2026-02-22 @ 4:13 AM
Study NCT ID:
NCT02087150
Status:
COMPLETED
Last Update Posted:
2024-07-12
First Post:
2014-03-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'pchen126@its.jnj.com', 'phone': '949-453-6408', 'title': 'Patricia Chen', 'organization': 'Acclarent'}, 'certainAgreement': {'restrictionType': 'GT60', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse events were collected for the procedure and at each follow-up visit at 2 weeks, 6 weeks, 12 weeks, 24 weeks, and 52 weeks post-treatment', 'description': 'AEs in MM subjects prior to crossover are reported in the "Medical Management" arm (n=80). AEs in MM subjects after a crossover ETBC procedure are reported in the "Crossover MM" arm (n=70). To provide a robust safety profile, events are additionally presented in an "ALL ETBC" safety cohort, which consists of all subjects treated with the ETBC in the lead-in phase (n=80), randomized ETBC arm (n=149), and randomized MM arm who crossed over (n=70) for a total of 299 subjects in the "ALL ETBC" arm.', 'eventGroups': [{'id': 'EG000', 'title': 'Lead-In', 'description': 'Subjects enrolled in the Lead-in group and treated with the ETBC', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 30, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 2}, {'id': 'EG001', 'title': 'Randomized ETBC', 'description': 'Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)', 'otherNumAtRisk': 149, 'deathsNumAtRisk': 149, 'otherNumAffected': 58, 'seriousNumAtRisk': 149, 'deathsNumAffected': 1, 'seriousNumAffected': 5}, {'id': 'EG002', 'title': 'Crossover MM', 'description': 'Subjects enrolled and randomized to treatment with Medical Management (MM) only who crossed over to have treatment with the ETBC after the 6-week follow-up visit', 'otherNumAtRisk': 70, 'deathsNumAtRisk': 70, 'otherNumAffected': 20, 'seriousNumAtRisk': 70, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'ALL ETBC', 'description': 'All subjects in the lead-in phase, subjects randomized to the investigational arm who received treatment with the ETBC, and subjects in the control arm who crossed over to have treatment with the ETBC', 'otherNumAtRisk': 299, 'deathsNumAtRisk': 299, 'otherNumAffected': 108, 'seriousNumAtRisk': 299, 'deathsNumAffected': 1, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Randomized MM', 'description': 'Subjects enrolled and randomized to treatment with Medical Management (MM) only', 'otherNumAtRisk': 80, 'deathsNumAtRisk': 80, 'otherNumAffected': 18, 'seriousNumAtRisk': 80, 'deathsNumAffected': 0, 'seriousNumAffected': 1}], 'otherEvents': [{'term': 'Coronary artery disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Conductive deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Deafness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Ear discomfort', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 5, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Ear pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Eustachian tube disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Eustachian tube dysfunction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Eustachian tube obstruction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Eustachian tube patulous', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Hypoacusis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Middle ear effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Otorrhea', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Tinnitus', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Tympanic membrane perforation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Vertigo', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Tympanic membrane disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Ear and labyrinth disorders'}, {'term': 'Oesophageal spasm', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Tooth impacted', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Gastroesophageal reflux disease', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Glossodynia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Inguinal hernia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Toothache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Vomiting', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Gastrointestinal disorders'}, {'term': 'Adverse drug reaction', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders'}, {'term': 'Effusion', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Facial pain', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Oedema', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Pyrexia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Sensation of foreign body', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'General disorders'}, {'term': 'Herpes zoster', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'tooth abscess', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Viral upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Acute sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Bronchitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'Cellulitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Chronic sinusitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Conjunctivitis infective', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Ear infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 2, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Hordeolum', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations'}, {'term': 'Infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 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'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Bipolar I disorder', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 149, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 70, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 299, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 80, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized ETBC', 'description': 'Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)'}, {'id': 'OG001', 'title': 'Randomized MM', 'description': 'Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits'}], 'classes': [{'categories': [{'measurements': [{'value': '73', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Week Follow-Up Visit', 'description': 'The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).'}, {'type': 'SECONDARY', 'title': 'Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '143', 'groupId': 'OG000'}, {'value': '72', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized ETBC', 'description': 'Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)'}, {'id': 'OG001', 'title': 'Randomized MM', 'description': 'Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits'}], 'classes': [{'categories': [{'measurements': [{'value': '128', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 Week Follow-Up Visit', 'description': 'The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Primary Analysis Cohort (PAC): The PAC is defined as all randomized subjects who receive a study treatment for which they are randomized and have completed their primary analysis visits (i.e. completer analysis with baseline and 6 week tympanogram).'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized ETBC', 'description': 'Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)'}, {'id': 'OG001', 'title': 'Randomized MM', 'description': 'Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits'}], 'classes': [{'title': '12 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '136', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '64', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}, {'title': '24 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '78', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '52 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '128', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '71', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12, 24, 52 Week Follow-Up', 'description': 'Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized ETBC', 'description': 'Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)'}, {'id': 'OG001', 'title': 'Randomized MM', 'description': 'Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits'}], 'classes': [{'title': '12 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '118', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}, {'title': '24 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '134', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '123', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}, {'title': '52 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '111', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '12,24,52 Week Follow-Up Visit', 'description': 'Evaluation of subjects achieving at least a MID level improvement of 0.5 points at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects achieving at least a MID level improvement at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)'}, {'type': 'OTHER_PRE_SPECIFIED', 'title': 'Exploratory Endpoint: WPAI at 6,12,24,52 Weeks', 'denoms': [{'units': 'Participants', 'counts': [{'value': '149', 'groupId': 'OG000'}, {'value': '80', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Randomized ETBC', 'description': 'Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)'}, {'id': 'OG001', 'title': 'Randomized MM', 'description': 'Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '146', 'groupId': 'OG000'}, {'value': '77', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '45.3', 'spread': '32.8', 'groupId': 'OG000'}, {'value': '50.4', 'spread': '31.1', 'groupId': 'OG001'}]}]}, {'title': '6 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '70', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '16.6', 'spread': '23.6', 'groupId': 'OG000'}, {'value': '47.1', 'spread': '32.0', 'groupId': 'OG001'}]}]}, {'title': '12 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '133', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '10.9', 'spread': '16.1', 'groupId': 'OG000'}, {'value': '38.2', 'spread': '27.5', 'groupId': 'OG001'}]}]}, {'title': '24 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '130', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '12.0', 'spread': '19.5', 'groupId': 'OG000'}, {'value': '33.8', 'spread': '37.0', 'groupId': 'OG001'}]}]}, {'title': '52 Week Visit', 'denoms': [{'units': 'Participants', 'counts': [{'value': '124', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '9.1', 'spread': '18.2', 'groupId': 'OG000'}, {'value': '17.5', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6,12,24,52 Week Follow-Up', 'description': "Evaluation of subjects' work and activity impairment before and after treatment in both the investigational arm and the control arm. The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-question patient-reported general health assessment of productivity and activity impairment. WPAI results are expressed as the percentage of impairment from 0 to 100 where higher numbers indicate greater impairment or less productivity. Due to an error in the WPAI electronic data collection form, 2 questions were not visible to many subjects resulting in a significant amount of missing data for all scores except non-work activity impairment. Therefore, only the non-work activity impairment results are presented. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.", 'unitOfMeasure': 'Percentage of Impairment', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Per-Protocol Cohort: All randomized subjects expect those who: • Did not complete a baseline or respective follow-up assessment for the time point under analysis • Did not receive the treatment for which they were randomized • Had any major protocol deviation(s)'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Lead-In', 'description': 'Subjects enrolled in Lead-In Group'}, {'id': 'FG001', 'title': 'Randomized ETBC', 'description': 'Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)'}, {'id': 'FG002', 'title': 'Randomized MM', 'description': 'Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '81'}, {'groupId': 'FG001', 'numSubjects': '162'}, {'groupId': 'FG002', 'numSubjects': '80'}]}, {'type': 'Had a Lead-in or Randomized ETBC Proc', 'achievements': [{'groupId': 'FG000', 'numSubjects': '80'}, {'groupId': 'FG001', 'numSubjects': '149'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Received a Crossover MM ETBC Procedure', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '70'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '128'}, {'groupId': 'FG002', 'numSubjects': '69'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '11'}]}], 'dropWithdraws': [{'type': 'Death', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '6'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '7'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}, {'groupId': 'FG002', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Procedure not done', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '13'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'F/U not completed w/in study window', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '1'}]}, {'type': 'Other', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'Pt moved out of town', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '81', 'groupId': 'BG000'}, {'value': '162', 'groupId': 'BG001'}, {'value': '80', 'groupId': 'BG002'}, {'value': '323', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Lead-In', 'description': 'Subjects enrolled in Lead-In Group'}, {'id': 'BG001', 'title': 'Randomized ETBC', 'description': 'Subjects enrolled and randomized to treatment with the Eustachian Tube Balloon Catheter (ETBC) plus Medical Management (MM)'}, {'id': 'BG002', 'title': 'Randomized MM', 'description': 'Subjects enrolled and randomized to treatment with medical management (MM) only. Subjects randomized to the MM arm were allowed the option to cross-over to have a procedure with the ETBC after completion of the 6 week follow-up visit. Cross-over subject were followed to 12 weeks post-procedure only. Thereafter, they were exited from the study and not required to undergo the 24 week and 52 week follow-up visits'}, {'id': 'BG003', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '53.7', 'spread': '14.1', 'groupId': 'BG000'}, {'value': '55.6', 'spread': '14.3', 'groupId': 'BG001'}, {'value': '57.7', 'spread': '13.4', 'groupId': 'BG002'}, {'value': '55.6', 'spread': '14.1', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '77', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '155', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '85', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}, {'value': '168', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '12', 'groupId': 'BG003'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '80', 'groupId': 'BG000'}, {'value': '153', 'groupId': 'BG001'}, {'value': '78', 'groupId': 'BG002'}, {'value': '311', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Black or African American', 'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}, {'value': '23', 'groupId': 'BG003'}]}, {'title': 'White', 'measurements': [{'value': '77', 'groupId': 'BG000'}, {'value': '147', 'groupId': 'BG001'}, {'value': '67', 'groupId': 'BG002'}, {'value': '291', 'groupId': 'BG003'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '7', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 323}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-02-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2017-01-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-07-10', 'studyFirstSubmitDate': '2014-03-06', 'resultsFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2014-03-12', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2018-12-17', 'studyFirstPostDateStruct': {'date': '2014-03-14', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2019-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Exploratory Endpoint: Number of Randomized Subjects With Normalized Tympanometry at 12.24,52 Weeks', 'timeFrame': '12, 24, 52 Week Follow-Up', 'description': 'Evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects experiencing normalization of tympanometry at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.'}, {'measure': 'Exploratory Endpoint: Number of Randomized Subjects With ETDQ-7 Improvement at 12, 24, 52 Weeks', 'timeFrame': '12,24,52 Week Follow-Up Visit', 'description': 'Evaluation of subjects achieving at least a MID level improvement of 0.5 points at 12 weeks, 24 weeks, and 52 weeks post-treatment in the investigational arm and evaluation of subjects achieving at least a MID level improvement at 12 weeks, 24 weeks, and 52 weeks post-randomization in the control arm. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits.'}, {'measure': 'Exploratory Endpoint: WPAI at 6,12,24,52 Weeks', 'timeFrame': '6,12,24,52 Week Follow-Up', 'description': "Evaluation of subjects' work and activity impairment before and after treatment in both the investigational arm and the control arm. The Work Productivity and Activity Impairment (WPAI) questionnaire is a 6-question patient-reported general health assessment of productivity and activity impairment. WPAI results are expressed as the percentage of impairment from 0 to 100 where higher numbers indicate greater impairment or less productivity. Due to an error in the WPAI electronic data collection form, 2 questions were not visible to many subjects resulting in a significant amount of missing data for all scores except non-work activity impairment. Therefore, only the non-work activity impairment results are presented. As MM subjects were allowed to receive a crossover procedure after their 6-week follow-up visit, there is a limited number of MM subjects who completed the 12/24/52 visits."}], 'primaryOutcomes': [{'measure': 'Primary Efficacy Analysis: Number of Randomized Subjects With Tympanogram Normalization at 6 Weeks', 'timeFrame': '6 Week Follow-Up Visit', 'description': 'The primary efficacy analysis compares randomized subjects with tympanogram normalization (Types B or C normalized to Type A) in all indicated ears at 6 weeks in the investigational arm versus the control arm. Per protocol, tympanogram types are defined as follows: Type A: Peak compliance occurs between +50 and -100 daPa, with minimum peak height of 0.2ml. Indicates NORMAL middle ear function Type B: No sharp peak and a rounded line. Indicates ABNORMAL middle ear function Type C: Peak compliance occurs beyond -100 daPa. Indicates ABNORMAL middle ear function'}], 'secondaryOutcomes': [{'measure': 'Secondary Efficacy Endpoint: Number of Randomized Subjects With MID Improvement From Baseline of 0.5 Points or More at 6 Weeks', 'timeFrame': '6 Week Follow-Up Visit', 'description': 'The secondary efficacy endpoint will consist of comparison of subjects achieving at least a minimally important difference (MID) level improvement of 0.5 points on the ETDQ-7 at 6 weeks post-treatment in the investigational arm versus the proportion of subjects achieving at least an MID level improvement on the ETDQ-7 at 6 weeks post-randomization in the control arm The ETDQ-7 is a seven-item ETD specific validated quality of life survey. A mean item score of greater or equal to 2.1 indicates the presence of ETD.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Eustachian Tube Dysfunction']}, 'referencesModule': {'references': [{'pmid': '40008607', 'type': 'DERIVED', 'citation': 'Swords C, Smith ME, Patel A, Norman G, Llewellyn A, Tysome JR. Balloon dilatation of the Eustachian tube for obstructive Eustachian tube dysfunction in adults. Cochrane Database Syst Rev. 2025 Feb 26;2(2):CD013429. doi: 10.1002/14651858.CD013429.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine whether Eustachian tube dilation in conjunction with medical management or medical management alone is effective for treating Eustachian tube dysfunction.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '22 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult male or female aged 22 years and older\n* Persistent Eustachian tube dysfunction\n* Failure of medical management\n* Positive diagnosis of ETD\n* Absence of internal carotid artery (ICA) dehiscence\n* Able to read and understand English\n\nExclusion Criteria:\n\n* Females who are pregnant or lactating\n* Anatomy that requires an adjunctive surgical procedure\n* Concomitant nasal or sinus procedures planned on the same day as surgical procedure\n* Concomitant ear procedures planned on the same day as surgical procedure\n* History of major surgery of the head or neck within four (4) months prior to surgery\n* History of patulous ET\n* History of fluctuating sensorineural hearing loss\n* Active acute otitis media\n* Tympanic membrane perforation\n* Tympanosclerosis\n* Acute upper respiratory infection\n* Temporomandibular joint disorder\n* Cleft palate\n* Craniofacial syndrome\n* Cystic fibrosis\n* Ciliary dysmotility syndrome\n* Systemic mucosal or immunodeficiency disease\n* Intolerance of medication for ETD\n* Prior intervention of Eustachian tube'}, 'identificationModule': {'nctId': 'NCT02087150', 'acronym': 'ELLIOTT', 'briefTitle': 'Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter', 'organization': {'class': 'INDUSTRY', 'fullName': 'Integra LifeSciences Corporation'}, 'officialTitle': 'A Randomized Clinical Study of Safety and Efficacy for the Eustachian Tube Balloon Catheter (ELLIOTT)', 'orgStudyIdInfo': {'id': 'CPR005029'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Medical management (MM)', 'description': 'Medical management will consist of 6 weeks of daily intranasal steroid (triamcinolone acetonide)'}, {'type': 'EXPERIMENTAL', 'label': 'Eustachian tube balloon catheter (ETBC) plus MM', 'description': 'Eustachian tube dilation with the ETBC plus medical management', 'interventionNames': ['Device: Acclarent Eustachian Tube Balloon Catheter (ETBC)']}], 'interventions': [{'name': 'Acclarent Eustachian Tube Balloon Catheter (ETBC)', 'type': 'DEVICE', 'armGroupLabels': ['Eustachian tube balloon catheter (ETBC) plus MM']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94303', 'city': 'East Palo Alto', 'state': 'California', 'country': 'United States', 'facility': 'California Ear Institute', 'geoPoint': {'lat': 37.46883, 'lon': -122.14108}}, {'zip': '20006', 'city': 'Washington D.C.', 'state': 'District of Columbia', 'country': 'United States', 'facility': 'George Washington Medical Faculty Associates, ENT Center', 'geoPoint': {'lat': 38.89511, 'lon': -77.03637}}, {'zip': '33487', 'city': 'Boca Raton', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT of South Florida', 'geoPoint': {'lat': 26.35869, 'lon': -80.0831}}, {'zip': '33437', 'city': 'Boynton Beach', 'state': 'Florida', 'country': 'United States', 'facility': 'ENT of South Florida', 'geoPoint': {'lat': 26.52535, 'lon': -80.06643}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Florida Ear & Sinus Center', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '30308', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'ENT of Georgia', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '30309', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Piedmont Ear, Nose & Throat &Related Allergy', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '46052', 'city': 'Lebanon', 'state': 'Indiana', 'country': 'United States', 'facility': 'Witham Health Services', 'geoPoint': {'lat': 40.04837, 'lon': -86.46917}}, {'zip': '71303', 'city': 'Alexandria', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Red River Sinus Center', 'geoPoint': {'lat': 31.31129, 'lon': -92.44514}}, {'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Our Lady of the Lake Hospital', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Children's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '55130', 'city': 'Saint Paul', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Health Partners Specialty Center', 'geoPoint': {'lat': 44.94441, 'lon': -93.09327}}, {'zip': '39564', 'city': 'Ocean Springs', 'state': 'Mississippi', 'country': 'United States', 'facility': 'The Sinus Center of the South', 'geoPoint': {'lat': 30.41131, 'lon': -88.82781}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Vijay Anand, LLC', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '11777', 'city': 'Port Jefferson', 'state': 'New York', 'country': 'United States', 'facility': 'Ear, Nose, Throat and Allergy Associates, LLP', 'geoPoint': {'lat': 40.94649, 'lon': -73.06927}}, {'zip': '10601', 'city': 'White Plains', 'state': 'New York', 'country': 'United States', 'facility': 'Ear, Nose, Throat and Allergy Associates, LLP', 'geoPoint': {'lat': 41.03399, 'lon': -73.76291}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Charlotte Eye, Ear, Nose &Throat Associates', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '27609', 'city': 'Raleigh', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Ear and Hearing Clinic', 'geoPoint': {'lat': 35.7721, 'lon': -78.63861}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Healthcare, PLLC', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Ear Medical Group', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}, {'zip': '53716', 'city': 'Monona', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Meriter Monona', 'geoPoint': {'lat': 43.06222, 'lon': -89.33401}}], 'overallOfficials': [{'name': 'Dennis Poe, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Boston Children's Hospital"}, {'name': 'Vijay Anand, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Memorial Sloan Kettering Cancer Center and Weill Medical College of Cornell University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'A publication is planned'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Integra LifeSciences Corporation', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Acclarent', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}