Here is the design of a clinical trial:

Official Title: Transmyringeal Ventilation Tube Insertion for Unilateral Menière's Disease: a Prospective, Sham-controlled, Double-blinded, Randomized, Clinical Trial

Included conditions:
- Meniere Disease

Study Armgroups:
- {'label': 'Ventilation tube insertion', 'type': 'EXPERIMENTAL', 'description': 'Ventilation tube insertion into the tympanic membrane.', 'interventionNames': ['Procedure: Transmyringeal ventilation tube insertion']}
- {'label': 'Sham-treatment', 'type': 'SHAM_COMPARATOR', 'description': 'Sham-treatment. Manipulation of the tympanic membrane to simulate ventilation tube insertion without performing a ventilation tube insertion.', 'interventionNames': ['Procedure: Sham-treatment']}

Interventions:
- {'type': 'PROCEDURE', 'name': 'Transmyringeal ventilation tube insertion', 'description': 'In both groups, the tympanic membrane will be anesthetized by local application of topical prilocaine (EMLA) or phenol or by infiltration anaesthesia of the outer ear canal. The choice of method is left to the discretion of the surgeon.\n\nFor the experimental group, insertion of a ventilation tube will be performed. An incision is performed, usually in the lower, anterior quadrant of the tympanic membrane and the transmyringeal tube is inserted.', 'armGroupLabels': ['Ventilation tube insertion'], 'otherNames': ['Ventilation tube insertion, grommet insertion']}
- {'type': 'PROCEDURE', 'name': 'Sham-treatment', 'description': 'For the control group, the ENT-specialist will touch the tympanic membrane with an alligator ear forceps to simulate getting a paracentesis. In the same procedure, without having made a paracentesis, a ventilation tube is placed on the tympanic membrane and removed again afterwards. The reason for the above-mentioned is to simulate getting a paracentesis and insertion of a ventilation tube.', 'armGroupLabels': ['Sham-treatment']}

Primary Outcomes:
- {'measure': 'Number of vertigo attacks lasting more than 20 minutes', 'description': 'Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.', 'timeFrame': '3 months'}
- {'measure': 'Number of vertigo attacks lasting more than 20 minutes', 'description': 'Data will be collected as a patient-reported outcome by filling out a weekly self-evaluation of symptoms-questionnaire.', 'timeFrame': '24 months'}

Please estimate the sample size based on the assumption: 
Not explicitly stated in the provided paragraph.
Sample size
          An estimated 104 participants in total or 52 participants in each group will be necessary.
          The primary analysis will be according to the intention-to-treat principle. The trial will be initiated in 2021 and is expected to end in 2025.