Clinical Study of Solo Tympanostomy Tube Device (TTD)
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ClinicalTrials.gov Identifier: NCT02957578 |
Recruitment Status : Unknown
Verified October 2017 by Nottingham University Hospitals NHS Trust.
Recruitment status was: Recruiting
First Posted : November 7, 2016
Last Update Posted : November 1, 2017
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Otitis Media Middle Ear Effusion | Device: Solo TTD | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 20 participants |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Post-Market Approval Study of the Solo Tympanostomy Tube Device |
Study Start Date : | December 2016 |
Estimated Primary Completion Date : | September 2018 |
Estimated Study Completion Date : | November 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Solo TTD
Placement of tympanostomy tube with Solo TTD
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Device: Solo TTD
Placement of tympanostomy tube with Solo TTD |
- Intraoperative Device Success [ Time Frame: Intraoperative ]Number of ears in which tube placement is achieved with the Solo TTD
- Conversion from moderate sedation [ Time Frame: Intraoperative ]Number of patients requiring conversion from moderate sedation to general anaesthesia

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Ages Eligible for Study: | up to 18 Years (Child, Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Basic Inclusion Criteria:
- Listed for bilateral tympanostomy tube insertion only
Basic Exclusion Criteria:
- Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place.
- Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD
- Patients in whom a reliable audiogram is not possible

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02957578
Contact: Maria Koufali | researchsponsor@nuh.nhs.uk | ||
Contact: Olive O'Driscoll | clinical@aventamed.com |
United Kingdom | |
Nottingham University Hospitals NHS Trust | Recruiting |
Nottingham, United Kingdom, NG7 2UH | |
Contact: Anand Kasbekar clinical@aventamed.com |
Principal Investigator: | Owen Judd | Royal Derby Hospitals NHS Foundation Trust | |
Principal Investigator: | Tawakir Kamani | Sheffield Children's Hospital NHS Foundation Trust | |
Study Chair: | Matija Daniel | Nottingham University Hospitals NHS Trust | |
Principal Investigator: | Anand Kasbekar | Nottingham University Hospitals NHS Trust |
Responsible Party: | Nottingham University Hospitals NHS Trust |
ClinicalTrials.gov Identifier: | NCT02957578 History of Changes |
Other Study ID Numbers: |
13IH026 208475 ( Other Identifier: IRAS ) |
First Posted: | November 7, 2016 Key Record Dates |
Last Update Posted: | November 1, 2017 |
Last Verified: | October 2017 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | No Plan to Share Individual Participant Data |
Tympanostomy Tube Ventilation Tube Grommet Otitis Media Middle Ear Effusion |
Otitis Otitis Media Otitis Media with Effusion Ear Diseases Otorhinolaryngologic Diseases Diazepam Adjuvants, Anesthesia Anticonvulsants Antiemetics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Gastrointestinal Agents Hypnotics and Sedatives |
Central Nervous System Depressants Muscle Relaxants, Central Neuromuscular Agents Anti-Anxiety Agents Tranquilizing Agents Psychotropic Drugs Anesthetics, Intravenous Anesthetics, General Anesthetics GABA Modulators GABA Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |