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Clinical Study of the Solo Tympanostomy Tube Device

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ClinicalTrials.gov Identifier: NCT03722160
Recruitment Status : Recruiting
First Posted : October 26, 2018
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
AventaMed DAC

Brief Summary:
The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

Condition or disease Intervention/treatment Phase
Ear Infection Otitis Media Device: Solo TympanostomyTube Device Not Applicable

Detailed Description:
The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 27 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Study of the Solo Tympanostomy Tube Device
Actual Study Start Date : September 13, 2018
Estimated Primary Completion Date : September 2019
Estimated Study Completion Date : September 2019

Resource links provided by the National Library of Medicine

Drug Information available for: Diazepam

Arm Intervention/treatment
Solo Tympanostomy Tube Device
The Solo Tympanostomy Tube Device is a disposable surgical tool designed to deliver a tympanostomy tube (grommet) into the tympanic membrane of patients undergoing a tympanostomy tube placement procedure
Device: Solo TympanostomyTube Device
The Solo Tympanostomy Tube Device is intended to deliver a tympanostomy tube through the tympanic membrane of a patient during a tympanostomy procedure.




Primary Outcome Measures :
  1. Successful delivery of the tympanostomy tube by the Solo Tympanostomy Tube Device [ Time Frame: Intra-operative ]
    The number of ears in which the Solo Tympanostomy Tube Device tube is placed

  2. Rate of Adverse Events [ Time Frame: Intra-operative, 2-6 weeks post-operative ]
    The number and type of Adverse Events



Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Listed for bilateral tympanostomy tube insertion

Exclusion Criteria:

  • Anatomy that precludes sufficient visualisation of both the left and right eardrum
  • Narrow ear canals
  • Anatomy that precludes safe access to both the left and right eardrum
  • Membrane >25% sclerosis
  • Congenital or craniofacial abnormalities
  • No available baseline audiometry and tympanometry

Information from the National Library of Medicine

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): NCT03722160


Contacts
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Contact: Olive O'Driscoll +353 21 492 8980 clinical@aventamed.com

Locations
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Italy
IRCCS Burlo-Garofolo Not yet recruiting
Trieste, Italy
Contact: Domenico Leonardo Grasso         
United Kingdom
Royal Derby Hospital Recruiting
Derby, United Kingdom
Queen's Medical Centre Completed
Nottingham, United Kingdom
Sponsors and Collaborators
AventaMed DAC
Investigators
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Study Chair: Matija Daniel Queen's Medical Centre

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Responsible Party: AventaMed DAC
ClinicalTrials.gov Identifier: NCT03722160     History of Changes
Other Study ID Numbers: CSP001
First Posted: October 26, 2018    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: There is no plan to make IPD available to other researchers

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Otitis
Otitis Media
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