Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01444391
Other study ID # CPR005022
Secondary ID
Status Completed
Phase N/A
First received September 23, 2011
Last updated September 20, 2014
Start date October 2011
Est. completion date June 2012

Study information

Verified date September 2014
Source Acclarent
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.


Recruitment information / eligibility

Status Completed
Enrollment 42
Est. completion date June 2012
Est. primary completion date May 2012
Accepts healthy volunteers No
Gender Both
Age group 6 Months and older
Eligibility Inclusion Criteria:

- Scheduled to undergo tympanostomy tube insertion

- At least 6 months old

- Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)

- No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion Criteria:

- Pregnant or lactating females

- Significantly atrophic, bimeric, or completely atelectatic tympanic membrane

- Otitis externa

- Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal

- Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane

- Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)

- Anatomy that precludes sufficient visualization of and access to the tympanic membrane

- Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Tympanostomy tube placement (Acclarent iontophoresis device)
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device

Locations

Country Name City State
United States South Coast Ear, Nose, & Throat Port St. Lucie Florida

Sponsors (1)

Lead Sponsor Collaborator
Acclarent

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects With Procedural, Serious and Device-related Adverse Events. Adverse events which are procedural, serious, and device-related. Procedure through 2 weeks post-procedure Yes
Primary Device Success Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis. Day 0 (day of procedure) No
Secondary Procedure Success Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis. Day 0 (day of procedure) No
Secondary Procedure Tolerability Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System. Day 0 (day of procedure) No
Secondary Tube Retention Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit. 2 weeks post-procedure No
See also
  Status Clinical Trial Phase
Completed NCT04016051 - Acceptance of Clarithromycin in a Straw Compared to Syrup in Children With Upper Respiratory Tract Infections Phase 3
Completed NCT02452164 - Family MobilePhone Otoscopy in Diagnostics of Otitis Media N/A
Completed NCT01199016 - Effect of Prevnar 13 on Ear Infections in Children Phase 4
Terminated NCT00778063 - Study Using Dexmedetomidine to Decreases Emergence Delirium in Pediatric Patients N/A
Completed NCT00195611 - Study of Streptococcus Pneumoniae in Nose and Throats of Infants With Acute Otitis Media Phase 4
Recruiting NCT03722160 - Clinical Study of the Solo Tympanostomy Tube Device N/A
Recruiting NCT04447521 - Surveillance of Non-invasive Streptococcus Pneumoniae Infections in Belgium
Active, not recruiting NCT05127161 - Broad Implementation of Outpatient Stewardship N/A
Completed NCT02600559 - Open-Label Study of OTO-201 in Pediatric Subjects With a History of Otitis Media Requiring Tympanostomy Tubes Phase 3
Enrolling by invitation NCT01437436 - The Effect of Obesity on Ventilation Tube Insertion N/A
Completed NCT01003210 - Homeopathic Ear Drops for Otitis Media Study N/A
Completed NCT00768534 - Study Evaluating Microbiological Analysis of Spontaneous Draining Acute Otitis Media N/A
Recruiting NCT00393159 - The Influence of The Ear Popper on Serous Otitis Media and on the Accompanying Conductive Hearing Loss in Children Phase 4
Completed NCT00617682 - Maternal Immunization To Prevent Infant Otitis Media Phase 1/Phase 2
Withdrawn NCT00956748 - N-Acetylcysteine as an Adjunct for Refractory Chronic Suppurative Otitis Media Phase 4
Withdrawn NCT01908764 - Pharmacokinetic Study of AL-60371 Otic Suspension in Pediatric Subjects Following Tympanostomy Tube Surgery Phase 1
Recruiting NCT01619462 - Safety and Immunogenicity of 10-valent and 13-valent Pneumococcal Conjugate Vaccines in Papua New Guinean Children Phase 3
Completed NCT02616458 - The Impact of Ear Pain Anticipatory Guidance Counseling on Otitis Related Visits in a Low Income Population N/A
Completed NCT00044473 - A Study of the Effectiness and Safety of Levofloxacin in Treating Children With a Rapid and Severe Onset of Infection and Inflammation of the Middle Ear That is Difficult to Treat Phase 3
Completed NCT00781521 - Safety and Efficacy of Floxin Otic Solution in the Treatment of Acute Otitis Media in Children Phase 3