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Evaluation of the Tympanostomy Tube Delivery System (inVENT-OR)

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ClinicalTrials.gov Identifier: NCT01202578
Recruitment Status : Completed
First Posted : September 16, 2010
Results First Posted : July 11, 2014
Last Update Posted : July 11, 2014
Sponsor:
Information provided by (Responsible Party):
Acclarent

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Otitis Media With Effusion
Acute Otitis Media
Intervention Device: tympanostomy tube
Enrollment 53

Recruitment Details Eligible subjects presenting to the clinical study site for whom tympanostomy tube insertion was recommended were offered the opportunity to participate in the study by study investigators.
Pre-assignment Details  
Arm/Group Title Tympanostomy Tube Placement Using the Tube Delivery System
Hide Arm/Group Description [Not Specified]
Period Title: Overall Study
Started 53
Completed 53
Not Completed 0
Arm/Group Title Tympanostomy Tube Placement Using the Tube Delivery System
Hide Arm/Group Description [Not Specified]
Overall Number of Baseline Participants 53
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 53 participants
2.68  (2.49)
Age, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 53 participants
<=5 years 47
>5 years 6
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 53 participants
Female
22
  41.5%
Male
31
  58.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 53 participants
53
1.Primary Outcome
Title Safety of Tympanostomy Tube (TT) Delivery System
Hide Description Occurrence of pre-defined Safety Events of acoustic trauma, deployment of the TT into the middle ear, damage to middle ear structures, unintended tympanic membrane perforation requiring treatment, abrasion to the external acoustic meatus requiring significant treatment, and major bleeding requiring significant treatment.
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Subjects in whom TTDS was attempted.
Arm/Group Title Tympanostomy Tube Placement Using the Tube Delivery System
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 53
Overall Number of Units Analyzed
Type of Units Analyzed: Ears
101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of ears
0.0
(0.0 to 3.6)
2.Primary Outcome
Title Device Success
Hide Description Device Success is defined as the successful delivery of the tympanostomy tube across the tympanic membrane using the tympanostomy tube delivery system (TTDS).Device Success is evaluated on a per device basis.
Time Frame 0 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Device Success is evaluated on a per device basis.
Arm/Group Title Tympanostomy Tube Placement Using the Tube Delivery System
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 53
Overall Number of Units Analyzed
Type of Units Analyzed: Devices
101
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of devices
94.1
(87.5 to 97.8)
3.Secondary Outcome
Title Proportion of Subjects With Procedure Success
Hide Description Procedure Success was defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Non-Acclarent tubes successfully placed manually following non-success of the TTDS were counted toward Procedure Success. Procedure Success was determined on a per subject basis: the rate was calculated by the number of subjects achieving Procedure Success out of the total number of enrolled subjects.
Time Frame 0 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Tympanostomy Tube Placement Using the Tube Delivery System
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 53
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
100
(93.3 to 100.0)
4.Secondary Outcome
Title Tube Retention
Hide Description Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Tube retention was assessed for all TT successfully placed by the TTDS
Arm/Group Title Tympanostomy Tube Placement Using the Tube Delivery System
Hide Arm/Group Description:
[Not Specified]
Overall Number of Participants Analyzed 53
Overall Number of Units Analyzed
Type of Units Analyzed: Tympanostomy tubes placed by TTDS
95
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of tubes retained
99.0
(94.3 to 100.0)
Time Frame 7 days
Adverse Event Reporting Description Adverse events occured only in study cohort (non lead-in) participants.
 
Arm/Group Title Safety Events
Hide Arm/Group Description Safety in terms of number affected subjects in total number of subjects.
All-Cause Mortality
Safety Events
Affected / at Risk (%)
Total   --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Safety Events
Affected / at Risk (%) # Events
Total   0/53 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Safety Events
Affected / at Risk (%) # Events
Total   4/53 (7.55%)    
Ear and labyrinth disorders   
Tube Lumen Occlusion   4/53 (7.55%)  5
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Director of Clinical Research
Organization: Acclarent, Inc.
Phone: 650-687-5888
Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01202578     History of Changes
Other Study ID Numbers: CPR005013
First Submitted: September 13, 2010
First Posted: September 16, 2010
Results First Submitted: May 7, 2014
Results First Posted: July 11, 2014
Last Update Posted: July 11, 2014