Otitis MediaInovaNCT01496287

Tympanostomy Tube Placement in Children in the Office (Inova Study)

A study testing Tube Delivery System (TDS) in people with Otitis Media, run by Integra LifeSciences Corporation at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting. Read more about this study

Who is it for?: Ages 6 months to 21 years
Conditions the study is for: Otitis Media
What is being tested?: Tube Delivery System (TDS)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 70 participants
Where: 1 siteUnited States
Study dates: Dec 2011to Apr 2012
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 months to 21 years
All sexes
No healthy volunteers
Child, Adult

Who may be able to join

Scheduled to undergo tympanostomy tube insertion
At least 6 months old and younger than 22 years 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

South Coast Ear, Nose & Throat
Port Saint Lucie, Florida, 34952

Other trials in United States

About this study

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.

Conditions: Otitis Media
Being tested: Tube Delivery System (TDS)
Medical subject headings: Otitis Media

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Tube Delivery System (TDS)Device
Also called Tula TDS
Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting

Study groups in NCT01496287
Study group	Role	What they receive
Tube placement group	Experimental	Not described Receives: Device: Tube Delivery System (TDS)

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Procedural, Serious, and Device-Related Adverse Events
Adverse events which are procedural, serious, and device-related.
Measured: procedure up to 2 weeks post procedure
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.
Measured: Day 0 (day of procedure)

Secondary outcomes (3)

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.
Measured: Day 0 (day of procedure)
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.
"Tolerability" was defined as an average post-procedure pain score (of treated ears) <= "3"
Measured: Day 0 (day of procedure)
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.
Measured: 2 weeks post procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2011Apr 2012

First posted21 Dec 2011 (estimated)
Study startDec 2011
Primary completionApr 2012
Study completionApr 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Otitis MediaStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 70 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01496287
Sponsor's protocol ID: CPR005027
Acronym: Inova
Status last verified: Jul 2024
First submitted: 16 Dec 2011
Last updated: 6 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Zeiders JW, Syms CA, Mitskavich MT, Yen DM, Harfe DT, Shields RD, Lanier BJ, Gould AR, Mouzakes J, Elliott CL. Tympanostomy tube placement in awake, unrestrained pediatric patients: A prospective, multicenter study. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2416-23. doi: 10.1016/j.ijporl.2015.11.003. Epub 2015 Nov 10.
PubMed 26611339
Cohen LL, Martin SR, Gamwell KL, McCarty C, Shih SW. Behavioral techniques to optimize success of in-office pediatric tympanostomy tube placement without sedation. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2170-3. doi: 10.1016/j.ijporl.2015.09.041. Epub 2015 Oct 8.
PubMed 26514928

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

All Otitis Media trials

Study at a glance

From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Tympanostomy Tube Placement in Children in the Office (Inova Study)
ClinicalTrials.gov ID: NCT01496287
Acronym / sponsor ID: Inova / CPR005027
Conditions: Otitis Media
Study type: Interventional
Recruitment status: Completed
Enrolment: 70 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Collaborators: Acclarent
Study start: Dec 2011
Primary completion: Apr 2012 (actual)
Study completion: Apr 2012 (actual)
First posted: 21 Dec 2011 (estimated)
Results: Posted 24 Jul 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tula TDS for the placement of tympanostomy tubes under local anesthesia in an office/clinic setting.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Tube placement group	Experimental	Device: Tube Delivery System (TDS)

Who may qualify

Ages: 6 months to 21 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult

Key inclusion criteria (4 listed)

Scheduled to undergo tympanostomy tube insertion
At least 6 months old and younger than 22 years 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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Tube Delivery System (TDS)Also: Tula TDSPlacement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting	Device	Tube placement group

Primary outcome

Number of Participants With Procedural, Serious, and Device-Related Adverse Events
Time frame: procedure up to 2 weeks post procedure
Adverse events which are procedural, serious, and device-related.
Device Success
Time frame: Day 0 (day of procedure)
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.

3 secondary outcomes

Procedure Success
Time frame: Day 0 (day of procedure)
Procedure Tolerability
Time frame: Day 0 (day of procedure)
Tube Retention
Time frame: 2 weeks post procedure

Results and safety

Results posted to the registry on 24 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Tube Placement Group	70	64

Primary outcome: Number of Participants With Procedural, Serious, and Device-Related Adverse Events

Time frame: procedure up to 2 weeks post procedure. Number. Unit: participants

Measure	Tube Placement Group n = 70
Value	0

Primary outcome: Device Success

Time frame: Day 0 (day of procedure). Number. Unit: devices

Measure	Tube Placement Group n = 65
Value	114

Population analysed: Analysis population includes subjects who had completed the local anesthesia procedure (iontophoresis) and in which a TDS tube delivery device was attempted.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: procedure through 2 weeks post-procedure. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tube Placement Group	0 of 70 (0%)	3 of 70 (4.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26611339Zeiders JW, Syms CA, Mitskavich MT, Yen DM, Harfe DT, Shields RD, Lanier BJ, Gould AR, Mouzakes J, Elliott CL. Tympanostomy tube placement in awake, unrestrained pediatric patients: A prospective, multicenter study. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2416-23. doi: 10.1016/j.ijporl.2015.11.003. Epub 2015 Nov 10.
Derived from this study: PubMed 26514928Cohen LL, Martin SR, Gamwell KL, McCarty C, Shih SW. Behavioral techniques to optimize success of in-office pediatric tympanostomy tube placement without sedation. Int J Pediatr Otorhinolaryngol. 2015 Dec;79(12):2170-3. doi: 10.1016/j.ijporl.2015.09.041. Epub 2015 Oct 8.

Related trials for Otitis Media

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Nasopharyngeal Carriage of S. Pneumoniae
Nasopharyngeal Carriage, Children, Only
Recruiting
Platelet-Rich Fibrin in Revision Cartilage Tympanoplasty
Tympanic Membrane Perforation, Chronic Otitis Media

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Jacob W Zeiders, M.D. principal investigator

South Coast Ear, Nose & Throat

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Tube Delivery System (TDS) in people with Otitis Media, run by Integra LifeSciences Corporation at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Procedural, Serious, and Device-Related Adverse Events (time frame: procedure up to 2 weeks post procedure). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01496287, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2024.