Otitis MediaNCT01046877

Singapore Tympanostomy Tube Delivery System Study

A study testing Tympanostomy Tube Delivery System in people with Otitis Media, run by Integra LifeSciences Corporation at 1 site in Singapore.

Completed

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

Official record

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Trial summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM). Read more about this study

Who is it for?: Ages 1 year and older
Conditions the study is for: Otitis Media
What is being tested?: Tympanostomy Tube Delivery System
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 25 participants
Where: 1 siteSingapore
Study dates: Dec 2008to Jun 2011
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 1 year and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

>= 1 year of age
Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
Either male or female -

Who cannot join

History of sensitivity or reaction to anaesthesia
Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
Otitis externa
Active acute otitis media
Thickened Tympanic Membrane
Thick mucoid effusion (also known as "glue ear")
Otitis media pathology requiring T-tubes -

Trial locations and contacts

1 site in 1 country.

Singapore1 site

KK Women's and Children's Hospital Singapore
Singapore

Other trials in Singapore

About this study

Official title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For The Treatment of Patients Requiring Tympanostomy Tube Insertion For Otitis Media

Conditions: Otitis Media
Being tested: Tympanostomy Tube Delivery System
Medical subject headings: Otitis Media

What participants receive

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

Tympanostomy Tube Delivery SystemDevice
Also called Acclarent Tympanostomy Tube Delivery System
Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)

Study groups in NCT01046877
Study group	Role	What they receive
Tympanostomy Tube placement	Experimental	Tympanostomy Tube Delivery System (TTDS) used for placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM). Receives: Device: Tympanostomy Tube Delivery System

What is being measured

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

Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.
TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.
Measured: Procedural

Secondary outcomes (10)

Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure
Measured: 12 months
Percentage of Patent Tubes
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Measured: 30 days
Percentage of Patent Tubes
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Measured: 3 months
Percentage of Patent Tubes
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Measured: 6 months
Percentage of Patent Tubes
This measure assesses the patency (openness or lack of obstruction) of unextruded tubes.
Measured: 9 Months
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Measured: 30 days
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Measured: 3 months
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Measured: 6 months
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Measured: 9 months
Percentage of Ears With Adverse Events
This outcome measure evaluates occurrence of new adverse events since prior follow-up visit. (non-cumulative)
Measured: 12 months post procedure

Timeline

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

Dec 2008Jun 2011

First posted12 Jan 2010 (estimated)
Study startDec 2008
Primary completionAug 2010
Study completionJun 2011

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.
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: 25 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01046877
Sponsor's protocol ID: CPR005004
Status last verified: Jul 2024
First submitted: 11 Jan 2010
Last updated: 6 Aug 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
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: A Clinical Study of the Acclarent Tympanostomy Tube Delivery System For The Treatment of Patients Requiring Tympanostomy Tube Insertion For Otitis Media
ClinicalTrials.gov ID: NCT01046877
Acronym / sponsor ID: CPR005004
Conditions: Otitis Media
Study type: Interventional
Recruitment status: Completed
Enrolment: 25 participants (actual)
Lead sponsor: Integra LifeSciences CorporationIndustry (pharma, biotech, devices)
Collaborators: Acclarent
Study start: Dec 2008
Primary completion: Aug 2010 (actual)
Study completion: Jun 2011 (actual)
First posted: 12 Jan 2010 (estimated)
Results: Posted 18 Nov 2014

Clinical summary

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

Study design

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

Arm	Type	Receives
Tympanostomy Tube placement	Experimental	Device: Tympanostomy Tube Delivery SystemTympanostomy Tube Delivery System (TTDS) used for placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

>= 1 year of age
Diagnosed with either Chronic Otitis Media with Effusion or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
Either male or female -

Key exclusion criteria (7 listed)

History of sensitivity or reaction to anaesthesia
Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
Otitis externa
Active acute otitis media
Thickened 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
Tympanostomy Tube Delivery SystemAlso: Acclarent Tympanostomy Tube Delivery SystemPlacement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)	Device	Tympanostomy Tube placement

Primary outcome

Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.
Time frame: Procedural
TTDS success will be confirmed by the successful delivery of a tube to the tympanic membrane.

10 secondary outcomes

Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure
Time frame: 12 months
Percentage of Patent Tubes
Time frame: 30 days
Percentage of Patent Tubes
Time frame: 3 months
Percentage of Patent Tubes
Time frame: 6 months
Percentage of Patent Tubes
Time frame: 9 Months
Percentage of Ears With Adverse Events
Time frame: 30 days
Percentage of Ears With Adverse Events
Time frame: 3 months
Percentage of Ears With Adverse Events
Time frame: 6 months
Percentage of Ears With Adverse Events
Time frame: 9 months
Percentage of Ears With Adverse Events
Time frame: 12 months post procedure

Results and safety

Results posted to the registry on 18 Nov 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
Tympanic Tube Placement	25	7

Primary outcome: Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events.

Time frame: Procedural. Number (95% Confidence Interval). Unit: percentage of ears

Measure	Tympanic Tube Placement n = 24
Value	94.6 (81.8 to 99.3)

Population analysed: One subject was missing data on intraprocedural adverse events and is excluded from this analysis.

10 secondary outcomes are reported in the full results.

Adverse events

Time frame: Final follow-up visit was the earlier of 24 months post-procedure or 12 months after tube extrusion.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Tympanic Tube Placement	0 of 25 (0%)	1 of 25 (4%)	Not reported

Limitations and caveats (from the sponsor): The protocol called for outcome measure assessing patency (openness/lack of obstruction) of unextruded tubes at 12 mos post procedure. Since all tubes had already been extruded by 12 mos, no ears with tubes remained for assessment and it was omitted.

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.

Related trials for Otitis Media

Active, not recruiting
In-Office Clinical Study of the Solo+ TTD
Ear Infection, Otitis Media
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
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.

Henry Tan, MD principal investigator

KK Women's and Children's Hospital

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

Questions about this trial

What is this clinical trial studying?

A study testing Tympanostomy Tube Delivery System in people with Otitis Media, run by Integra LifeSciences Corporation at 1 site in Singapore.

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 3 inclusion and 7 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 Singapore. 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 18 Nov 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?

Percentage of Ears Treated Successfully With the TTDS in the Absence of Acute Intraprocedural Adverse Events. (time frame: Procedural). 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 NCT01046877.

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.