NCT01046877

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

January 11, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 12, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
3.5 years until next milestone

Results Posted

Study results publicly available

November 18, 2014

Completed
Last Updated

August 6, 2024

Status Verified

July 1, 2024

Enrollment Period

1.7 years

First QC Date

January 11, 2010

Results QC Date

November 12, 2014

Last Update Submit

July 10, 2024

Conditions

Otitis Media

Outcome Measures

Primary Outcomes (1)

  • 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.

    Procedural

Secondary Outcomes (10)

  • Percentage of Tympanostomy Tubes Extruded at 12 Months Post Procedure

    12 months

  • Percentage of Patent Tubes

    30 days

  • Percentage of Patent Tubes

    3 months

  • Percentage of Patent Tubes

    6 months

  • Percentage of Patent Tubes

    9 Months

  • +5 more secondary outcomes

Study Arms (1)

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).

Device: Tympanostomy Tube Delivery System

Interventions

Tympanostomy Tube Delivery SystemDEVICE

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

Also known as: Acclarent Tympanostomy Tube Delivery System
Tympanostomy Tube placement

Eligibility Criteria

Age1 Year+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • \>= 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 -

You may not qualify if:

  • 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 -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

KK Women's and Children's Hospital Singapore

Singapore, Singapore

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Limitations and Caveats

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.

Results Point of Contact

Title
Director of Clinical Research
Organization
Acclarent
lenglan1@its.jnj.com
650-687-5888

Study Officials

  • Henry Tan, MD

    KK Women's and Children's Hospital, Singapore

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
GT60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2010

First Posted

January 12, 2010

Study Start

December 1, 2008

Primary Completion

August 1, 2010

Study Completion

June 1, 2011

Last Updated

August 6, 2024

Results First Posted

November 18, 2014

Record last verified: 2024-07

Locations

SG(1)