NCT01496287

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2011

Shorter than P25 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, 2011

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

December 16, 2011

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 21, 2011

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2012

Completed
2.3 years until next milestone

Results Posted

Study results publicly available

July 24, 2014

Completed
Last Updated

August 6, 2024

Status Verified

July 1, 2024

Enrollment Period

4 months

First QC Date

December 16, 2011

Results QC Date

June 26, 2014

Last Update Submit

July 10, 2024

Conditions

Otitis Media

Outcome Measures

Primary Outcomes (2)

  • Number of Participants With Procedural, Serious, and Device-Related Adverse Events

    Adverse events which are procedural, serious, and device-related.

    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.

    Day 0 (day of procedure)

Secondary Outcomes (3)

  • Procedure Success

    Day 0 (day of procedure)

  • Procedure Tolerability

    Day 0 (day of procedure)

  • Tube Retention

    2 weeks post procedure

Study Arms (1)

Tube placement group

EXPERIMENTAL
Device: Tube Delivery System (TDS)

Interventions

Tube Delivery System (TDS)DEVICE

Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system under local anesthesia in an office/clinic setting

Also known as: Tula TDS
Tube placement group

Eligibility Criteria

Age6 Months - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

South Coast Ear, Nose & Throat

Port Saint Lucie, Florida, 34952, United States

Location

Related Publications (2)

  • 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.

    PMID: 26611339DERIVED

  • 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.

    PMID: 26514928DERIVED

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Results Point of Contact

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

Study Officials

  • Jacob W Zeiders, M.D.

    South Coast Ear, Nose & Throat

    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

December 16, 2011

First Posted

December 21, 2011

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

April 1, 2012

Last Updated

August 6, 2024

Results First Posted

July 24, 2014

Record last verified: 2024-07

Locations

US(1)