Evaluation of the Tympanostomy Tube Delivery System

NCT01202578 | Completed Phase 2 Results

• 1 other identifier: CPR005013
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to evaluate the performance and safety of the Tympanostomy Tube Delivery System (TTDS) for chronic otitis media or recurrent acute otitis media.

Conditions

Otitis Media With Effusion; Acute Otitis Media

Outcome Measures

Primary Outcomes (2)

• Safety of Tympanostomy Tube (TT) Delivery System

  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.

  7 days

• Device Success

  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.

  0 days

Secondary Outcomes (2)

• Proportion of Subjects With Procedure Success

  0 days

• Tube Retention

  7 days

Study Arms (1)

tympanostomy tube

EXPERIMENTAL

performance and safety of tympanostomy tube delivery system

Device: tympanostomy tube

Interventions

tympanostomy tube DEVICE

tympanostomy tube delivery system

tympanostomy tube

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosed with either chronic otitis media with effusion or acute otitis media and scheduled to undergo tympanostomy tube insertion

You may not qualify if:

• Reaction to anesthesia
• Markedly atrophic, bimeric, severely retracted, atelectatic or perforated tympanic membrane
• Otitis externa
• Active acute otitis media
• Otitis media pathology requiring T-tubes
• Stenosed ear canal
• Anatomy that precludes visualization and access to tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in posterior half of membrane

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (4)

South Coast ENT

Port Saint Lucie, Florida, 34952, United States

Location

Advanced ENT and Allergy

Louisville, Kentucky, 40207, United States

Location

Ear Medical Group

San Antonio, Texas, 78240, United States

Location

Evergreen Sinus Center

Kirkland, Washington, 98034, United States

Location

MeSH Terms

Conditions

Otitis Media with Effusion; Otitis Media

Interventions

Middle Ear Ventilation

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Ostomy; Surgical Procedures, Operative; Otologic Surgical Procedures; Otorhinolaryngologic Surgical Procedures

Results Point of Contact

• Title: Director of Clinical Research
• Organization: Acclarent, Inc.

lenglan1@its.jnj.com

650-687-5888

Study Officials

• Kenneth Faw, MD

  Evergreen Sinus Center

  PRINCIPAL INVESTIGATOR

• Andrew Gould, MD

  Advanced ENT and Allergy

  PRINCIPAL INVESTIGATOR

• Charles Syms, MD

  Ear Medical Group

  PRINCIPAL INVESTIGATOR

• Jacob Zeiders, MD

  South Coast ENT

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2010
• First Posted: September 16, 2010
• Study Start: September 1, 2010
• Primary Completion: November 1, 2010
• Study Completion: December 1, 2010
• Last Updated: August 6, 2024
• Results First Posted: July 11, 2014

Record last verified: 2024-07

Locations

US (4)