inVENT-In-Office Study

NCT01324271 | Completed Results

• 1 other identifier: CPR005016
• Study Type: interventional
• Target: 85
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.

Conditions

Otitis Media

Keywords

Tympanostomy tube placement

Outcome Measures

Primary Outcomes (2)

• Percentage of Subjects With In-office Tube Placement 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: the rate was calculated based on the number of subjects achieving Procedure Success out of the total number of enrolled subjects. Only subjects for whom tubes were placed under local anesthesia were evaluated for Procedure Success.

  Day 0

• Percentage of Tubes Successfully Placed Using a TTDS Device

  Device (TTDS) success is defined as the successful delivery of a pre-loaded TT tube across the tympanic membrane using the TTDS. Device success will be evaluated per device attempted. Office/clinical subjects only. A Device (Type of Unit analyzed) is defined as a TDS attempt. This is not synonymous with "tube." Tube is the outcome of the device use.

  Day 0

Secondary Outcomes (1)

• Number of Retained (TTDS-placed) Tubes

  14 days

Study Arms (1)

Tympanostomy tube placement

EXPERIMENTAL

placement of tympanostomy tube under local anesthesia in office/clinic setting

Device: Acclarent Tympanostomy Tube Delivery system (TTDS)

Interventions

Acclarent Tympanostomy Tube Delivery system (TTDS) DEVICE

placement of tympanostomy tube under local anesthesia

Also known as: Tula™

Tympanostomy tube placement

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:

• Scheduled to undergo tympanostomy tube insertion
• At least 6 months old
• Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)

You may not qualify if:

• History of sensitivity or reaction to anesthesia chosen for the procedure
• Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
• Otitis externa
• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (1)

Unknown Facility

San Antonio, Texas, 78240, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

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

lenglan1@its.jnj.com

650-687-5888

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: March 23, 2011
• First Posted: March 29, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: May 1, 2012
• Last Updated: August 6, 2024
• Results First Posted: November 25, 2014

Record last verified: 2024-07

Locations

US (1)