inVENT-visIOn Study

NCT01444391 | Completed Results

• 1 other identifier: CPR005022
• Study Type: interventional
• Target: 42
• 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 (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.

Conditions

Otitis Media

Keywords

Tympanostomy tube placement; iontophoresis

Outcome Measures

Primary Outcomes (2)

• Number of Subjects With Procedural, Serious and Device-related Adverse Events.

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

  Procedure through 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)

Tympanostomy Tube Placement

EXPERIMENTAL

Device: Tympanostomy tube placement (Acclarent iontophoresis device)

Interventions

Tympanostomy tube placement (Acclarent iontophoresis device) DEVICE

Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device

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)
• 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

Sponsors & Collaborators

• Integra LifeSciences Corporation: lead
• Acclarent: collaborator

Study Sites (1)

South Coast Ear, Nose, & Throat

Port Saint Lucie, Florida, 34952, United States

Location

MeSH Terms

Conditions

Otitis Media

Condition Hierarchy (Ancestors)

Otitis; Ear Diseases; Otorhinolaryngologic Diseases

Results Point of Contact

• Title: Director Clinical
• Organization: Acclarent

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: September 23, 2011
• First Posted: September 30, 2011
• Study Start: October 1, 2011
• Primary Completion: May 1, 2012
• Study Completion: June 1, 2012
• Last Updated: July 12, 2024
• Results First Posted: September 19, 2014

Record last verified: 2024-07

Locations

US (1)