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inVENT-visIOn Study

This study is currently recruiting participants.
Verified September 2011 by Acclarent
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01444391
First received: September 23, 2011
Last updated: September 29, 2011
Last verified: September 2011
History of Changes
  Purpose

The objective of the study is to evaluate the safety and efficacy of the Acclarent TTDS for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.


Condition Intervention
Otitis Media
 Device: Tympanostomy tube placement (Acclarent iontophoresis device)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Safety [ Time Frame: 2 weeks ] [ Designated as safety issue: Yes ]
    Those adverse events which are procedural, serious, and device-related.

  • Effectiveness [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    The successful delivery of the tympanostomy tube across the tympanic membrane.


Secondary Outcome Measures:
  • Procedure Success [ Time Frame: Day 0 ] [ Designated as safety issue: Yes ]
    Successful placement of any tympanostomy tube, with no safety events.

  • Tube Placement Tolerability [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Subject reporting of level of discomfort.

  • Iontophoresis tolerability [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Subject reporting of level of discomfort.

  • Tube Retention [ Time Frame: Day 0 ] [ Designated as safety issue: No ]
    Presence of the tympanostomy tube across the tympanic membrane at the follow-up visit.


Estimated Enrollment: 60
Study Start Date: September 2011
Estimated Study Completion Date: June 2012
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Device: Tympanostomy tube placement (Acclarent iontophoresis device)
    Placement of tympanostomy tube by the Acclarent tympanostomy tube delivery system following delivery of anesthetic with Acclarent iontophoresis device
  Eligibility

Ages Eligible for Study:   6 Months and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01444391

Contacts
Contact: Robert K Sink 650-687-4820 rsink@its.jnj.com
Contact: Patricia Chen 650-687-4451 pchen126@its.jnj.com

Locations
United States, Florida
South Coast Ear, Nose, & Throat Recruiting
Port St. Lucie, Florida, United States, 34952
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Jacob W. Zeiders, M.D. South Coast Ear, Nose & Throat
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01444391     History of Changes
Other Study ID Numbers: CPR005022
Study First Received: September 23, 2011
Last Updated: September 29, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Acclarent:
Tympanostomy tube placement
iontophoresis

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases

ClinicalTrials.gov processed this record on June 17, 2013