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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

September 23, 2011
September 29, 2011
September 2011
March 2012   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01444391 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
inVENT-visIOn Study
A Clinical Study of the Acclarent Tympanostomy Tube Delivery and Iontophoresis Systems In-Office

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.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Otitis Media
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
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60
June 2012
March 2012   (final data collection date for primary outcome measure)

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
Both
6 Months and older
No
Contact: Robert K Sink 650-687-4820 rsink@its.jnj.com
Contact: Patricia Chen 650-687-4451 pchen126@its.jnj.com
United States
 
NCT01444391
CPR005022
No
Acclarent
Acclarent
Not Provided
Principal Investigator: Jacob W. Zeiders, M.D. South Coast Ear, Nose & Throat
Acclarent
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP