Singapore Tympanostomy Tube Delivery System Study

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Acclarent
ClinicalTrials.gov Identifier:
NCT01046877
First received: January 11, 2010
Last updated: March 14, 2014
Last verified: March 2014
  Purpose

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes (TTs) in patients indicated for such treatment for chronic otitis media with effusion (OME) or recurrent acute otitis media (AOM).


Condition Intervention
Otitis Media
Device: Tympanostomy Tube Delivery System

Study Type: Interventional
Study Design: 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 System For The Treatment of Patients Requiring Tympanostomy Tube Insertion For Otitis Media

Resource links provided by NLM:


Further study details as provided by Acclarent:

Primary Outcome Measures:
  • Acute Procedural Success: Absence of acute intraprocedural adverse events and device success. [ Time Frame: Procedural ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Rate of TT extrusion at 12 months [ Time Frame: 12 months ] [ Designated as safety issue: No ]
  • Rate of tube patency [ Time Frame: at 30 days, and 3, 6, 9, and 12 months ] [ Designated as safety issue: No ]
  • Incidence of adverse events [ Time Frame: at 30 days, 3, 6, 9, and 12 months ] [ Designated as safety issue: Yes ]

Enrollment: 25
Study Start Date: May 2009
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Tympanic Tube placement
Tympanostomy Tube Delivery System (TTDS) in the placement of tympanostomy tubes in patients indicated for such treatment for chronic Otitis Media with Effusion (OME) or recurrent Acute Otitis Media(AOM).
Device: Tympanostomy Tube Delivery System
Placement of the Tympanostomy Tube by the Acclarent Tympanostomy Tube Delivery System (TTDS)
Other Name: Acclarent Tympanostomy Tube Delivery System

  Eligibility

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. >= 1 year of age
  2. Diagnosed with either Chronic OME or recurrent Acute Otitis Media and scheduled to undergo bilateral or unilateral tympanostomy tube insertion.
  3. Either male or female -

Exclusion Criteria:

  1. History of sensitivity or reaction to anaesthesia
  2. Markedly atrophic, retracted, atelectatic or perforated tympanic membrane.
  3. Otitis externa
  4. Active acute otitis media
  5. Thickened Tympanic Membrane
  6. Thick mucoid effusion (also known as "glue ear")
  7. Otitis media pathology requiring T-tubes -
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01046877

Locations
Singapore
KK Women's and Children's Hospital Singapore
Singapore, Singapore
Sponsors and Collaborators
Acclarent
Investigators
Principal Investigator: Henry Tan, MD KK Women's and Children's Hospital Singapore
  More Information

No publications provided

Responsible Party: Acclarent
ClinicalTrials.gov Identifier: NCT01046877     History of Changes
Other Study ID Numbers: CPR005004
Study First Received: January 11, 2010
Last Updated: March 14, 2014
Health Authority: Singapore: Health Sciences Authority

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

ClinicalTrials.gov processed this record on August 20, 2014