Hummingbird TTS Ear Tube Delivery Study

NCT02165384 | Completed Results

• 1 other identifier: Preceptis Alpha
• Study Type: interventional
• Target: 199
• Locations: 1 country
• Sites: 4

Brief Summary

The purpose of this study is to determine if the Hummingbird ear tube delivery system is a safe and effective way to put ear tubes in place.

Conditions

Otitis Media

Keywords

tympanostomy; myringotomy; otitis media; ear tubes; ear infection

Outcome Measures

Primary Outcomes (2)

• Percentage of Ears in Which an Ear Tube Was Successfully Delivered Across the Tympanic Membrane

  Success will be determined at the end of each ear tube procedure, by whether or not the TTS was used during the tympanostomy procedure to make an incision in the tympanic membrane and deploy an ear tube. Data may be presented when enrollment has been completed and all pre-operative and procedure data are analyzed.

  intra operative

• Number of Participants With Intra-operative Adverse Events

  Any intra-operative adverse events, anticipated or unanticipated

  Intra-operative

Study Arms (1)

Hummingbird TTS

EXPERIMENTAL

Ear tube placement with the Hummingbird TTS

Device: Ear tube placement with the Hummingbird TTS

Interventions

Ear tube placement with the Hummingbird TTS DEVICE

Using the Hummingbird TTS to make a myringotomy and deliver a tympanostomy tube across the tympanic membrane with one pass.

Also known as: Preceptis Medical, Inc. Tympanostomy Tube Introducer System, Hummingbird Tympanostomy Tube Delivery System, Hummingbird TTS

Hummingbird TTS

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.
• Subject is able and willing to comply with follow-up requirements.
• Signed Informed Consent, Parental Consent Form, or Child Assent Form as applicable.

You may not qualify if:

• Any condition that in the opinion of the investigator may place the subject at greater risk (e.g., pregnancy)
• Significantly atrophic tympanic membrane.
• Significantly atelectatic tympanic membrane. For example, the tympanic membrane is in contact with the promontory of the cochlea.
• Anatomy precludes sufficient visualization and access to the tympanic membrane.

Sponsors & Collaborators

• Preceptis Medical, Inc.: lead

Study Sites (4)

Fairview Maple Grove Surgery Center

Maple Grove, Minnesota, 55369, United States

Location

Children's Hospitals and Clinics of Minnesota

Minneapolis, Minnesota, 55404, United States

Location

University of Minnesota Masonic Children's Hospital

Minneapolis, Minnesota, 55454, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Otitis Media; Otitis

Condition Hierarchy (Ancestors)

Ear Diseases; Otorhinolaryngologic Diseases

Limitations and Caveats

Non-significant risk study. Treatment only evaluation of a surgical instrument used for tympanostomy procedures. Other instruments could be used during the tympanostomy procedure.

Results Point of Contact

• Title: CEO
• Organization: Preceptis Medical

steve@preceptismedical.com

6123274795

Study Officials

• Frank Rimell, MD

  Children's Hospitals and Clinics of Minnesota

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: June 12, 2014
• First Posted: June 17, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: January 3, 2019
• Results First Posted: January 3, 2019

Record last verified: 2018-12

Locations

US (4)