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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.
The objective of this study is to evaluate the safety and performance of the TTI device for the placement of ear tubes in patients undergoing a tympanostomy tube placement procedure.The trial will be a multi-site, prospective, treatment only study of the Preceptis ear tube introducer . Patients will already have a scheduled tympanostomy procedure. Enrollment in the study at each site will begin after receipt of Institutional Review Board (IRB) approval. Patients will be considered enrolled at the time the informed consent document is signed. A maximum of two hundred fifty (250) subjects will be included in the study at up to 5 sites.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hummingbird TTS | Experimental | Ear tube placement with the Hummingbird TTS |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Frank Rimell, MD | Children's Hospitals and Clinics of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fairview Maple Grove Surgery Center | Maple Grove | Minnesota | 55369 | United States | ||
| Children's Hospitals and Clinics of Minnesota |
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| ID | Title | Description |
|---|---|---|
| FG000 | Hummingbird TTS | Treatment only surgical instrument study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Patients scheduled for tympanostomy tube insertion that are at least 6 months old
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| ID | Title | Description |
|---|---|---|
| BG000 | Hummingbird TTS | Treatment only surgical instrument study |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 393 ears in 199 patients received ear tube placement from the Hummingbird device. | Posted | Count of Units | Ears | intra operative | Ears | Ears |
|
Intra-operative
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Hummingbird TTS | Treatment only HTTS was used to make incision and deliver ear tube |
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Non-significant risk study. Treatment only evaluation of a surgical instrument used for tympanostomy procedures.
Other instruments could be used during the tympanostomy procedure.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| CEO | Preceptis Medical | 6123274795 | steve@preceptismedical.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 30, 2013 | Nov 16, 2018 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D010033 | Otitis Media |
| D010031 | Otitis |
| ID | Term |
|---|---|
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
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|
| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| University of Minnesota Masonic Children's Hospital | Minneapolis | Minnesota | 55454 | United States |
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| months |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race not captured | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
| Ears |
|
|
| Primary | Number of Participants With Intra-operative Adverse Events | Any intra-operative adverse events, anticipated or unanticipated | Posted | Count of Participants | Participants | Intra-operative |
|
|
|
| 0 |
| 199 |
| 0 |
| 199 |
| 0 |
| 199 |
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