OME - Otitis Media With EffusionPhase 3OTTERNCT03323736
In-Office Tympanostomy Tube Placement in Children (OTTER)
A Phase 3 study testing Iontophoresis & tube placement and Tube placement in people with OME - Otitis Media With Effusion and AOM - Acute Otitis Media, run by Tusker Medical at 19 sites in 2 countries.
Trial summary
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting. Read more about this study
- Who is it for?
- Ages 6 months to 12 years
- Conditions the study is for
- OME - Otitis Media With Effusion, AOM - Acute Otitis Media
- What is being tested?
- Iontophoresis & tube placement and Tube placement
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 370 participants
- Where
- 19 sitesin 2 countries
- Study dates
- 31 Oct 2017to 25 Mar 2021
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 months to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Males or females at least 6 months old through 12 years old at time of consent
- Indication for tympanostomy tube insertion per Clinical Practice Guideline
- Behavioral capacity and cooperative temperament to undergo an awake procedure, based on physician judgment (not applicable to OR Lead-In subjects)
- Subject's parent/guardian and subject are able and willing to comply with the protocol and attend all study visits
- Subject's parent/guardian and subject are able and willing to provide informed consent or assent as age appropriate
Who cannot join
- Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
- Perforated tympanic membrane
- Otitis externa
- Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
- Hemotympanum
- Damaged/denuded skin in the auditory canal
Show all 15Show fewer
- Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane potentially causing abrasion or irritation to the external ear canal
- 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
- History of sensitivity or allergic reaction to lidocaine HCl, tetracaine, epinephrine, or any hypersensitivity to local anesthetics of the amide type, or any component of the anesthetic drug formulation (not applicable to OR Lead-In subjects)
- Familial history of insensitivity to lidocaine or other local anesthetics of the amide type (eg, history of inadequate anesthesia with dental numbing agents). (not applicable to OR Lead-In subjects)
- Electrically sensitive medical support systems (eg, pacemakers, defibrillators, cochlear implants)
- Other conditions that would preclude performing the study procedure including iontophoresis system ear plug incompatibility.
- Health conditions that, in the opinion of the investigator, would present undue risk to the subject, based on device/anesthetic drug product label warnings and precautions.
- Subject is 4 years or older and not able to complete all baseline assessments. Subject is younger than 4 years and not able to complete all baseline assessments, not including audiometry.
Trial locations and contacts
19 sites in 2 countries.
19 sites in 2 countries
United States18 sites
Ear Nose and Throat Specialists of Abilene
Abilene, Texas, 79601
Albany ENT & Allergy Services
Albany, New York, 12206
Specialty Physician Associates
Bethlehem, Pennsylvania, 18017
California Head and Neck Specialists
Carlsbad, California, 92008
Charlotte Ear Eye Nose & Throat Associates, PA
Charlotte, North Carolina, 28105
South Florida Pediatric Otolaryngology
Fort Lauderdale, Florida, 33316
Frisco ENT for Children
Frisco, Texas, 75033
Collin County ENT
Frisco, Texas, 75034
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Nemour's Children's Specialty Care
Jacksonville, Florida, 32207
Advanced ENT & Allergy
Louisville, Kentucky, 40207
South Carolina Ear Nose and Throat
Lugoff, South Carolina, 29078
Yale School of Medicine, Section of Otolaryngology
New Haven, Connecticut, 06510
Columbia University Medical Center
New York, New York, 10032
Carolina Ear Nose and Throat Clinic
Orangeburg, South Carolina, 29118
Sacramento ENT
Roseville, California, 95661
Ear Medical Group
San Antonio, Texas, 78240
Camino Ear Nose & Throat Clinic
San Jose, California, 95138
Canada1 site
British Columbia Children's Hospital
Vancouver, British Columbia, V6H 3N1
About this study
Official title: A Prospective, Single-arm, Multicenter Study to Evaluate Effectiveness and Safety of Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Children in an Office Setting.
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
Read the detailed description
The objective of this study is to evaluate effectiveness and safety of tympanostomy tube (TT) placement in children following local anesthesia in a physician's clinic setting (henceforth referred to as 'in-office'). Local anesthesia using Tymbion, a lidocaine-based anesthetic, is delivered by the Tula Iontophoresis System (IPS) and TT placement is implemented by the Tula Tube Delivery System (TDS).
The IPS will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The Iontophoresis System consists of an Iontophoresis Control Unit, Iontophoresis Earsets and a return electrode patch. The Control Unit monitors and delivers a fixed amount of charge (ie, dose) to the patient through the Earsets(s) and alerts the operator when charge delivery is complete. The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).
The TDS is a mechanical device that integrates a myringotomy blade, tympanostomy tube and tube inserter for TT placement with a user-controlled activation. The study will use the TDS with a grommet-type tube.
This pivotal study will include up to 422 children ages 6 months through 12 years indicated for tympanostomy tube placement enrolled at approximately 15 to 25 investigational centers in the US and Canada. The pivotal cohort consists of 222 subjects. In addition, up to 100 subjects will be enrolled as lead-in procedures in the OR using the TDS and up to 100 subjects will be enrolled as lead-in procedure in-office (using IPS and TDS) as the surgeons' initial experience with the technology prior to enrolling into the pivotal cohort.
All pivotal and lead-in subjects will follow the same study protocol assessments and visit schedule consisting of a screening visit, procedure visit and 3-week, 6 month, 12 month, 18 month, and 24 month post-procedure follow-up visits. Lead-in procedures will be analyzed separately from the pivotal pediatric cohort.
- Being tested
- Iontophoresis & tube placement, Tube placement
- Medical subject headings
- Otitis Media with Effusion, Otitis Media
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iontophoresis & tube placementCombination product
Subjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement.
Tube placementDevice
Subjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement.
| Study group | Role | What they receive |
|---|---|---|
| Pivotal Cohort | Other | Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office. Receives: Combination Product: Iontophoresis & tube placement |
| Office Lead-In Cohort | Other | Active Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office. Physician initial in-office iontophoresis and tube insertion procedures (minimum of 2 subjects per investigator). Receives: Combination Product: Iontophoresis & tube placement |
| OR Lead-In Cohort | Other | Tubes insertion using the Tube Delivery System in the operating room (OR). Physician initial tube insertion procedures in the OR (minimum of 2 subjects per investigator). Receives: Device: Tube placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedural Success:
Count (and percentage) of subjects in the pivotal cohort with successful placement of Tusker Medical tympanostomy tubes in all indicated ears in an office procedure. Note: the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Measured: Day of Procedure (Day 0) Immediately following tube placement
Tube Placement Tolerability
Mean subject-reported pain score following TDS tube placement using the Faces Pain Scale-Revised (FPS-R) (pivotal cohort children ages 5 and older only). The FPS-R has 6 faces which permits scaling to a 0-to-10 scoring system in intervals of 2 (ie 0, 2, 4, 6, 8 and 10), where 0 represents 'no pain' and 10 represents 'very much pain'. Note- the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Measured: Day of Procedure (Day 0) Immediately following tube placement
Secondary outcomes (3)
Tube Patency
Count (and percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube was successfully placed, with functionally patent tube(s) at the 3-week post-procedure follow-up visit.
Note- thus secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Patency endpoint for the ear that was successful.
Measured: 3 Weeks Post Procedure
Tube Retention
Count (percentage) of subjects in the pivotal cohort, in which a Tusker Medical tube(s) was successfully placed, with presence of a Tusker Medical tube across the TM in all successfully treated ears at the 3-week post-procedure follow-up visit.
Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Note - This endpoint includes subjects for which at least 1 ear had successful tube placement. For bilateral subjects, they may be considered a non-successful procedure if only 1 ear had successful tube placement, however would be evaluated for the Tube Retention endpoint for the ear that was successful.
Measured: 3 Weeks Post Procedure
Anesthesia Effectiveness
Count (percentage) of subjects in the pivotal cohort, who completed iontophoresis for all indicated ears, with adequate anesthesia for TT placement in all treated ears as determined by physician's evaluation of TM anesthesia prior to tube placement.
Note- the secondary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Measured: Day of Procedure (Day 0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2017
- Study start31 Oct 2017
- Primary completion28 Feb 2019
- Study completion25 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OME - Otitis Media With EffusionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Model description
- Pivotal cohort is single arm. Physician initial subjects evaluated in separate cohorts but not included in primary and secondary analyses.
- Masking
- None (open label)
- Enrolment
- 370 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tusker Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lawrence Lustig, Principal investigator, Columbia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03323736
- Sponsor's protocol ID
- CPR007001
- Acronym
- OTTER
- Status last verified
- May 2022
- First submitted
- 24 Oct 2017
- Last updated
- 26 May 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single-arm, Multicenter Study to Evaluate Effectiveness and Safety of Tympanostomy Tube Placement Using the Tula Iontophoresis and Tube Delivery Systems for Children in an Office Setting.
- ClinicalTrials.gov ID
- NCT03323736
- Acronym / sponsor ID
- OTTER / CPR007001
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 370 participants (actual)
- Lead sponsor
- Tusker MedicalIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2017 (actual)
- Primary completion
- 28 Feb 2019 (actual)
- Study completion
- 25 Mar 2021 (actual)
- First posted
- 27 Oct 2017 (actual)
- Results
- Posted 31 Jan 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective, single-arm, multicenter study to evaluate effectiveness and safety of Tymbion iontophoresis and tympanostomy tube placement using the Tula Iontophoresis and Tube Delivery Systems for children in an office setting.
Detailed description
The objective of this study is to evaluate effectiveness and safety of tympanostomy tube (TT) placement in children following local anesthesia in a physician's clinic setting (henceforth referred to as 'in-office'). Local anesthesia using Tymbion, a lidocaine-based anesthetic, is delivered by the Tula Iontophoresis System (IPS) and TT placement is implemented by the Tula Tube Delivery System (TDS).
The IPS will be used to facilitate anesthetic delivery to the tympanic membrane (TM). The Iontophoresis System consists of an Iontophoresis Control Unit, Iontophoresis Earsets and a return electrode patch. The Control Unit monitors and delivers a fixed amount of charge (ie, dose) to the patient through the Earsets(s) and alerts the operator when charge delivery is complete. The lidocaine-based solution used for local anesthesia of the TM is Tymbion (2% lidocaine HCl/ 1:100,000 epinephrine).
The TDS is a mechanical device that integrates a myringotomy blade, tympanostomy tube and tube inserter for TT placement with a user-controlled activation. The study will use the TDS with a grommet-type tube.
This pivotal study will include up to 422 children ages 6 months through 12 years indicated for tympanostomy tube placement enrolled at approximately 15 to 25 investigational centers in the US and Canada. The pivotal cohort consists of 222 subjects. In addition, up to 100 subjects will be enrolled as lead-in procedures in the OR using the TDS and up to 100 subjects will be enrolled as lead-in procedure in-office (using IPS and TDS) as the surgeons' initial experience with the technology prior to enrolling into the pivotal cohort.
All pivotal and lead-in subjects will follow the same study protocol assessments and visit schedule consisting of a screening visit, procedure visit and 3-week, 6 month, 12 month, 18 month, and 24 month post-procedure follow-up visits. Lead-in procedures will be analyzed separately from the pivotal pediatric cohort.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Pivotal cohort is single arm. Physician initial subjects evaluated in separate cohorts but not included in primary and secondary analyses.
| Arm | Type | Receives |
|---|---|---|
| Pivotal Cohort | Other | Combination Product: Iontophoresis & tube placementActive Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office. |
| Office Lead-In Cohort | Other | Combination Product: Iontophoresis & tube placementActive Tymbion iontophoresis and tube insertion using the Tube Delivery System in-office. Physician initial in-office iontophoresis and tube insertion procedures (minimum of 2 subjects per investigator). |
| OR Lead-In Cohort | Other | Device: Tube placementTubes insertion using the Tube Delivery System in the operating room (OR). Physician initial tube insertion procedures in the OR (minimum of 2 subjects per investigator). |
Who may qualify
- Ages
- 6 months to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Males or females at least 6 months old through 12 years old at time of consent
- Indication for tympanostomy tube insertion per Clinical Practice Guideline
- Behavioral capacity and cooperative temperament to undergo an awake procedure, based on physician judgment (not applicable to OR Lead-In subjects)
- Subject's parent/guardian and subject are able and willing to comply with the protocol and attend all study visits
- Subject's parent/guardian and subject are able and willing to provide informed consent or assent as age appropriate
Key exclusion criteria (15 listed)
- Significantly atrophic, retracted, bimeric, monomeric or atelectatic tympanic membrane
- Perforated tympanic membrane
- Otitis externa
- Active or recent conditions of the tympanic membrane (eg, prior myringotomy with incomplete wound healing or re-epithelization)
- Hemotympanum
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iontophoresis & tube placementSubjects will receive active Tymbion iontophoresis and will have tubes placed in-office using the Tube Delivery System in all ears indicated for tube placement. | Combination product | Office Lead-In Cohort, Pivotal Cohort |
| Tube placementSubjects will have tubes placed in the OR using the Tube Delivery System in all ears indicated for tube placement. | Device | OR Lead-In Cohort |
Primary outcome
Procedural Success:
Time frame: Day of Procedure (Day 0) Immediately following tube placement
Count (and percentage) of subjects in the pivotal cohort with successful placement of Tusker Medical tympanostomy tubes in all indicated ears in an office procedure. Note: the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
Tube Placement Tolerability
Time frame: Day of Procedure (Day 0) Immediately following tube placement
Mean subject-reported pain score following TDS tube placement using the Faces Pain Scale-Revised (FPS-R) (pivotal cohort children ages 5 and older only). The FPS-R has 6 faces which permits scaling to a 0-to-10 scoring system in intervals of 2 (ie 0, 2, 4, 6, 8 and 10), where 0 represents 'no pain' and 10 represents 'very much pain'. Note- the primary endpoint applies only to the Pivotal Cohort, and not to the OR Lead-In or Office Lead-In cohorts.
3 secondary outcomes
Tube Patency
Time frame: 3 Weeks Post Procedure
Tube Retention
Time frame: 3 Weeks Post Procedure
Anesthesia Effectiveness
Time frame: Day of Procedure (Day 0)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 May 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for OME - Otitis Media With Effusion
Recruiting
CLIKX® Tympanostomy Tube Delivery System for the Placement of Tympanostomy Tubes
Otitis Media, Otitis Media Chronic
Not yet recruiting
Short-term Application of Lactoferrin Ventilation Tubes
Otitis Media With Effusion (OME)
Recruiting
Towards Implementation of Universal Newborn Hearing Screening in Kenya
Hearing Loss, Bilateral or Unilateral, Otitis Media With Effusion in Children
Not yet recruiting
EarFlo: A Non-Invasive Treatment for Otitis Media With Effusion & Eustachian Tube Dysfunction in Adults
Otitis Media With Effusion (OME), Eustachian Tube Dysfunction
Recruiting
SWIR Otoscopy Study
Otitis Media, Otitis Media Chronic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lawrence Lustig principal investigator
Columbia University
19 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Iontophoresis & tube placement and Tube placement in people with OME - Otitis Media With Effusion and AOM - Acute Otitis Media, run by Tusker Medical at 19 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 31 Jan 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedural Success: (time frame: Day of Procedure (Day 0) Immediately following tube placement). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 May 2022.