SinusitisMTINCT00896883
Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
A study testing Middle Turbinate Implant in people with Sinusitis, run by ENTrigue Surgical, Inc. at 4 sites in United States.
Trial summary
The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines clinical relevance. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sinusitis
- What is being tested?
- Middle Turbinate Implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 4 sitesUnited States
- Study dates
- Apr 2009to May 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery.
- Subject is able to provide a signed informed consent form.
- Subject will agree to comply with all study-related procedures.
- Subject is not pregnant at this time by confirmation of one of the following:
- Subject is male
- Subject not of child bearing age
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- Subject is surgically sterile
- Subject is not pregnant per negative hCG test
- Subject does not plan on becoming pregnant and is not breast feeding during the course of the study.
Who cannot join
- Subject does not meet inclusion criteria.
- Presence of non-viable tissue at the implantation site.
- History of septal perforation.
- History of polyps.
- Presence of concha bullosa.
- Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea.
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- Subject is participating in a clinical trial which could affect the healing of the middle turbinate.
- Subject has uncontrolled diabetes.
- Subject is a:
- smoker
- severe drug abuser
- severe alcohol abuser
- Subject has an autoimmune disease deemed clinically significant by the Principal Investigator.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Texas Sinus Center
Boerne, Texas, 78006
Texas ENT and Allergy
College Station, Texas, 77845
San Antonio Ear, Nose and Throat Research
San Antonio, Texas, 78229
Becker Nose and Sinus Center
Sewell, New Jersey, 08080
About this study
Official title: A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines clinical relevance.
- Conditions
- Sinusitis
- Being tested
- Middle Turbinate Implant
- Keywords
- turbinate, implant, sinus surgery, Turbinates
- Medical subject headings
- Sinusitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Middle Turbinate ImplantDevice
Also called MTI
Middle Turbinate Implant placement at time of surgery and follow ups.
| Study group | Role | What they receive |
|---|---|---|
| Middle Turbinate Implant | Experimental | Subjects to receive Middle Turbinate Implant Receives: Device: Middle Turbinate Implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional performance of the MTI
Measured: 1 month
Secondary outcomes (1)
Visual tissue reaction to the Middle Turbinate Implant
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2009 (estimated)
- Study startApr 2009
- Primary completionNov 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SinusitisStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENTrigue Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ronald B Kuppersmith, MD, Principal investigator, Texas ENT and Allergy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00896883
- Sponsor's protocol ID
- CSA2008-02
- Acronym
- MTI
- Status last verified
- Aug 2012
- First submitted
- 8 May 2009
- Last updated
- 23 Aug 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Non-Randomized, Limited-Use Evaluation of the Middle Turbinate Implant for Affixing the Middle Turbinate to the Nasal Septum
- ClinicalTrials.gov ID
- NCT00896883
- Acronym / sponsor ID
- MTI / CSA2008-02
- Conditions
- Sinusitis
- Keywords
- turbinate, implant, sinus surgery, Turbinates
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- ENTrigue Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Nov 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 12 May 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the functional performance of the Middle Turbinate Implant (MTI). The MTI will be used in all patients requiring endoscopic sinus surgery in which the Principal Investigator determines clinical relevance.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Middle Turbinate Implant | Experimental | Device: Middle Turbinate ImplantSubjects to receive Middle Turbinate Implant |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject is between the ages of 18 and 65 years and will be receiving endoscopic sinus surgery.
- Subject is able to provide a signed informed consent form.
- Subject will agree to comply with all study-related procedures.
- Subject is not pregnant at this time by confirmation of one of the following:
Key exclusion criteria (13 listed)
- Subject does not meet inclusion criteria.
- Presence of non-viable tissue at the implantation site.
- History of septal perforation.
- History of polyps.
- Presence of concha bullosa.
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 |
|---|---|---|
| Middle Turbinate ImplantAlso: MTIMiddle Turbinate Implant placement at time of surgery and follow ups. | Device | Middle Turbinate Implant |
Primary outcome
Functional performance of the MTI
Time frame: 1 month
1 secondary outcome
Visual tissue reaction to the Middle Turbinate Implant
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2012.
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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.
Ronald B Kuppersmith, MD principal investigator
Texas ENT and Allergy
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Middle Turbinate Implant in people with Sinusitis, run by ENTrigue Surgical, Inc. at 4 sites in United States.
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 9 inclusion and 13 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 23 Aug 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Functional performance of the MTI (time frame: 1 month). 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 23 Aug 2012.