SynechiaMISTYNCT01733667
A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
A study testing MediENT and MeroPack in people with Synechia, run by ENTrigue Surgical, Inc. at 5 sites in United States.
Trial summary
The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Synechia
- What is being tested?
- MediENT and MeroPack
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 5 sitesUnited States
- Study dates
- Dec 2011to Feb 2013
- 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
- Subject scheduled to undergo bilateral endoscopic sinus surgery
- Subject signs IRB-approved informed consent form
- Subject agrees to comply with all study-related procedures
Who cannot join
- History of removal of one or both middle turbinates
- Significant sinonasal polyps
- Presence of marked septal asymmetry
- Presence of significant concha bullosa, which requires surgical excision
- Presence of non-viable tissue at the implantation site
- Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis
Show all 14Show fewer
- Known or suspected allergy to device components
- Participating in another clinical trial which could affect the healing of the middle turbinate
- Uncontrolled diabetes
- Known or suspected use of illicit drugs
- Known or suspected alcoholism
- Other medical illness that could prevent follow-up or increase the risk of surgery
- Pregnant or unwilling to take pregnancy prevention measures
- Subject is currently using CPAP (Continuous Positive Airway Pressure) for sleep apnea
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Colorado ENT & Allergy
Colorado Springs, Colorado, 80909
Central California ENT Medical Group
Fresno, California, 93720
Advanced ENT and Allergy
Louisville, Kentucky, 40207
ENT Associates of Texas
McKinney, Texas, 75079
Ear, Nose & Throat Clinics of San Antonio
San Antonio, Texas, 78229
About this study
The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.
Read the detailed description
MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.
- Conditions
- Synechia
- Being tested
- MediENT, MeroPack
- Keywords
- synechia, Fess, sinus surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediENTDevice
Also called MeroPack
MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
MeroPackDevice
MediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT
| Study group | Role | What they receive |
|---|---|---|
| MediENT | Experimental | Right or left sinus cavity where MediENT will be place after randomization. Receives: Device: MediENT |
| MeroPack | Active comparator | Right or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned. Receives: Device: MeroPack |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miller synechia score at 8 weeks
Miller synechia score at 8 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 8 weeks judged by an independent evaluator)
Measured: 8 weeks post endoscopic sinus surgery
Secondary outcomes (1)
Miller Score at 4 & 8 weeks
- Miller synechia score at 4 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 4 weeks judged by an independent evaluator)
- Total mean Miller score at 8 weeks
Measured: 4 & 8 weeks post endoscopic sinus surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2012 (estimated)
- Study startDec 2011
- Primary completionDec 2012
- Study completionFeb 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SynechiaStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- ENTrigue Surgical, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01733667
- Sponsor's protocol ID
- CSA2011-01
- Acronym
- MISTY
- Status last verified
- Jun 2013
- First submitted
- 21 Nov 2012
- Last updated
- 5 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
- ClinicalTrials.gov ID
- NCT01733667
- Acronym / sponsor ID
- MISTY / CSA2011-01
- Conditions
- Synechia
- Keywords
- synechia, Fess, sinus surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- ENTrigue Surgical, Inc.Industry (pharma, biotech, devices)
- Study start
- Dec 2011
- Primary completion
- Dec 2012 (actual)
- Study completion
- Feb 2013 (actual)
- First posted
- 27 Nov 2012 (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 compare the safety and effectiveness of MediENT to MeroPack after FESS.
Detailed description
MediENT is designed to minimize lateralization of the middle turbinate, which can cause scarring and obstruction of key sinus openings after endoscopic sinus surgery.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MediENT | Experimental | Device: MediENTRight or left sinus cavity where MediENT will be place after randomization. |
| MeroPack | Active comparator | Device: MeroPackRight or left sinus cavity where MeroPack will be placed after randomization of MediENT is assigned. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subject is between the ages of 18 and 65 years
- Subject scheduled to undergo bilateral endoscopic sinus surgery
- Subject signs IRB-approved informed consent form
- Subject agrees to comply with all study-related procedures
Key exclusion criteria (14 listed)
- History of removal of one or both middle turbinates
- Significant sinonasal polyps
- Presence of marked septal asymmetry
- Presence of significant concha bullosa, which requires surgical excision
- Presence of non-viable tissue at the implantation site
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 |
|---|---|---|
| MediENTAlso: MeroPackMediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT | Device | MediENT |
| MeroPackMediENT will be assigned to either the right or left side and positioned between the turbinate and nasal wall of the side assigned. MeroPack will be place in between the turbinate and nasal wall of the side not assigned to MediENT | Device | MeroPack |
Primary outcome
Miller synechia score at 8 weeks
Time frame: 8 weeks post endoscopic sinus surgery
Miller synechia score at 8 weeks (Number and degree of synechia present between middle turbinate and lateral nasal wall at 8 weeks judged by an independent evaluator)
1 secondary outcome
Miller Score at 4 & 8 weeks
Time frame: 4 & 8 weeks post endoscopic sinus surgery
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 5 Jun 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MediENT and MeroPack in people with Synechia, run by ENTrigue Surgical, Inc. at 5 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 4 inclusion and 14 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 5 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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?
Miller synechia score at 8 weeks (time frame: 8 weeks post endoscopic sinus surgery). 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 5 Jun 2013.