Nasal Airway ObstructionNCT01960816
InFlux System for Nasal Breathing Improvement
A study testing Procedure: thermal coagulation of tissue in the nasal airway in people with Nasal Airway Obstruction, run by Aerin Medical at 2 sites in United States.
Trial summary
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Nasal Airway Obstruction
- What is being tested?
- Procedure: thermal coagulation of tissue in the nasal airway
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 2 sitesUnited States
- Study dates
- Sep 2013to Apr 2016
- Phase
- Interventional
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with history of Chronic nasal obstruction and Poor nasal breathing
Who cannot join
- Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
St. Elizabeth's Medical Center
Boston, Massachusetts, 02135
Bay Area ENT
Ocean Springs, Mississippi, 39564
About this study
Official title: Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
Read the detailed description
This is a non-significant risk, prospective, non-randomized pilot study to evaluate the incidence of serious adverse events directly attributable to the Aerin Medical Wand, when used to deliver radiofrequency (RF) energy to tissues of the nasal airway for the treatment of nasal obstruction.
- Conditions
- Nasal Airway Obstruction
- Being tested
- Procedure: thermal coagulation of tissue in the nasal airway
- Keywords
- nasal obstruction
- Medical subject headings
- Nasal Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Procedure: thermal coagulation of tissue in the nasal airwayDevice
Also called Vivaer Stylus, Aerin Medical Wand
The Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage.
| Study group | Role | What they receive |
|---|---|---|
| InFlux System | Experimental | Intervention: Procedure: thermal coagulation of tissue in the nasal airway Receives: Device: Procedure: thermal coagulation of tissue in the nasal airway |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Unanticipated Serious Adverse Device Effects
The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)
Measured: 90 Days
Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue
Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.
Measured: Procedure, up to 1 hour (average, 16 minutes)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionJan 2016
- Study completionApr 2016
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 Nasal Airway ObstructionStudies 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aerin Medical
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Peter Catalano, MD, Principal investigator, Steward Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01960816
- Sponsor's protocol ID
- TP026
- Status last verified
- Aug 2016
- First submitted
- 8 Oct 2013
- Last updated
- 26 Sep 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Aerin Medical's InFlux System for Improvement in Nasal Breathing
- ClinicalTrials.gov ID
- NCT01960816
- Acronym / sponsor ID
- TP026
- Conditions
- Nasal Airway Obstruction
- Keywords
- nasal obstruction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Aerin MedicalIndustry (pharma, biotech, devices)
- Study start
- Sep 2013
- Primary completion
- Jan 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 11 Oct 2013 (estimated)
- Results
- Posted 19 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
Detailed description
This is a non-significant risk, prospective, non-randomized pilot study to evaluate the incidence of serious adverse events directly attributable to the Aerin Medical Wand, when used to deliver radiofrequency (RF) energy to tissues of the nasal airway for the treatment of nasal obstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| InFlux System | Experimental | Device: Procedure: thermal coagulation of tissue in the nasal airwayIntervention: Procedure: thermal coagulation of tissue in the nasal airway |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients with history of Chronic nasal obstruction and Poor nasal breathing
Key exclusion criteria (1 listed)
- Patients with prior nasal history, nasal pathology, or injury, and/or other conditions that may interfere with participation in the study
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 |
|---|---|---|
| Procedure: thermal coagulation of tissue in the nasal airwayAlso: Vivaer Stylus, Aerin Medical WandThe Vivaer Stylus is used to deliver low-power, temperature-controlled, radiofrequency energy to tissues of the nasal airway to cause coagulation of soft tissues and submucosal tissue shrinkage. | Device | InFlux System |
Primary outcome
Incidence of Unanticipated Serious Adverse Device Effects
Time frame: 90 Days
The study will be considered to have met its primary safety endpoint if no subject experiences an unanticipated serious adverse device effect (USADE defined as any serious adverse effect caused by, or associated with, the investigational device, that was not previously identified in nature, severity, or degree of incidence in the protocol)
Technical Feasibility as Assessed by the Ability of the InFlux Device to Deliver RF Energy to Target Tissue
Time frame: Procedure, up to 1 hour (average, 16 minutes)
Ability of the InFlux device to deliver RF energy at the selected power setting, and to reach and maintain the selected target temperature.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Sep 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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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.
Peter Catalano, MD principal investigator
Steward Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procedure: thermal coagulation of tissue in the nasal airway in people with Nasal Airway Obstruction, run by Aerin Medical at 2 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 1 inclusion and 1 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 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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?
Yes. Results are posted in the registry (first posted 19 Aug 2016). 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?
Incidence of Unanticipated Serious Adverse Device Effects (time frame: 90 Days). 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 Sep 2016.