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NCT01960816 · ClinicalTrials.gov registry record · NA
InFlux System for Nasal Breathing Improvement
A NA study of Nasal Airway Obstruction, sponsored by Aerin Medical.
- Completed
- Registry status
- NA
- Development phase
- 33
- Enrollment target
- 2
- Study locations
NCT01960816: Completed NA study of Nasal Airway Obstruction, sponsored by Aerin Medical.
NCT01960816 is a NA study of Nasal Airway Obstruction that has completed, run by Aerin Medical. The registered enrollment target is 33 participants, below the 181-participant average among 3 other Nasal Airway Obstruction trials with a reported enrollment target (82% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01960816, a NA study of Nasal Airway Obstruction, has completed, sponsored by Aerin Medical.
- COMPLETED
- Registry status
- NA
- Development phase
- 33 participants
- Enrollment target
- 2
- Study locations
Study Summary
Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
Primary Outcome
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)
Conditions Studied
Interventions
- DEVICE Procedure: thermal coagulation of tissue in the nasal airway
Study Locations (2)
Massachusetts
- St. Elizabeth's Medical Center - Boston
Mississippi
- Bay Area ENT - Ocean Springs
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2013-09 |
| Est. Completion | 2016-04 |
| Phase | NA |
What the finished NCT01960816 record still lists
NCT01960816 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 33 participants, a relatively small participant target, below the 181-participant average among 3 other Nasal Airway Obstruction trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Nasal Airway Obstruction appearing as the primary indexed condition, and to 1 intervention - of which Procedure: thermal coagulation of tissue in the nasal airway is the first listed.
NCT01960816 reports a single indexed study location in Massachusetts, Mississippi.
Frequently Asked Questions
What is clinical trial NCT01960816 about?
NCT01960816 is a clinical study titled "InFlux System for Nasal Breathing Improvement". Pilot Study of the Aerin Medical Wand used for Improvement in Nasal Breathing
What is the current status of trial NCT01960816?
This trial is currently completed. It is a NA study. The enrollment target is 33 participants. The study started on 2013-09. Estimated completion is 2016-04.
What conditions does trial NCT01960816 study?
This clinical trial studies the following conditions: Nasal Airway Obstruction.
What interventions are being tested in trial NCT01960816?
The interventions under investigation include: Procedure: thermal coagulation of tissue in the nasal airway (DEVICE).
Who is sponsoring clinical trial NCT01960816?
This trial is sponsored by Aerin Medical, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01960816 being conducted?
This trial has 2 study locations across Massachusetts, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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