Mystery device trial raises questions
NCT ID NCT06862674
First seen Jun 25, 2026 · Last updated Sep 17, 2026 · Updated 3 times
Summary
This clinical trial is testing a medical device that has not been approved or cleared by the U.S. FDA. The trial's status is currently withheld, meaning key details about its progress and results are not publicly available. The purpose appears to be gathering information about the device's use.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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24 people
The number who actually took part.
- Started
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Sep 2024
- Finished
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Jan 2026
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: Participant Must: * Be ≥18 years of age. * Have Chronic Migraine * Be willing and able to comply with all study elements, as indicated by written informed consent. Exclusion Criteria: Participant Must Not: * Have diagnosis or history of complicated migraine, basilar migraine, ophthalmoplegic migraine, hemiplegic migraine, or migrainous infarction. * Progressive neurologic disorder other than migraine. * Have clinically significant anatomic obstruction that in the investigator's opinion limit access to the posterior nose, including but not limited to severe septal deviation or perforation, nasal polyps, and/or sinonasal tumor. * Have plans to (or otherwise anticipates the need to) undergo an ENT procedure concurrently or during study. * Have had previous sinus or nasal surgery within 6 months of study enrollment. * Have previously undergone radiofrequency, cryotherapy, or other surgical interventions for rhinitis. * Have started a new migraine medication regimen within 3 months of study enrollment that, according to the manufacturer's labeling, has not yet stabilized. * Have an acute nasal or sinus infection. * Have nasal mucosal erosion/ulceration. * Be on prescribed anticoagulants (eg, warfarin, Plavix) or 325 mg aspirin that cannot be held for an appropriate time before the procedure. * Have hemophilia. * Have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months. * Have numbness of the soft palate, excessive dry eye, excessive dry nose, or other indication of neuro/nerve compromise in the sinonasal cavity. * Have had previous head and/or neck irradiation. * Be pregnant. * Have a physical, neurological, medical, psychiatric condition or situation that, in the investigator's opinion, puts the participant at risk, could confound the study results, or may interfere significantly with the participant's participation in the study. * Be participating in another clinical research study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Ascension St. Vincent
Anderson, Indiana, 46016, United States
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East Alabama ENT
Opelika, Alabama, 36801, United States
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ExcelENT
Birmingham, Alabama, 36801, United States
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Sacramento ENT
Sacramento, California, 95661, United States
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Sensa Health
Los Angeles, California, 90006, United States
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Senta Clinic
San Diego, California, 92108, United States
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Specialty Physician Associates
Bethlehem, Pennsylvania, 18017, United States
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Other studies related to the condition(s) this trial covers.
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