EFS of Bioabsorbable Implant for NSD (NCT05967169) | Clinical Trial Compass
CompletedNot Applicable
EFS of Bioabsorbable Implant for NSD
United States21 participantsStarted 2022-05-25
Plain-language summary
Early feasibility study of bioabsorbable implant and delivery device for correction of septal deviation
Who can participate
Age range21 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Non-calcified, mobile cartilaginous septal deviation.
* ≥21 years of age.
* Willing and able to provide informed consent and comply with the study protocol.
* Seeking treatment for nasal airway obstruction (NAO) due to septal deviation and is willing to undergo a nasal implant procedure.
* Type I, II, or III septal deviation as defined by 7-Degree Mladina classification scheme
* NOSE score ≥30 at Screening Visit.
* Appropriate nasal anatomy to receive the implant(s).
Exclusion Criteria:
* Type IV, V, VI or VII septal deviation as defined by 7-Degree Mladina classification scheme (See Table 2) or other non-cartilaginous septum anatomical pathology identified on CT scan suspected by Investigator to be the primary contributor to NAO.
* Having a concurrent ENT procedure, other than turbinate reduction.
* Previous septoplasty or rhinoplasty.
* Has had turbinate reduction or other nasal surgeries within the past six (6) months.
* Plans to have any surgical or non-surgical treatment of their nasal septum, other than the index procedure, within six (6) months of the procedure.
* Permanent implant or dilator in the nasal area.
* Concomitant autoimmune, inflammatory, or infectious skin conditions, unhealed wounds, septal perforation, or mucosal irregularities in the treatment area.
* Currently has active nasal vestibulitis or folliculitis.
* History of nasal vasculitis.
* Current or chronic systemic steroid and/or recreational intra-nasal drug user.
* Has had a…
What they're measuring
1
Number of participants with successful implantation as measured through physician's assessment and patient reported outcomes