N/A
N=14
Study to Evaluate the Safety and Initial Effectiveness of the Sinusway™ for Endoscopy of Sinuses in Conjunction With BSD
Sinusitis
Bottom Line
View on ClinicalTrials.gov: NCT03390257 ↗Enrolled (actual)
14
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Number of Adverse Device Effects — 0 events
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- 3NT flexible endoscope (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- 3NT Medical Ltd.
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Adverse Device Effects |
— | — |
| SECONDARY Percent of Sinuses Accessed and Visualized Successfully |
60.5; 100; 68.5 | — |
| SECONDARY User Satisfaction (1-bad, 5-good) |
4; 4.4; 4.5; 4.6; 4.8; 4.6 | — |
Summary
3NT flexible endoscope is a single-use disposable handheld endoscope that provides a means to visualize the nasal cavity and paranasal sinus space and deliver irrigation to treat the sinus ostia and spaces within the paranasal sinus cavities for diagnostic and therapeutic procedures
Eligibility Criteria
Inclusion Criteria
- Male or female patient indicated for balloon sinus dilation procedure by the ENT specialist
- Patient age: adult (>18 years old)
- Patients in general good health in the opinion of the investigator as determined by medical history and physical examination
- A patient who is able to understand the requirements of the study, is willing to comply with its instructions and schedules, and agrees to sign the informed consent
Exclusion Criteria
- Known history of any significant medical disorder, which in the investigator's judgment contraindicates the patient's participation
- Patients with known current or previous bleeding disorder receiving anticoagulants (e.g., chronic Coumadin treatment)
Data sourced from ClinicalTrials.gov (NCT03390257). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.