Trials / Completed
CompletedNCT02880514
In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- Intersect ENT · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Accepted
Summary
A randomized controlled trial
Detailed description
This is a prospective, randomized, single-blind, intra-patient controlled, multicenter trial with 50 subjects enrolled at up to 15 sites across the United States. Study subjects undergo implant placement on one side following in-office balloon dilation, while the contralateral side undergoes balloon dilation only and serves as a control.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PROPEL Mini Sinus Implant | Sinus implant with 370 mcg of mometasone furoate released over 30 days |
| PROCEDURE | Balloon Sinus Dilation Alone |
Timeline
- Start date
- 2016-08-01
- Primary completion
- 2016-12-01
- Completion
- 2017-06-01
- First posted
- 2016-08-26
- Last updated
- 2018-12-10
- Results posted
- 2018-12-10
Locations
9 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT02880514. Inclusion in this directory is not an endorsement.