Clinical Trial: A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation
Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional
Official Title: A Clinical Evaluation of Propel Mini Sinus Implant Placement in the Frontal Sinus Ostia Following In-office Dilation
Brief Summary: A prospective, randomized, single-blind, intra-patient controlled, multicenter study
Detailed Summary: 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.
Sponsor: Intersect ENT
Current Primary Outcome: Inflammation Score [ Time Frame: Day 30 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Inflammation Score [ Time Frame: Day 90 ]
- Inflammation Score [ Time Frame: Day 180 ]
Original Secondary Outcome: Same as current
Information By: Intersect ENT
Dates:
Date Received: August 18, 2016
Date Started: August 2016
Date Completion: September 2017
Last Updated: March 19, 2017
Last Verified: October 2016
