Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications

• Status: Unknown status
• Trial end date: 2017-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This is a randomized controlled first in man study. Study purpose is to assess safety and efficacy of Composite Removable Stent Composite Stent implantation post-endoscopic sinus surgery in terms of:

• Sinus tissue adhesions

• Middle turbinate lateralization into nasal septum i.e. postoperative opening reduction

• Inflammation

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: STS Medical
• Treatments: Epinephrine; Epinephryl borate; Lidocaine; Racepinephrine

Criteria

Inclusion Criteria:

• Male/Female, 18 year or older

• Diagnosis of Recurrent Rhinosinusitis defined as symptomatic inflammation of the sinuse of at least 12 consecutive weeks duration

• CT scan examination with a minimum Lund-MacKay stage of 4 prior to study entry

• Planned Endoscopic Sinus surgery

Exclusion Criteria:

• Pregnant or lactating female

• History of immune deficiency

• Known allergy to Nickel

• Known Polyurethane induced dermatitis

• Cystic Fibrosis

• Severe Polyposis

• Sinonasal tumors

• Ciliary Disfunction

• Acute Sinus Inflammation