CompletedNot Applicable

A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery

United States60 participantsStarted 2011-12

Plain-language summary

The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.

Age range18 Years – 65 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✕. History of removal of one or both middle turbinates
✕. Significant sinonasal polyps
✕. Presence of marked septal asymmetry
✕. Presence of significant concha bullosa, which requires surgical excision
✕. Presence of non-viable tissue at the implantation site
✕. Has an autoimmune disease, e.g., lupus, Graves' disease, myasthenia gravis, Wegener's granulomatosis
✕. Known or suspected allergy to device components
✕. Participating in another clinical trial which could affect the healing of the middle turbinate

Miller synechia score at 8 weeks

Timeframe: 8 weeks post endoscopic sinus surgery

NCT IDNCT01733667

SponsorENTrigue Surgical, Inc.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2012-12