drugset / Trial / NCT01732536
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
RandomizedParallel-groupDouble-blindTreatment
Summary
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
Timeline
- Start
- 2013-01
- Primary completion
- 2013-11
- Completion
- 2014-05
Publications
- Background Han JK, Forwith KD, Smith TL, Kern RC, Brown WJ, Miller SK, Ow RA, Poetker DM, Karanfilov B, Matheny KE, Stambaugh J, Gawlicka AK. RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis. Int Forum Allergy Rhinol. 2014 Nov;4(11):861-70. doi: 10.1002/alr.21426. Epub 2014 Sep 29.
- Results Forwith KD, Han JK, Stolovitzky JP, Yen DM, Chandra RK, Karanfilov B, Matheny KE, Stambaugh JW, Gawlicka AK. RESOLVE: bioabsorbable steroid-eluting sinus implants for in-office treatment of recurrent sinonasal polyposis after sinus surgery: 6-month outcomes from a randomized, controlled, blinded study. Int Forum Allergy Rhinol. 2016 Jun;6(6):573-81. doi: 10.1002/alr.21741. Epub 2016 Mar 14.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Mometasone furoate | Other / unclassified | 200 ug | Other |
| Subject | Mometasone furoate | Other / unclassified | 1350 ug | Other |