RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid‐eluting sinus implants for in‐office treatment of recurrent sinonasal polyposis

@article{Han2014RESOLVEAR,
  title={RESOLVE: a randomized, controlled, blinded study of bioabsorbable steroid‐eluting sinus implants for in‐office treatment of recurrent sinonasal polyposis},
  author={Joseph K. Han and Keith D Forwith and Timothy L. Smith and Robert C Kern and William J Brown and Steven K Miller and Randall A. Ow and David M. Poetker and Boris I Karanfilov and Keith E. Matheny and James W. Stambaugh and Anna K Gawlicka},
  journal={International Forum of Allergy \& Rhinology},
  year={2014},
  volume={4},
  pages={861 - 870}
}
Patients with recurrent sinonasal polyposis after endoscopic sinus surgery (ESS) have limited treatment options. This study evaluated the safety and efficacy of a bioabsorbable steroid‐eluting implant with 1350 μg of mometasone furoate for its ability to dilate obstructed ethmoid sinuses, reduce polyposis, and reestablish sinus patency. 
View on Wiley
uclahealth.org
49 Citations
Highly Influential Citations
1
Background Citations
13
Methods Citations
1

49 Citations

Citation Type

Citation Type

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
TLDR
Safety and efficacy were previously reported for a bioabsorbable sinus implant that elutes mometasone furoate for 3 months, and longer‐term outcomes are summarized.
Effects of implants with steroids after endoscopic sinus surgery: A systematic review with meta‐analysis of randomized controlled trials
TLDR
Examination of the efficacy of steroid implants after ESS by synthesizing relevant randomized controlled trials (RCTs) indicates that evidence on this topic is of low quality with high heterogeneity.
A phase 3 trial of mometasone furoate sinus implants for chronic sinusitis with recurrent nasal polyps
TLDR
A corticosteroid‐eluting sinus implant was designed to address limitations in patients with recurrent polyposis after sinus surgery by delivering 1350 μg of mometasone furoate directly to the ethmoid sinus mucosa over approximately 90 days.
Comparison of Bioabsorbable Steroid-Eluting Sinus Stents Versus Nasopore After Endoscopic Sinus Surgery: A Multicenter, Randomized, Controlled, Single-Blinded Clinical Trial.
TLDR
A significant improvement in the early postoperative outcomes was demonstrated by reducing the need for postoperative surgical intervention and polyp formation using steroid-eluting stents when compared with absorbable Nasopore packs.
Trends in the Use of Stents and Drug-Eluting Stents in Sinus Surgery.
Drug‐eluting implants in chronic rhinosinusitis: an evidence‐based review with recommendations
TLDR
The objective of this study was to review drug‐eluting implants designed for use in the sinonasal cavity through an evidence‐based review with recommendations.
Implantable Sinus Stents for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease
  • Medicine
  • 2014
TLDR
Functional ESS is typically performed on patients with chronic rhinosinusitis unresponsive to conservative treatment, and has rapidly increased in frequency, with an estimated 250,000 procedures performed annually in the United States.
Name of Policy : Implantable Sinus Stents and Drug-Eluting Implants for Postoperative Use Following Endoscopic Sinus Surgery and for Recurrent Sinus Disease
  • Medicine
  • 2018
TLDR
The technology must improve the net health outcome and be as beneficial as any established alternatives and the improvement must be attainable outside the investigational setting.
In-office Placement of Mometasone Furoate Sinus Implants for Recurrent Nasal Polyps: A Pooled Analysis
TLDR
MF implants with MFNS showed more favorable results than MFNS alone across several subjective and objective end points at day 90 and may play an important role in management of NP patients, especially those who have allergic rhinitis, expanded polyposis, altered smell, or had most recent ESS.
Phase 1 clinical study to assess the safety of a novel drug delivery system providing long‐term topical steroid therapy for chronic rhinosinusitis
TLDR
A novel biodegradable mometasone furoate drug delivery system (LYR‐210) providing continuous topical steroid therapy to sinonasal mucosa over 24 weeks was developed to treat unoperated CRS patients who have failed medical management prior to ESS.
...
1
2
3
4
5
...

References

SHOWING 1-10 OF 30 REFERENCES
Steroid‐eluting sinus implant for in‐office treatment of recurrent nasal polyposis: a prospective, multicenter study
TLDR
A bioabsorbable, steroid‐eluting implant was studied for its ability to dilate sinuses obstructed by polyps and provide localized, controlled steroid delivery to reestablish sinus patency.
Safety and efficacy of a novel bioabsorbable, steroid‐eluting sinus stent
TLDR
The study objective was to assess safety and efficacy of a steroid‐eluting sinus stent when used following functional endoscopic sinus surgery (FESS) in patients with chronic rhinosinusitis (CRS).
ADVANCE: A multisite trial of bioabsorbable steroid‐eluting sinus implants
TLDR
The safety and effectiveness of a bioabsorbable, steroid‐eluting implant used following functional endoscopic sinus surgery in patients with chronic rhinosinusitis (CRS) was assessed.
Effect of steroid‐releasing sinus implants on postoperative medical and surgical interventions: an efficacy meta‐analysis
TLDR
A meta‐analysis of the efficacy results from 2 prospective, randomized clinical trials of a bioabsorbable, steroid‐releasing sinus implant for its ability to preserve sinus patency and reduce medical and surgical interventions after ESS in patients with CRS was performed.
Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi‐institutional study
TLDR
This study evaluates outcomes in patients who failed initial medical management and elect a subsequent treatment option, either continued medical management or endoscopic sinus surgery coupled with continuing medical management.
Medical therapy vs surgery for chronic rhinosinusitis: a prospective, multi‐institutional study with 1‐year follow‐up
This study evaluated 1‐year outcomes in patients with chronic rhinosinusitis (CRS) who were considered surgical candidates by study criteria and elected either medical management or endoscopic sinus…
Advance II
TLDR
This study provides a high level of evidence that use of steroid-releasing implants that apply a sustained release of corticosteroid improves surgical outcomes by reducing synechiae formation, polyposis, and the need for postoperative interventions, with no observable ocular safety risk.
Use of mometasone furoate to prevent polyp relapse after endoscopic sinus surgery.
TLDR
Postoperative use of mometasone furoate, 200 microg once daily, provided a statistically significant longer time to relapse of nasal polyps than did placebo in subjects with bilateral nasal polyposis who had undergone functional endoscopic sinus surgery.
The use of postoperative topical corticosteroids in chronic rhinosinusitis with nasal polyps: A systematic review and meta-analysis
TLDR
Topical intranasal corticosteroids use is a safe therapy in postoperative management of CRSwNP patients and INCS showed significant improvement in polyp score, patients’ symptoms and significant decrease inpolyp recurrence in the first year postoperatively.
Short course of systemic corticosteroids in sinonasal polyposis: A double‐blind, randomized, placebo‐controlled trial with evaluation of outcome measures
TLDR
A 14-day course of 50 mg of prednisolone is safe and effective therapy for symptomatic nasal polyposis and MRI scanning and quantitative nasendoscopic photography are objective and valid tools for assessing the outcome of treatment in this condition.
...
1
2
3
...