Safety and Efficacy of Bioabsorbable Drug-Eluting Sinus Implant for Chronic Sinusitis (RESOLVE)
This study is currently recruiting participants.
Verified June 2013 by Intersect ENT
Sponsor:
Intersect ENT
Information provided by (Responsible Party):
Intersect ENT
ClinicalTrials.gov Identifier:
NCT01732536
First received: November 14, 2012
Last updated: June 6, 2013
Last verified: June 2013
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Purpose
The purpose of the study is to determine whether a steroid-eluting sinus implant if effective in improving chronic sinusitis symptoms in patients who experience recurrent blockage of the sinuses by polyps sometime after sinus surgery.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Sinusitis |
Drug: S8 sinus implant Drug: continued nasal steroid spray |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Clinical Evaluation of the Safety and Efficacy of the Steroid-Releasing S8 Sinus Implant Used in Post-Sinus Surgery Patients With Recurrent Sinus Obstruction |
Resource links provided by NLM:
Further study details as provided by Intersect ENT:
Primary Outcome Measures:
- nasal obstruction/congestion [ Time Frame: 3 months ] [ Designated as safety issue: No ]
- nasal polyposis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | January 2013 |
| Estimated Study Completion Date: | February 2014 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Drug Eluting Sinus Implant
S8 steroid eluting sinus implant and continued nasal steroid spray
|
Drug: S8 sinus implant |
|
Sham Comparator: Control
continued nasal steroid spray
|
Drug: continued nasal steroid spray |
Detailed Description:
A significant proportion of patients who undergo sinus surgery for chronic sinusitis later experience recurrent symptoms due to persisting disease and the regrowth of sinus polyps. For many patients this persisting disease proves to be refractory to medical therapy. Treatment options typically include further aggressive medical therapy or repeat sinus surgery. This study is designed to evaluate another treatment option in the form of a steroid-eluting sinus implant that is placed into the sinus and delivers the medication for up to 3 months to reduce sinus inflammation, polyposis and the associated sinus symptoms.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- diagnosis of chronic sinusitis
- prior sinus surgery with ethmoidectomy
- recurrent sinus obstruction due to polyps
- refractory to medical therapy
- indicated for revision sinus surgery
Exclusion Criteria:
- significant scarring of the sinus
- insulin dependent diabetes
- glaucoma or ocular hypertension
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01732536
Contacts
| Contact: Vicki Schreckengost, RN | 650-641-2102 | |
| Contact: James Stambaugh | 650-641-2103 |
Locations
| United States, California | |
| California Sinus Centers | Recruiting |
| Atherton, California, United States, 94027 | |
| Contact: Sharareh Derackshandeh, PA 650-399-4630 sinuspa@calsinus.com | |
| Principal Investigator: Winston Vaughan, MD | |
| Central California Ear, Nose, and Throat | Recruiting |
| Fresno, California, United States, 93720 | |
| Contact: JoAnn LaForti, RN, MS, CCRC 559-432-3303 ext 228 | |
| Principal Investigator: Brent Lanier, MD, CPI | |
| Cedars-Sinai Medical Center | Not yet recruiting |
| Los Angeles, California, United States, 90048 | |
| Contact: Denice Dubuclet 310-423-6996 Denice.Dubuclet@cshs.org | |
| Principal Investigator: Martin Hopp, MD | |
| Sacramento Ear, Nose and Throat | Not yet recruiting |
| Sacramento, California, United States, 95815 | |
| Contact: Bryan Hughes, CCRC 916-233-4156 ext 1024 bhughes@sacent.com | |
| Principal Investigator: Randall Ow, MD | |
| United States, Colorado | |
| Colorado Ear, Nose, Throat & Allergy | Recruiting |
| Colorado Springs, Colorado, United States, 80909 | |
| Contact: Deborah A Bothwell, CCRC 719-867-7810 dbothwell@coloradoent.com | |
| Principal Investigator: Joseph L Romett, MD | |
| United States, Georgia | |
| ENT of Georgia | Recruiting |
| Atlanta, Georgia, United States, 30342 | |
| Contact: Anisa Daftari, PA-C 404-297-4230 anisa@daftaris.com | |
| Principal Investigator: Jose P Stolovitzky, MD | |
| United States, Illinois | |
| Northwestern Medical Faculty Foundation, Department of Otolaryngology | Recruiting |
| Chicago, Illinois, United States, 60611 | |
| Contact: Donna Harakal, BA, BSN, RN 312-503-2160 d-harakal@northwestern.edu | |
| Principal Investigator: Rakesh Chandra, MD | |
| United States, Kentucky | |
| Advanced ENT & Allergy | Recruiting |
| Louisville, Kentucky, United States, 40207 | |
| Contact: Kathleen Sheeley 502-893-0159 ext 1185 ksheeley@commonwealthent.com | |
| Contact: Renee Dickerson 502-893-0159 ext 1184 rdickerson@commonwealthent.com | |
| Principal Investigator: Keith D Forwith, PhD, MD | |
| United States, New York | |
| ENT and Allergy Associates | Recruiting |
| Lake Success, New York, United States, 11042 | |
| Contact: Francine Schnabel 516-775-2800 fschnabel@entandallergy.com | |
| Principal Investigator: Todd Schaeffer, MD | |
| United States, North Carolina | |
| Charlotte Eye, Ear, Nose, and Throat | Recruiting |
| Charlotte, North Carolina, United States, 28210 | |
| Contact: Jenna T Herby, BS, CCRC 704-295-3270 jherby@ceenta.com | |
| Principal Investigator: Trevor I Goldberg, MD | |
| Piedmont Ear, Nose & Throat Associates | Recruiting |
| Winston-Salem, North Carolina, United States, 27103 | |
| Contact: Sandra Smith, MBA, CCRC 336-768-3361 ssmith@piedmontent.com | |
| Principal Investigator: Ronald Shealy, MD | |
| United States, Pennsylvania | |
| Bethlehem ENT Associates | Recruiting |
| Bethlehem, Pennsylvania, United States, 18017 | |
| Contact: Lisa Yen, NP 610-866-5555 resolvecrc15@gmail.com | |
| Principal Investigator: David M Yen, MD | |
| Perelmen School of Medicine at the University of Pennsylvania | Recruiting |
| Philadelphia, Pennsylvania, United States, 19104 | |
| Contact: Laurel Doghramji, RN, BSN 215-615-1643 laurel.doghramji@uphs.edu | |
| Principal Investigator: Nithin Adappa, MD | |
| United States, Utah | |
| Ear, Nose & Throat Center | Recruiting |
| Salt Lake City, Utah, United States, 84102 | |
| Contact: Holly Featherstone 801-328-2522 ext 1152 holly@entcenterslc.com | |
| Principal Investigator: Steven K Miller, MD | |
| United States, Virginia | |
| Eastern Virginia Medical School Department of Otolaryngology | Recruiting |
| Norfolk, Virginia, United States, 23507 | |
| Contact: Laura Stone 757-388-6238 StoneLJ@evms.edu | |
| Principal Investigator: Joseph K Han, MD | |
| United States, Wisconsin | |
| Medical College of Wisconsin | Not yet recruiting |
| Milwaukee, Wisconsin, United States, 53266 | |
| Contact: Christy Erbe 414-805-5581 cerbe@mcw.edu | |
| Principal Investigator: David M. Poetker, MD | |
Sponsors and Collaborators
Intersect ENT
More Information
No publications provided
| Responsible Party: | Intersect ENT |
| ClinicalTrials.gov Identifier: | NCT01732536 History of Changes |
| Other Study ID Numbers: | P500-1012 |
| Study First Received: | November 14, 2012 |
| Last Updated: | June 6, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Additional relevant MeSH terms:
|
Sinusitis Chronic Disease Paranasal Sinus Diseases Nose Diseases Respiratory Tract Diseases |
Respiratory Tract Infections Otorhinolaryngologic Diseases Disease Attributes Pathologic Processes |
ClinicalTrials.gov processed this record on June 18, 2013