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NCT01732536: RESOLVE
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
Phase 2/Phase 3 trial testing S8 Sinus Implant in Chronic Sinusitis in 100 participants. Completed in 1 May 2014.
1 November 2013
Quick facts
| Lead sponsor | Intersect ENT |
|---|---|
| Phase | Phase 2/Phase 3 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | double |
| Primary purpose | treatment |
| Enrollment | 100 |
| Start date | 1 January 2013 |
| Primary completion | 1 November 2013 |
| Estimated completion | 1 May 2014 |
| Sites | 19 locations across United States |
Drugs / interventions tested
- S8 Sinus Implant — full drug profile →
- Sham procedure — full drug profile →
- Mometasone furoate nasal spray — full drug profile →
Conditions studied
- Chronic Sinusitis — all drugs for Chronic Sinusitis →
- Nasal Polyps — all drugs for Nasal Polyps →
Sponsor
Intersect ENT — full company profile →
Who can join
18 and older, any sex, with Chronic Sinusitis or Nasal Polyps. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Nasal Obstruction/Congestion Score
Time frame: 90 days
Nasal Obstruction by patients using a paper questionnaire on a scale from 0 (no problem) to 5 (problem as bad as it can be). Negative values for change from baseline represented reduction (improvement) in -
Bilateral Polyp Grade
Time frame: 90 days
Polyp grade was determined by a panel of 3 independent sinus surgeons based on a centralized, blinded videoendoscopy review. Each sinus was graded from 0 (no visible polyps) to 4 (nasal polyps completely obstructing nasal cavity) and then the left and right values were added to obtain a total bilateral polyp grade, ranging from 0 to 8. Negative values for change from baseline represented reduction
Sponsor's own description
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT01732536
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of S8 Sinus Implant
Trials testing the same drug.
- NCT03358329 — Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) · Phase 3 · completed
Other Intersect ENT trials
Trials by the same sponsor.
- NCT04858802 — A Clinical Evaluation of PROPEL® Contour Sinus Implant · NA · completed
- NCT03599271 — A Clinical Evaluation of the Intersect ENT Sinus Device (ASCEND) · completed
- NCT03358329 — Safety Evaluation of Repeat Placement of the S8 Sinus Implant in Chronic Sinusitis Patients With Nasal Polyps (ENCORE) · Phase 3 · completed
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT01732536 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Intersect ENT
- Last refreshed: 18 July 2018
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01732536.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing