Last reviewed · How we verify
NCT02347943: OASIS
Global Sinus Surgery Registry
trial in Chronic Rhinosinusitis in 252 participants. Terminated before completion.
1 November 2015
Quick facts
| Lead sponsor | Integra LifeSciences Corporation |
|---|---|
| Status | Terminated |
| Study type | OBSERVATIONAL |
| Enrollment | 252 |
| Start date | 1 January 2015 |
| Primary completion | 1 November 2015 |
| Estimated completion | 1 November 2015 |
| Sites | 25 locations across United States |
Conditions studied
- Chronic Rhinosinusitis — all drugs for Chronic Rhinosinusitis →
- Recurrent Acute Rhinosinusitis — all drugs for Recurrent Acute Rhinosinusitis →
Sponsor
Integra LifeSciences Corporation — full company profile →
Who can join
18 and older, any sex, with Chronic Rhinosinusitis or Recurrent Acute Rhinosinusitis. Patients with the condition only — healthy volunteers not accepted.
Adverse events — posted to ClinicalTrials.gov
Reporting threshold: 0.1%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Serious adverse events (2 terms)
| Reaction | System | Balloon Sinus Dilation (BSD) | Endoscopic Sinus Surgery (… | Hybrid |
|---|---|---|---|---|
| Acute pulmonary oedema | Respiratory, thoracic and mediastinal disorders | — | — | — |
| pneumonia | Infections and infestations | — | — | — |
Other adverse events (13 terms — click to expand)
| Reaction | System | Balloon Sinus Dilation (BSD) | Endoscopic Sinus Surgery (… | Hybrid |
|---|---|---|---|---|
| Vertigo positional | Ear and labyrinth disorders | — | — | — |
| Vomiting | Gastrointestinal disorders | — | — | — |
| Drug hypersensitivity | Immune system disorders | — | — | — |
| Hypersensitivity | Immune system disorders | — | — | — |
| Folliculitis | Infections and infestations | — | — | — |
| Influenza | Infections and infestations | — | — | — |
| Sinusitis | Infections and infestations | — | — | — |
| Migraine | Nervous system disorders | — | — | — |
| Sinus headache | Nervous system disorders | — | — | — |
| Anxiety | Psychiatric disorders | — | — | — |
| Cough | Respiratory, thoracic and mediastinal disorders | — | — | — |
| Hypertension | Vascular disorders | — | — | — |
| Dehiscence in the lamina papyracea | Surgical and medical procedures | — | — | — |
Most-reported serious reactions: Acute pulmonary oedema, pneumonia.
Data from ClinicalTrials.gov NCT02347943 adverse events section.
Sponsor's own description
This study evaluates long-term safety and effectiveness of primary sinus surgery in a real-world population of adults with chronic rhinosinusitis (CRS) or recurrent acute rhinosinusitis (RARS). This post-market study will evaluate sinus surgery performed using commercially available sinus instrumentation (e.g. sinus balloon catheters, powered microdebriders, manual instruments).
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT02347943
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Chronic Rhinosinusitis
Currently open trials in the same condition.
- NCT06920576 — Effects of Esketamine Versus Magnesium Sulfate on Emotional State and Postoperative Pain in Patients Undergoing Nasal En · Phase 1, PHASE2 · active not recruiting
- NCT06457100 — Esmolol Versus Lidocaine on the Quality of Postoperative Recovery in Patients Undergoing Functional Endoscopic Sinus Sur · Phase 1, PHASE2 · active not recruiting
- NCT07340411 — Effect of Chinese Herbal Medicine Nasal Irrigation on the Postoperative Care of Chronic Rhinosinusitis · Phase 2 · recruiting
- NCT05883462 — Paclitaxel-Coated Nasal Balloon for the Treatment of Recurrent Chronic Rhinosinusitis With or Without Nasal Polyps (FIH) · EARLY_PHASE1 · active not recruiting
- NCT05935683 — Rhinosinusitis Italian Network: the Italian Registry for Severe, Uncontrolled Chronic Rhinosinusitis · recruiting
Other Integra LifeSciences Corporation trials
Trials by the same sponsor.
- NCT06760611 — Tissue Quality of Integra vs. BTM Treated Burns · withdrawn
- NCT06629506 — MicroMatrix® Flex in Tunneling Wounds · NA · completed
- NCT06453187 — A Modified Platform Trial of Multiple CAMPs for the Management of Diabetic Foot Ulcers and Venous Leg Ulcers · NA · enrolling by invitation
- NCT06276543 — Bactiseal Catheter Safety Registry Study · recruiting
- NCT06297187 — Cavitronic Ultrasonic Surgical Aspiration (CUSA) Women's Health Study · 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 NCT02347943 (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 Integra LifeSciences Corporation
- Last refreshed: 12 July 2024
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/NCT02347943.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing