Clinical trials: Sinus Disease
Cardiac Resynchronization Therapy, Chronic Heart Failure
Cardiac Resynchronization Therapy Delivery Guided Non-Invasive Electrical and Venous Anatomy Assessment
The objective of this prospective, multicenter controlled study is to assess the feasibility of a patient-tailored implantation by creating a cloud-based pre-procedural multimodality CRT-roadmap by integration of 3D images from…
- Conditions
- Cardiac Resynchronization Therapy, Chronic Heart Failure, Left Bundle-Branch Block
- Trial name
- CRT-DRIVE (NCT05327062)
- Testing
- CRT implantation guided by XSpline, a non-invasive electrical and venous anatomy assessment
- Where
- 13 sites in United States, Austria and 5 more
- Volunteers
- 150 people
- Sponsor
- XSpline S.p.A.
Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis
Dupilumab in CRSsNP
Primary Objective: To evaluate the efficacy of dupilumab as assessed by the reduction at Week 24 in sinus opacification on computerized tomography (CT) scan in the dupilumab group only Secondary Objectives: To evaluate the…
- Conditions
- Chronic Rhinosinusitis Without Nasal Polyps, Sinusitis, Chronic Sinusitis, Sinus Disorder
- Trial name
- Liberty CRSsNP (NCT04678856)
- Testing
- Dupilumab SAR231893
- Where
- 58 sites in United States, Argentina and 11 more
- Volunteers
- 71 people
- Sponsor
- Sanofi
Tooth Disease, Partial Edentulism
Prospective Study of NanoTite Implants Placed Into Fresh Sinus-Lift Augmentation Sites (VSSL)
This prospective, randomized-controlled, clinical study evaluates the ability of the NanoTite implant system to achieve integration and provide long-term support of a prosthesis when placed immediately in fresh sinus augmentation…
- Trial name
- NCT00713206
- Testing
- Dental Implant (Osseotite)
- Where
- Italy
- Volunteers
- 122 people
- Sponsor
- ZimVie
Atrial Fibrillation
Study on OMT-28 in Maintenance of Sinus Rhythm in Patients With Persistent Atrial Fibrillation (AF)
This is a randomized, double-blind, dose-finding, placebo-controlled, parallel group, multicenter, phase II study to evaluate the efficacy, safety, and popPK of three different doses of OMT-28 given once daily versus placebo in…
- Trial name
- PROMISE-AF (NCT03906799)
- Testing
- OMT-28
- Where
- 25 sites in Bulgaria, Czechia and 2 more
- Volunteers
- 136 people
- Sponsor
- Omeicos Therapeutics GmbH
Peripheral Arterial Disease, Arterio-venous Fistula
Serranator® Alto Post Market Clinical Follow Up (PMCF) Study
The objective of this registry is to collect observational data under local standard of care and evaluate safety and performance of the Serranator® Alto in treatment of peripheral artery disease (PAD), or dysfunctional native or…
- Conditions
- Peripheral Arterial Disease, Arterio-venous Fistula, Arteriovenous Graft
- Trial name
- NCT03538392
- Testing
- Serranator® Alto
- Sponsor
- Cagent Vascular LLC
Pulsatile Tinnitus, Venous Sinus Stenosis
BosSTENT ImpLant to trEat debilitatiNg Pulse-synchronous Tinnitus
This study is evaluating the safety and clinical performance of the BosSTENT, a new stent designed specifically for treating pulse-synchronous tinnitus due to venous sinus stenosis.
- Trial name
- B-SILENT (NCT07070089)
- Testing
- BosSTENT implantation
- Where
- 6 sites in Canada, France
- Volunteers
- 90 people
- Sponsor
- Sonorous NV, Inc
Bradycardia, Sinus Node Dysfunction
ImageReady(TM) MR Conditional Pacing System Clinical Study
The objective of the SAMURAI Clinical Study is to collect data to confirm the safety, performance and effectiveness of the ImageReady System for use in the Magnetic Resonance Imaging (MRI) environment when used in accordance with…
- Trial name
- SAMURAI (NCT01781078)
- Testing
- MRI, ImageReady System implant
- Where
- 41 sites in United States, Australia and 5 more
- Volunteers
- 363 people
- Sponsor
- Boston Scientific Corporation
Maxillary Sinusitis
A Multicenter, Randomized, Double-Blind, Double-Dummy Trial of Azithromycin SR Compared With Levofloxacin for the Treatment of Sinus Infections in Adults
The objectives of the study were to confirm that a single, 2.0-g dose of azithromycin sustained release (SR) was at least as effective to 10 days of oral levofloxacin 500 mg once a day, when used to treat adults with…
- Trial name
- NCT00643409
- Testing
- azithromycin SR (Zithromax; compound: CP-62,993), levofloxacin
- Where
- 89 sites in United States, Argentina and 11 more
- Volunteers
- 541 people
- Sponsor
- Pfizer
Chronic Sinusitis, Nasal Polyps
Steroid-Releasing S8 Sinus Implant for Recurrent Nasal Polyps
The RESOLVE Study is a randomized controlled trial with the S8 Sinus Implant in 100 chronic sinusitis patients with recurrent nasal polyps.
- Trial name
- RESOLVE (NCT01732536)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 19 sites in United States
- Volunteers
- 100 people
- Sponsor
- Intersect ENT
Nasal Polyps
Mometasone Furoate Nasal Spray for Treatment of Nasal Polyposis After Surgery (Study P03218)
This study was conducted to evaluate the effectiveness of mometasone nasal spray in preventing polyp relapse/symptom worsening in patients after surgical treatment of nasal polyps.
- Trial name
- NCT00731185
- Testing
- Mometasone Furoate Nasal Spray
- Volunteers
- 162 people
- Sponsor
- Organon and Co
End Stage Renal Disease, AV Fistula
Percutaneous Less Invasive AV Fistula for Vascular Access in ESRD
A prospective single-arm well-controlled study to evaluate the safety and effectiveness of a less invasive means of establishing vascular access to facilitate dialysis in patients with end stage renal disease.
- Conditions
- End Stage Renal Disease, AV Fistula, Fistula, End Stage Kidney Disease
- Trial name
- NCT02363972
- Testing
- Ellipsys Vascular Access Catheter
- Where
- 5 sites in United States
- Volunteers
- 103 people
- Sponsor
- Medtronic Endovascular
Ethmoid Sinusitis, Rhinosinusitis
Study to Evaluate Safety and Effectiveness of AdvaCoat Sinus Gel
The purpose of this study is to evaluate the safety and effectiveness of AdvaCoat® sinus gel, a nasal/sinus dressing, for adhesion prevention following endoscopic ethmoid sinus surgery.
- Trial name
- NCT00554190
- Testing
- AdvaCoat sinus gel, Merogel Injectable
- Where
- 4 sites in United States
- Volunteers
- 29 people
- Sponsor
- Carbylan Therapeutics, Inc.
Paroxysmal Atrial Fibrillation
Flecainide Acetate Inhalation Solution for Cardioversion of Recent-Onset, Symptomatic Atrial Fibrillation
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled clinical study designed to evaluate the efficacy and safety of FlecIH-103 (flecainide acetate inhalation solution) compared with placebo in patients…
- Trial name
- RESTORE-1 (NCT05039359)
- Testing
- FlecIH-103
- Where
- 40 sites in United States, Czechia and 4 more
- Volunteers
- 54 people
- Sponsor
- InCarda Therapeutics, Inc.
Complex Perianal Fistula, Crohn Disease
Safety and Efficacy of Adipose-Derived Stem Cells to Treat Complex Perianal Fistulas Patients With Crohn's Disease
The purpose of this study is to determine safety and efficacy of eASCs (expanded adult stem cells) for treatment of complex perianal fistulas in patients with Crohn's disease.
- Trial name
- FATT (NCT01378390)
- Testing
- Expanded autologous adipose-derived adult stem cells (eASCs)
- Where
- 12 sites in Austria, Netherlands and 1 more
- Volunteers
- 56 people
- Sponsor
- Tigenix S.A.U.
Venous Stenosis, Venous Occlusion
WRAP North America
The goal of this observational study is to investigate the safety and efficacy of the WRAPSODY CIE in a real-world North American population.
- Trial name
- NCT06807099
- Testing
- Merit WRAPSODY® Cell Impermeable Endoprosthesis (WRAPSODY CIE)
- Where
- 16 sites in United States, Canada
- Volunteers
- 250 people
- Sponsor
- Merit Medical Systems, Inc.
Atrial Fibrillation
Effects of Intravenous K201 on the Restoration of Sinus Rhythm in Subjects With Symptomatic Atrial Fibrillation
The purpose of this study is to evaluate the effects of a single intravenous infusion of K201 compared to placebo in a dose escalating manner on conversion to sinus rhythm, reduction of subject's symptom score, and safety.
- Trial name
- TUNDRA-AF (NCT01259622)
- Testing
- saline, K201
- Where
- 17 sites in Denmark, Israel
- Volunteers
- 80 people
- Sponsor
- Sequel Pharmaceuticals, Inc
Vesico-vaginal Fistula
Clinical Evaluation of the Surgisis Biodesign Vesico-Vaginal Fistula Plug
This clinical trial will study the safety and effectiveness of the Biodesign Vesico-vaginal fistula plug in the treatment of vesico-vaginal fistulas resulting from childbirth trauma.
- Trial name
- VVP (NCT00923338)
- Testing
- Surgisis Biodesign (Vesico-vaginal fistula plug)
- Where
- Uganda
- Volunteers
- 20 people
- Sponsor
- Cook Group Incorporated
STEMI - ST Elevation Myocardial Infarction
Semi Occlusion of the Coronary Sinus as an Adjunct to PCI in STEMI Patients, FIH Clinical Study
The present study is planned to evaluate the safety and feasibility of the Booster Balloon catheter when applied to STEMI patients.
- Trial name
- NCT05557019
- Testing
- Booster Balloon Catheter
- Where
- 2 sites in Georgia, Israel
- Volunteers
- 20 people
- Sponsor
- Intratech Medical Ltd.
Crohn Disease, Rectal Fistula
A Study Using Artificial Intelligence to Identify Adults With Complex Perianal Fistulas Associated With Crohn's Disease
Natural Language Processing and machine learning are examples of artificial intelligence tools. This study will check if these tools correctly identify people with Crohn's disease with complex perianal fistulas from their medical…
- Trial name
- INTUITION-CPF (NCT04844593)
- Where
- 3 sites in Spain
- Volunteers
- 32 people
- Sponsor
- Takeda
Cancer
Fentanyl Sublingual Spray in Treating Patients With Breakthrough Cancer Pain
This is a phase III, randomized, double-blind, placebo-controlled, multicenter study of the clinical response to fentanyl sublingual spray as a treatment for breakthrough cancer pain.
- Trial name
- NCT00538850
- Testing
- Fentanyl sublingual spray
- Where
- United States
- Volunteers
- 130 people
- Sponsor
- INSYS Therapeutics Inc