Clinical trials: Sinus Endoscopic Surgery
Sinusitis
PerClot to Control Bleeding in Endoscopic Sinus Surgery
A prospective, single centre, single arm study designed to collect clinical data on PerClot when used in subjects undergoing endoscopic sinus surgery.
- Trial name
- NCT02221128
- Where
- United Kingdom
- Volunteers
- 12 people
- Sponsor
- CryoLife Europa
Wound Healing
Efficacy and Safety of the Investigational Device, SurgiShield Anti-Adhesion Barrier Gel
This clinical trial is intended to evaluate the impact, efficacy, and safety of Chitosan formulated adhesion inhibitor, SurgiShield when used in the process of wound healing after endoscopic sinus surgery.
- Trial name
- NCT01895933
- Testing
- 5ml surgishield
- Where
- 2 sites in South Korea
- Volunteers
- 33 people
- Sponsor
- D.med
Sinus Endoscopic Surgery, Turbinate
Safety and Effectiveness of TurbAlign™ for Middle Turbinate Medialization After Functional Endoscopic Sinus Surgery
A study of a bioabsorbable implant to separate the middle turbinate from the lateral nasal wall associated with nasal/sinus surgery
- Trial name
- Gaia (NCT07027267)
- Testing
- Implantation of Spirair device into the middle turbinates, TurbAlign
- Where
- 5 sites in United States
- Volunteers
- 50 people
- Sponsor
- Spirair, Inc
Chronic Rhinosinusitis (Diagnosis)
The Effect of Intra-sinus Application of Betamethasone Dipropionate Nasal Cream on Patients with Chronic Rhinosinusitis Post Functional Endoscopic Sinus Surgery (FESS)
To assess the safety and efficacy of one (single) application of Betamethasone Dipropionate Nasal Cream (BMDP CREAM) onto the sinus mucosa.
- Trial name
- NCT05882903
- Testing
- Betamethasone Dipropionate Nasal Cream 0.0644%, Pre-filled syringe and applicator device
- Where
- 4 sites in Australia
- Volunteers
- 24 people
- Sponsor
- Oticara Australia PTY LTD
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
Sinusitis, Maxillary Sinusitis
Study Designed to Clinically Evaluate Sinus Wash Device Prototypes
The purpose of this study is to clinically evaluate sinus wash device prototypes in patients with sinusitis during Endoscopic Sinus Surgery (ESS) and in the hospital outpatient
- Trial name
- NCT02931604
- Testing
- SinuSafe Medical Device for Maxillary Sinus
- Volunteers
- 50 people
- Sponsor
- SinuSafe Medical LTD
Rhinosinusitis, Sinusitis
Clinical Outcomes and Patient Satisfaction With Velnez Versus Nasopore in Nasal Surgery
This clinical trial evaluated two absorbable nasal packing materials - VELNEZ and NASOPORE - in adult patients (18-70 years) who underwent nasal surgery, including septoplasty, FESS, or turbinoplasty.
- Conditions
- Rhinosinusitis, Sinusitis, Chronic Rhino-sinusitis
- Trial name
- NCT07560254
- Testing
- VELNEZ Nasal Pack, NASOPORE Nasal Pack
- Where
- Malaysia
- Volunteers
- 20 people
- Sponsor
- Ayu, Inc.
Chronic Sinusitis
A Clinical Evaluation of the Sinexus Intranasal Splint Following Functional Endoscopic Sinus Surgery in Patients With Chronic Rhinosinusitis
The purpose of this study is to assess the safety and performance of the Sinexus Intranasal Splint when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Rhinosinusitis.
- Trial name
- CONSENSUS II (NCT00840970)
- Testing
- non-coated Intranasal Splint, Sinexus Intranasal Splint
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Chronic Sinusitis
Clinical Evaluation of Propel Nova Sinus Implant in Peripheral Sinus Ostia
This is a feasibility study is to assess the performance, safety and initial signals of efficacy of the drug-eluting Propel Nova Sinus Implant when used in chronic sinusitis patients undergoing sinus surgery of peripheral sinus…
- Trial name
- EXCEED (NCT02228720)
- Testing
- Propel Nova Sinus Implant
- Where
- 2 sites in United States
- Volunteers
- 15 people
- Sponsor
- Intersect ENT
Chronic Rhinosinusitis
Canadian Health Economics, Outcome, and Effectiveness Comparison of Treatment in Patients With Chronic Rhinosinusitis
The economic, patient related outcome, and effectiveness of balloon sinuplasty in the treatment of CRS patients with frontal and other sinus disease in the Canadian healthcare environment is not known at this time.
- Trial name
- CHEC (NCT01455948)
- Testing
- Relieva Balloon Sinuplasty™ System, Functional Endoscopic Sinus Surgery
- Where
- 8 sites in Canada
- Volunteers
- 25 people
- Sponsor
- Integra LifeSciences Corporation
Sinusitis, Tissue Adhesion, Surgery-Induced
Efficacy and Safety for Medicurtain® in Prevention of Adhesion After Endoscopic Sinus Surgery (Pivotal Study)
This clinical trial is to prove that the treatment group of Medicurtain® is non-inferior to the treatment group of Guardix-sol®, test equipment on adhesion after endoscopic sinus surgery, upon the aspects of adhesion prevention…
- Trial name
- NCT05049434
- Testing
- Medicurtain®, GUARDIX-SG®
- Where
- South Korea
- Volunteers
- 77 people
- Sponsor
- Shin Poong Pharmaceutical Co. Ltd.
Sinusitis Chronic
GLS-1200 Topical Nasal Spray to Prevent Sinusitis After Endoscopic Sinus Surgery
This clinical trial will evaluate the safety, tolerability and effectiveness of GLS-1200 nasal spray in addition to the standard of care after endoscopic sinus surgery in people with chronic sinusitis.
- Trial name
- NCT04060316
- Testing
- GLS-1200
- Where
- United States
- Volunteers
- 99 people
- Sponsor
- GeneOne Life Science, Inc.
Chronic Sinusitis, Nasal Polyposis
S8 Sinus Implant in Chronic Sinusitis Patients With Recurrent Nasal Polyps
The RESOLVE II Study is a randomized, single-blind, parallel arm, concurrently controlled, multicenter study with 300 chronic sinusitis patients who had prior endoscopic sinus surgery but present with recurrent sinus obstruction.
- Trial name
- RESOLVE_II (NCT02291549)
- Testing
- S8 Sinus Implant, Mometasone furoate nasal spray
- Where
- 40 sites in United States
- Volunteers
- 300 people
- Sponsor
- Intersect ENT
Chronic Rhinosinusitis (CRS) With and Without Nasal Polyps
Paclitaxel-Coated Balloon Treatment of Chronic Rhinosinusitis
This is a prospective, multicenter, randomized, controlled, double-blind clinical trial enrolling 300 adult subjects with chronic rhinosinusitis (CRS) with and without nasal polyps (CRSwNP and CRSsNP) indicated for endoscopic…
- Trial name
- RESTORE-2 RCT (NCT07290140)
- Testing
- Airiver ESSpand DCB, ESS
- Where
- 10 sites in United States
- Volunteers
- 300 people
- Sponsor
- Airiver Medical, Inc.
Chronic Sinusitis
Clinical Evaluation of the Steroid-Eluting Sinexus Intranasal Splint When Used Following Functional Endoscopic Sinus Surgery (FESS) in Patients With Chronic Sinusitis
This study allows continued access to the Sinexus Intranasal Splint while a marketing application is being prepared. This study will generate additional performance, reimbursement and safety data for the steroid-eluting Sinexus…
- Trial name
- NCT00912405
- Testing
- Steroid-Eluting Sinexus Intranasal Splint
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Intersect ENT
Endoscopic Sinus Surgery
The Effect of Dexmedetomidine, Melatonin and Pregabalin
Various drugs have been used for the purpose: nitroglycerine, sodium nitroprusside, propofol, beta blockers, calcium channel blockers, higher concentrations of inhalational anesthetics etc.
- Trial name
- NCT05829148
- Testing
- Dexmedetomidine, Melatonin, Pregabalin
- Where
- Egypt
- Volunteers
- 120 people
- Sponsor
- Egymedicalpedia
Chronic Sinusitis
A Clinical Evaluation of a Steroid-Coated Sinus Stent When Used Following Functional Endoscopic Sinus Surgery in Patients With Chronic Sinusitis
The purpose of this study is to assess the safety and efficacy of the Propel mometasone furoate implant when used following Functional Endoscopic Sinus Surgery (FESS) in patients with Chronic Sinusitis (CS).
- Trial name
- ADVANCE II (NCT01253577)
- Testing
- Sinus Stent with drug coating, Non Coated Sinus Stent
- Where
- 11 sites in United States
- Volunteers
- 105 people
- Sponsor
- Intersect ENT
Sinusitis
Hemostatic Matrix in Endoscopic Sinus Surgery
Evaluating clinical performance of Hemostatic Matrix with bovine thrombin in achieving hemostasis in patients undergoing endoscopic sinus surgery.
- Trial name
- NCT00242437
- Testing
- Hemostatic matrix, bovine thrombin
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Ethicon, Inc.
Synechia
A Prospective, Randomized, Multi-Center Evaluation of MediENT® Middle Turbinate Implant Versus MeroPack®, a Bioresorbable Nasal Dressing / Sinus Stent After Endoscopic Sinus Surgery
The purpose of this study is to compare the safety and effectiveness of MediENT to MeroPack after FESS.
- Trial name
- MISTY (NCT01733667)
- Testing
- MediENT, MeroPack
- Where
- 5 sites in United States
- Volunteers
- 60 people
- Sponsor
- ENTrigue Surgical, Inc.
Rhinosinusitis
Healthcare Utilization and Outcomes of FinESS Treatment in the Office
A prospective, nonrandomized trial to evaluate postoperative healthcare resource utilization after maxillary balloon antrostomy using FinESS Sinus Treatment in the physician's office.
- Trial name
- RELIEF (NCT00986830)
- Testing
- FinESS Sinus Treatment
- Where
- 13 sites in United States
- Volunteers
- 74 people
- Sponsor
- Entellus Medical, Inc.