Clinical trials: Nasal Surgery
Diagnostic, Procedures and Surgeries on or Through Accessible Mucous Membranes
Topical Application of Cocaine HCl 4% and 10% on Safety and Efficacy in Local (Topical) Anesthesia
This study aims to evaluate topical application of Cocaine HCl 4% and 10% on safety and efficacy in local (topical) anesthesia for diagnostic procedures and surgeries on or through accessible mucous membranes of the nasal…
- Conditions
- Diagnostic, Procedures and Surgeries on or Through Accessible Mucous Membranes, of the Nasal Cavities
- Trial name
- NCT01746940
- Testing
- Cocaine HCl 4% Topical Solution, Cocaine HCl 10% Topical Solution
- Where
- 2 sites in United States
- Volunteers
- 159 people, healthy volunteers welcome
- Sponsor
- Lannett Company, Inc.
Nasal Disease, Nasal Surgery
Medical Device Pivotal Study to Injection With SkinPlus-HYAL Implant Lidocaine vs RESTYLANE Lidocaine in of Nasolabial Folds
Purpose : This investigation intends to demonstrate that the investigational device, SkinPlus-HYAL Implant Lidocaine, is non-inferior to the comparator device, RESTYLANE Lidocaine, in terms of temporary wrinkle reduction effect…
- Trial name
- BPLUS-02 (NCT06305520)
- Testing
- Investigational medical device (SkinPlus-HYAL Implant Lidocaine), Active Comparator: Active Comparator Medical Device (RESTYLANE Lidocaine)
- Where
- South Korea
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Bioplus
Rhinosinusitis Chronic, Wound Healing
Evaluation of the Safety and Performance of a Bioresorbable Nasal Dressing Containing Mometasone Furoate
The objective of this study is to investigate the safety and performance of OCEAN® as an adjunct in wound healing after nasal/sinus surgery by using OCEAN® in patients undergoing nasal/sinus surgery.
- Conditions
- Rhinosinusitis Chronic, Wound Healing, Sinus Surgery, Mometasone Furoate
- Trial name
- ENHANCE (NCT06642116)
- Testing
- OCEAN
- Where
- 3 sites in United States
- Volunteers
- 10 people
- Sponsor
- Polyganics BV
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.
Polyp of Ethmoidal Sinus, Surgery
RESPIMER® Netiflow® vs. Saline Solutions During Nasal Irrigation Following Bilateral Ethmoidectomy (Nasal Polyposis)
The main objective of this study is to compare the effects of RESPIMER® NetiFlow® solution and device versus saline solution (0.9% NaCl), the standard treatment, used with RESPIMER® NetiFlow® device, both used postoperative care…
- Trial name
- NETIFLOW (NCT02559284)
- Testing
- A postoperative care after ethmoid sinus surgery
- Where
- 8 sites in France
- Volunteers
- 189 people
- Sponsor
- Laboratoire de la Mer
Surgical Site Infections, Surgical Wound Infection
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections
This is a Phase 3 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major…
- Conditions
- Surgical Site Infections, Surgical Wound Infection, Infections, Anti-Infective Agents
- Trial name
- LANTERN (NCT06702878)
- Testing
- nasal antimicrobial photodisinfection therapy
- Where
- 14 sites in United States
- Volunteers
- 4,787 people
- Sponsor
- Ondine Biomedical Inc.
Chronic Rhinosinusitis With Nasal Polyposis
Study in Adults With Severe Chronic Rhinosinusitis With Nasal Polyposis Treated With Dupilumab in France
This is a multicentre, non-interventional, single arm study that aims to describe the treatment patterns in France: patients' characteristics, disease characteristics, prior treatments for Severe chronic rhinosinusitis with nasal…
- Trial name
- OPALE (NCT06393946)
- Testing
- Dupilumab
- Where
- France
- Volunteers
- 150 people
- Sponsor
- Sanofi
Epistaxis
Trial of a Novel Chitosan Hemostatic Sealant in the Management of Complicated Epistaxis
Purpose: This study is a prospective clinical trial to investigate the efficacy of a chitosan-coated nasal packing (ChitoFlex® used in conjunction with the HemCon Nasal Plug) in the management of difficult spontaneous epistaxis…
- Trial name
- NCT00863356
- Testing
- 2009-I-Epistaxis-1
- Where
- United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- HemCon Medical Technologies, Inc
ENT Disorder, Nasal Procedures
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or…
- Conditions
- ENT Disorder, Nasal Procedures, Nasal Anesthesia, Nasal Mucosa Surgery
- Trial name
- NCT04792034
- Testing
- Cocaine Hydrochloride Nasal Solution
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- LXO Ireland
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
Staphylococcal Infections, Surgical Site Infection
Effect of Exeporfinium Chloride (XF-73) Gel on Nasal S.Aureus in Patients at Risk of Post-op Staphylococcal Infection
This study looks at the difference between XF-73 and placebo in reducing the carriage of a bacteria S. aureus in the nose before, during and after heart surgery.
- Trial name
- NCT03915470
- Testing
- XF-73
- Where
- 21 sites in United States, Georgia and 1 more
- Volunteers
- 124 people
- Sponsor
- Destiny Pharma Plc
URTI, Bronchiolitis
Assessement of Effectiveness of Seawater Nasal Sprays on Sinonasal Symptoms
The purpose of this post-market clinical investigation is to assess in a real-life setting, the effectiveness, usage, tolerance, safety and satisfaction of 4 isotonic and hypertonic seawater-based CE-marked nasal sprays.
- Conditions
- URTI, Bronchiolitis, COVID - 19, Allergic Rhinitis
- Trial name
- SeaBridge (NCT07262450)
- Testing
- Respimer® Hygiene-Prevention -Baby, kids, adults, Respimer® Hygiene-Prevention Kids, adults, Respimer® Decongestion Baby, kids, adults
- Where
- 32 sites in France
- Volunteers
- 1,065 people
- Sponsor
- Laboratoire de la Mer
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.
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.
Surgical Site Infections, Infections
Light-Activated Antimicrobial Therapy to Prevent Surgical Site Infections - Canada
This is a Phase 4 multi-center, group-randomized, crossover trial to compare nasal antimicrobial photodisinfection therapy (aPDT) with standard of care for prevention of surgical site infections in patients undergoing major…
- Conditions
- Surgical Site Infections, Infections, Surgical Wound Infections, Anti-Infective Agents
- Trial name
- LANTERN (NCT07189858)
- Testing
- Nasal antimicrobial photodisinfection therapy
- Where
- 4 sites in Canada
- Volunteers
- 401 people
- Sponsor
- Ondine Biomedical Inc.
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
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.
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.
Surgical Site Infection
Prevention of Surgical Site Infections: Effectiveness of Nasal Povidone-Iodine and Nasal Mupirocin
We hypothesize the application of mupirocin or povidone-iodine to the nares is equally effective in short term Staphylococcus aureus(SA)suppression.
- Trial name
- NCT01313182
- Testing
- mupirocin calcium ointment, 2%, 3M Skin and Nasal Antiseptic
- Where
- United States
- Volunteers
- 1,874 people
- Sponsor
- Solventum US LLC
Open Angle Glaucoma
Minimally Invasive Nasal Trabeculostomy: Long-Term Follow-Up Extension Study
This study is a follow-up extension study conducted in continuation of the prior MINT study (MMS-EEU-4), in which the long-term (i.e., 18, 24 months) clinical outcomes of Minimally Invasive Nasal Trabeculostomy (MINT) will be…
- Trial name
- NCT06612346
- Testing
- Minimally Invasive Micro Trabeculostomy
- Where
- Armenia
- Volunteers
- 36 people
- Sponsor
- Sanoculis Ltd