Clinical trials: Sinus Surgery
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
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
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
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
Efficacy of Post-FESS Implantation of Composite Removable Sinus Stent to Prevent Post-Operative Complications
This is a randomized controlled first in man study. Study purpose is to assess safety and efficacy of Composite Removable Stent Composite Stent implantation post-endoscopic sinus surgery in terms of: Sinus tissue adhesions Middle…
- Trial name
- NCT02812199
- Testing
- Composite Removable Sinus Stent, adrenaline-lidocaine, cold saline wash
- Where
- Israel
- Volunteers
- 30 people
- Sponsor
- STS Medical
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
Chronic Sinusitis
Efficacy of Seprapack Sinus Dressing Versus No Dressing in the Prevention of Intranasal Adhesions Following Sinus Surgery
The purpose of this study is to investigate if the space occupying effect of Seprapack will lead to a reduction in post operative adhesions and more healing of the sinus cavity when compared to the use of no packing material.
- Trial name
- NCT00140608
- Testing
- Seprapack Sinus Dressing
- Where
- 3 sites in United States
- Sponsor
- Genzyme, a Sanofi Company
Chronic Sinusitis
Safety and Performance of the Steroid-Releasing S8 Sinus Implant
The purpose of this study was to assess the safety and performance of the steroid-releasing S8 Sinus Implant when used in post-sinus surgery patients who presented with recurrent sinus obstruction.
- Trial name
- S8PK (NCT01894503)
- Testing
- S8 Sinus Implant (mometasone furoate, 1350 mcg)
- Where
- United States
- Volunteers
- 5 people
- Sponsor
- Intersect ENT
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.
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.
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
Anal Fistula
Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive…
- Trial name
- NCT00115466
- Testing
- Non-surgical autologous implant of ASCs
- Where
- Spain
- Volunteers
- 50 people
- Sponsor
- Cellerix
Arteriovenous Fistula
An Efficacy and Safety Study of SRM003 in the Treatment of Subjects Undergoing Creation of an Arteriovenous Fistula to Facilitate Hemodialysis Access
A study to evaluate the efficacy of SRM003 treatment versus participating sites' standard practice treatment in improving the rate of AVF maturation and use in subjects with end-stage renal disease undergoing surgery for creation…
- Trial name
- NCT01806545
- Testing
- SRM003, Participating Site's standard practice
- Where
- 47 sites in United States
- Volunteers
- 64 people
- Sponsor
- Shire
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
Complication of Renal Dialysis, End Stage Renal Disease
A Study Testing the Use of a Perivascular Sirolimus Formulation (Sirogen) in ESRD Patients Undergoing AV Fistula Surgery
The primary study objective is to evaluate the benefit of the Sirolimus eluting Collagen implant (SeCI; Sirogen), a single dose prophylactic treatment delivered intraoperatively at the time of surgical creation of an…
- Conditions
- Complication of Renal Dialysis, End Stage Renal Disease, End Stage Kidney Disease, ESRD
- Trial name
- ACCESS2 (NCT05425056)
- Testing
- Sirolimus
- Where
- 22 sites in United States, United Kingdom
- Volunteers
- 136 people
- Sponsor
- Vascular Therapies, Inc.