Clinical trials: Sinus Surgery
Sinusitis
Rates of Middle Meatus Synechiae Formation Post ESS
The study is designed to evaluate if addition of the steroid to the spacer / stent will improve healing after endoscopic sinus surgery (ESS) compared to spacer without drug.
- Trial name
- NCT03036735
- Testing
- steroid eluting spacer
- Volunteers
- 10 people
- Sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
Chronic Sinusitis, Nasal Obstruction
Effect of Tranexamic Acid on Postoperative Bleeding Following Sinus and Nasal Surgery
The purpose of the research is to assess the effectiveness of a dose of intravenous tranexamic acid (TXA) given intraoperatively to reduce postoperative bleeding after endoscopic sinus or nasal surgery (e.g.
- Conditions
- Chronic Sinusitis, Nasal Obstruction, Turbinate; Hypertrophy Mucous Membrane, Deviated Nasal Septum - Congenital
- Trial name
- NCT04754230
- Testing
- Tranexamic Acid 1,000 Mg/10 mL (100 Mg/mL) INTRAVEN VIAL (ML)
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University
Post-operative Pain, Sinus Surgery
Postoperative Pain Control in Septum and Sinus Surgery
This study will evaluate if the use of acetaminophen round the clock (scheduled doses) will lead to less opiate use in the first week post-operative (after surgery) in sinus/septum surgery patients.
- Trial name
- NCT04149964
- Testing
- Acetaminophen 325 mg Oral Tablet, Acetaminophen 650 mg Oral Tablet, OxyCODONE 5 mg Oral Tablet
- Where
- United States
- Volunteers
- 65 people
- Sponsor
- Corewell Health East
Strabismus, Reflex, Oculocardiac
Hydroxyzine Dihydrochloride Premedication is a Necessity for Strabismus Surgery
Oculocardiac reflex (OCR) is usually happening in pediatric strabismus surgery and observed just when the surgent pulls the ocular muscles.
- Conditions
- Strabismus, Reflex, Oculocardiac, Hydroxyzine, Bradycardia Sinus
- Trial name
- NCT03806270
- Testing
- Midazolam, Hydroxyzine Dihydrochloride
- Where
- 2 sites in Turkey (Türkiye)
- Volunteers
- 45 people
- Sponsor
- Yeditepe University
Paranasal Sinus Disease
Effectiveness of Antibiotic Delivery Via Bio-absorbable Sponge
This study will evaluate the efficacy of a nasopore sponge dressing soaked in Bacitracin VS a sponge soaked in Saline / and the administration of oral antibiotics.
- Trial name
- NCT01222832
- Testing
- Bacitracin
- Where
- United States
- Volunteers
- 226 people
- Sponsor
- Steward St. Elizabeth's Medical Center of Boston, Inc.
Intraoperative Bleeding
Effects of Adrenaline Infiltration on Surgical Field of View in Endoscopic Sinus Surgery
In endoscopic sinus surgery a clear surgical field of view is a very important aspect for good surgical outcome. This study is to evaluate the preoperative preparation to acquire best surgical field of view by comparing between…
- Trial name
- NCT05867342
- Testing
- Epinephrin, 1% lidocaine with epinephrin 1:100,000, Saline
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Stanford University
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 Rhinosinusitis
Total Intravenous Anesthesia (TIVA) vs. Inhaled Anesthesia for Endoscopic Sinus Surgery.
The purpose of this study is to compare total intravenous anesthesia to inhaled anesthesia in endoscopic sinus surgery for chronic sinusitis.
- Trial name
- NCT01214057
- Testing
- Propofol and Remifentanyl, Sevoflurane and Remifentanyl
- Where
- United States
- Volunteers
- 23 people
- Sponsor
- The University of Texas Health Science Center, Houston
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
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
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, Opioid Use
Pain Control Following Sinus Surgery
Given the ongoing national opioid epidemic, an increased interest has developed in optimizing opioid prescribing practices of physicians, including otolaryngologists.
- Conditions
- Sinusitis, Opioid Use, Opioid Abuse, Narcotic Use
- Trial name
- NCT03783702
- Testing
- OxyCODONE 5 Mg (milligram) Oral Tablet, Ibuprofen 600 Mg (milligram) Oral Tablet, Acetaminophen 650 MG (milligram) Oral Tablet
- Where
- 6 sites in United States, Canada
- Volunteers
- 118 people
- Sponsor
- Stanford University
Pilonidal Sinus, Sinus; Dermal, Pilonidal
Conservative Versus Surgical Treatment of Umbilical Pilonidal Disease
The aim of the study was to compare the results of conservative and surgical treatment, to create an algorithm for the management of the disease, and gain more information about the etiology, pathogenesis, and course of the…
- Conditions
- Pilonidal Sinus, Sinus; Dermal, Pilonidal, Umbilical Granuloma
- Trial name
- NCT01662765
- Testing
- Surgery, conservative
- Where
- 5 sites in Turkey (Türkiye)
- Volunteers
- 84 people
- Sponsor
- Medical Park Gaziantep Hospital
Chronic Sinusitis, Ethmoidal
The PIO II Study: In-office Post-op Placement of a Steroid-eluting Sinus Implant
Randomized, controlled, blinded clinical trial with 40 patients randomized in a 1:1 ratio to either treatment (bilateral in-office placement of a drug-eluting implant in the ethmoid sinuses following ethmoidectomy) or control…
- Trial name
- NCT02668302
- Testing
- Steroid-eluting sinus implant, Post-op standard of care
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Collin County Ear Nose & Throat
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
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
Postoperative Pain
Efficacy of Oral vs. Intravenous Acetaminophen
The comparative efficacy of intravenous (IV) to oral (PO-'per os') acetaminophen in the management of postoperative pain is understudied and largely unknown.
- Trial name
- NCT02643394
- Testing
- Oral Acetaminophen, Intravenous acetaminophen
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- University of Texas Southwestern Medical Center
Sinusitis, Nasal Polyps
Comparison of Nasal Steroids After FESS in CRSwNP
The purpose of this study is to compare intranasal fluticasone spray with budesonide nasal saline rinses in both the upright and head forward positions in patients who have had functional endoscopic sinus surgery (FESS) for…
- Trial name
- NCT02194062
- Testing
- fluticasone nasal spray, Budesonide head upright, Budesonide head forward
- Where
- 2 sites in United States
- Volunteers
- 32 people
- Sponsor
- Yale University
Pain, Postoperative
Postoperative Pain and Functional Patient Outcomes After Functional Endoscopic Sinus Surgery
The aim of the study is to quantify postoperative pain after functional endoscopic sinus surgery (FESS) and investigate whether preemptive analgesia may positively impact intraoperative anesthetic management, decrease patient…
- Trial name
- NCT00927888
- Testing
- Bupivacaine Block
- Where
- United States
- Volunteers
- 56 people
- Sponsor
- Stanford University
Sinusitis
Rates of Middle Meatus Synechiae Formation Post Endoscopic Sinus Surgery
Endoscopic sinus surgery (ESS) is the gold standard surgical intervention for chronic rhinosinusitis that is not adequately controlled with maximal medical therapy.
- Trial name
- NCT02627794
- Testing
- Restora™ Steroid eluting spacer, Silastic Silicone Spacer
- Where
- United States
- Volunteers
- 3 people
- Sponsor
- Cedars-Sinai Medical Center