Clinical trials: Distension
Coronary Heart Disease
A Study Assessing the Effect of RO4607381 on Vascular Function in Patients With Coronary Heart Disease (CHD) or CHD-Risk Equivalent Patients
This study will assess the safety, tolerability and efficacy of RO4607381 in patients with coronary heart disease (CHD) or CHD risk equivalents.
- Trial name
- NCT00655538
- Testing
- dalcetrapib
- Where
- 23 sites in Austria, France and 5 more
- Volunteers
- 476 people
- Sponsor
- Hoffmann-La Roche
Coronary Artery Disease
Evaluation of Coronary Luminal Diameter Enlargement With Emerge™ 1.20 mm PTCA Dilatation Catheter
To evaluate the acute safety and device procedural success of the Emerge 1.20 mm PTCA dilatation catheter when used as a pre-dilatation device in the stenotic portion of coronary arteries or bypass grafts.
- Trial name
- NCT01635881
- Testing
- Emerge™ 1.20 mm PTCA Dilatation Catheter
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Boston Scientific Corporation
Mydriasis
Safety and Efficacy of Phenylephrine 2.5%-Tropicamide 1% Microdose Ophthalmic Solution for Pupil Dilation
This study evaluated pupil dilation after administration of fixed combination tropicamide-phenylephrine (TR/PH) vs. placebo. Participants attended 3 visits.
- Trial name
- MIST-2 (NCT03751098)
- Testing
- Tropicamide/Phenylephrine ophthalmic solution (TR/PE)
- Where
- 2 sites in United States
- Volunteers
- 76 people, healthy volunteers welcome
- Sponsor
- Eyenovia Inc.
Healthy
Efficacy of Brooke Bond Black Tea Extract on Flow Mediated Dilation in Indian Males
This study examines the effect of 1800 mg/day standardized Brooke Bond black tea extract, equivalent to 400 mg flavonoids, on Flow Mediated Dilation in healthy Indian males.
- Trial name
- NCT01561300
- Testing
- Nutrition intervention study with a black tea extract, Nutrition intervention study with a control
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Unilever R&D
Benign Prostatic Hyperplasia, Benign Prostatic Hypertrophy
Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter
A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.
- Trial name
- EVEREST-I (NCT03423979)
- Testing
- Optilume™ BPH Prostatic DCB Dilation Catheter, Paclitaxel
- Where
- 5 sites in Dominican Republic, Panama
- Volunteers
- 80 people
- Sponsor
- Urotronic Inc.
Sinusitis
Optimization and Refinement of Technique in In-Office Sinus Dilation 2
A prospective, multi-arm, multi-center, observational post-market study of balloon sinus dilatation in the physician office setting under local anesthesia to treat patients with chronic rhinosinusitis (CRS).
- Trial name
- ORIOS 2 (NCT01107379)
- Testing
- Relieva Balloon Sinuplasty System
- Where
- 3 sites in United States
- Volunteers
- 203 people
- Sponsor
- Integra LifeSciences Corporation
Keratoconus, Post-Refractive Ectasia
Corneal Crosslinking in Patients With Keratoconus and Post-Refractive Ectasia
The purpose of this study is to evaluate the effectiveness of using riboflavin and UV light to treat progressive keratoconus or post-refractive corneal ectasia.
- Trial name
- NCT01143389
- Testing
- Riboflavin, UVX light
- Where
- United States
- Volunteers
- 510 people
- Sponsor
- Price Vision Group
Mydriasis, Dilation
Safety and Efficacy of Nyxol (0.75% Phentolamine Ophthalmic Solution) to Reverse Pharmacologically-Induced Mydriasis
The objectives of this study are: To evaluate the efficacy of Nyxol to expedite the reversal of pharmacologically-induced mydriasis across multiple mydriatic agents with an emphasis on phenylephrine To evaluate the efficacy of…
- Trial name
- NCT04620213
- Testing
- Phentolamine Ophthalmic Solution 0.75%
- Where
- 12 sites in United States
- Volunteers
- 185 people, healthy volunteers welcome
- Sponsor
- Opus Genetics, Inc
Sinusitis
Medical Therapy Versus Balloon Sinus Dilation for Patients With Chronic Rhinosinusitis
This post-market study aims to compare health outcomes for Chronic Rhinosinusitis (CRS) patients treated with balloon sinus dilation (BSD) versus continued medical management.
- Trial name
- MERLOT (NCT01685229)
- Testing
- Balloon sinus dilation, Medical Management
- Where
- 20 sites in United States
- Volunteers
- 198 people
- Sponsor
- Integra LifeSciences Corporation
Sinusitis
Sinus Balloon Dilation in Pediatric Patients
Safety and effectiveness of sinus balloon dilation in patients 2-21 years old.
- Trial name
- NCT02278484
- Testing
- XprESS device and PathAssist confirmation tools
- Where
- 4 sites in United States
- Volunteers
- 50 people
- Sponsor
- Entellus Medical, Inc.
Ischemic Heart Disease, Coronary Artery Stenosis
A Clinical Evaluation of the MINI TREK RX 1.20 mm Coronary Dilatation Catheter in Stenotic Lesions
This is a prospective, single-arm, open-label, multi-center, observational study to assess the acute safety and efficacy of MINI TREK RX 1.20 mm for enlarging coronary luminal diameter during percutaneous coronary intervention…
- Conditions
- Ischemic Heart Disease, Coronary Artery Stenosis, Chronic Coronary Total Occlusion, Coronary Bypass Graft Stenosis
- Trial name
- CROSS (NCT01186198)
- Testing
- MINI TREK RX 1.20 mm Coronary Dilatation Catheter
- Where
- 4 sites in United States
- Volunteers
- 71 people
- Sponsor
- Abbott Medical Devices
Chronic Sinusitis, Chronic Rhinosinusitis (Diagnosis)
XprESS Maxillary Balloon Dilation Study
A prospective, single-arm, post approval pilot study.
- Trial name
- NCT01525862
- Testing
- Balloon sinus dilation
- Where
- 2 sites in United States
- Volunteers
- 21 people
- Sponsor
- Entellus Medical, Inc.
Vascular Function
Effect of Black Tea on Vascular Function
Epidemiological studies indicate that regular consumption of three cups of black tea per day reduces the risk of stroke or myocardial infarction.
- Trial name
- Heraclitus (NCT01945970)
- Testing
- Black tea extract, Positive control
- Where
- Italy
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Unilever R&D
Mydriasis
Safety and Efficacy of Fixed Combination Phenylephrine-Tropicamide for Pupil Dilation
Subjects will receive ½ of the approved dose of MydCombi to determine the dilation curve with the reduced dose.
- Trial name
- NCT06217796
- Testing
- MydCombi
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Eyenovia Inc.
Ectasia
Safety Study of the VEGA UV-A System to Treat Ectasia
The purpose of this research study is to test the safety, tolerability, and effectiveness of corneal collagen cross-linking (CXL) when used to treat ectasia.
- Trial name
- NCT01398839
- Testing
- VEGA UV-A Illumination System, Riboflavin
- Where
- 12 sites in United States
- Volunteers
- 103 people
- Sponsor
- Topcon Medical Systems, Inc.
Mydriasis
Evaluation of Pupil Dilation Speed With the MAP Dispenser
1 mist or 2 mists of the study drug will be administered to both eyes according to a pre-specified randomization plan to determine the effect on pupil dilation
- Trial name
- SPEED (NCT04907474)
- Testing
- tropicamide-phenylephrine fixed combination ophthalmic solution
- Where
- Mexico
- Volunteers
- 61 people, healthy volunteers welcome
- Sponsor
- Eyenovia Inc.
Keratoconus and Ectasia
Safety and Effectiveness Study of the VEGA UV-A System for Cross-linking in Eyes With Keratoconus and Ectasia
The purpose of this research study is to evaluate the long tern safety and effectiveness of cross-linking in eyes with keratoconus and ectasia.
- Trial name
- NCT01398852
- Testing
- Riboflavin, VEGA UV-A Illumination System
- Where
- 13 sites in United States
- Volunteers
- 500 people
- Sponsor
- Topcon Medical Systems, Inc.
Chronic Sinusitis
In-office Placement of the Propel Mini Sinus Implant in the Frontal Sinus Ostia
A randomized controlled trial
- Trial name
- FRONTIER (NCT02880514)
- Testing
- PROPEL Mini Sinus Implant, Balloon Sinus Dilation Alone
- Where
- 9 sites in United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Intersect ENT
Chronic Rhinosinusitis (Diagnosis)
A Clinical Evaluation of PROPEL® Contour Sinus Implant
The objective of this study is to evaluate the efficacy of PROPEL Contour placement following an in-office frontal sinus balloon dilation (SBD) in patients with chronic rhinosinusitis (CRS)
- Trial name
- EXPAND (NCT04858802)
- Testing
- PROPEL Contour Sinus Implant, Balloon Sinus Dilation Alone
- Where
- 14 sites in United States
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- Intersect ENT
Mydriasis, Dilation
Safety and Efficacy of Ophthalmic Phentolamine Mesylate to Reverse Pharmacologically Induced Mydriasis
The objectives of this study are: To evaluate the efficacy of Nyxol (phentolamine mesylate ophthalmic solution 1%) to expedite the reversal of pharmacologic mydriasis To evaluate the safety of Nyxol To evaluate the effect of…
- Trial name
- NCT04024891
- Testing
- Phentolamine Mesylate Ophthalmic Solution 1%
- Where
- 4 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Opus Genetics, Inc