Clinical trials: Medical Device
Thromboembolic Events
Clinical Performance Evaluation of Pefakit® PiCT® UC In Vitro Diagnostic Medical Device
To demonstrate the substantial equivalence (SE) of Pefakit® PiCT® UC (test device, T) to aPTT-SP (Hemosil) (predicate device, P) in determining heparin levels in subjects undergoing heparin therapy in support of a United States…
- Trial name
- NCT02052544
- Where
- 3 sites in United States, Germany and 1 more
- Volunteers
- 123 people
- Sponsor
- dsm-firmenich Switzerland AG
Benign Brain Tumor, Malignant Brain Tumor
Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis
Intra-operative evaluation of residual brain tumor currently relies on frozen-section histopathology, which typically requires 20-30 minutes for tissue processing and interpretation, prolonging operative time and increasing…
- Trial name
- cCeLLExvivo (NCT06098248)
- Testing
- cCeLL - Ex vivo
- Where
- 4 sites in Canada, South Korea
- Volunteers
- 285 people
- Sponsor
- VPIX Medical
Congestive Heart Failure
Interventricular Delay of Lumax HF-T for Heart Failure
The purpose of this study is to demonstrate that the safety and efficacy of the Lumax HF-T with optimized interventricular delay biventricular pacing (OPT) is non-inferior to the Lumax HF-T with simultaneous biventricular pacing…
- Trial name
- NCT00508391
- Testing
- Optimized interventricular delay biventricular pacing
- Where
- 19 sites in United States, Switzerland
- Volunteers
- 122 people
- Sponsor
- Biotronik, Inc.
Heart Failure, LVAD
The Left Ventricular Assist Device (LVAD) Off or On Pump Implantation Study
The purpose of this study is to compare adverse events after off-pump LVAD surgery or on-pump LVAD surgery.
- Trial name
- LVAD-ON-OFF (NCT04219618)
- Testing
- Off-Pump, On-Pump
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- The University of Texas Health Science Center, Houston
Adenocarcinoma of the Prostate
The Prostate Immobilization Device Study
The purpose of this study is to compare reproducibility of the device position and location of the prostate rectum interface between two immobilization devices for radiation therapy of prostate carcinoma.
- Trial name
- NCT01408706
- Testing
- Miller Air tip, Radiadyne Immobilizer
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- James Taylor
Laparoscopic Surgery
Device to Assist With Abdominal Access During Laparoscopic Surgery
The purpose of this study is to assess the safety and ease of use of a TauTona Pneumoperitoneum Assist Device (TPAD) to assist with obtaining peritoneal access with a Veress needle, and for placing a primary trocar, during…
- Trial name
- NCT04392635
- Testing
- TauTona Pneumoperitoneum Assist Device (TPAD), Standard of Care (SOC)
- Where
- United States
- Volunteers
- 31 people, healthy volunteers welcome
- Sponsor
- Stanford University
Head and Neck Cancer
Study of Personalized Sterile Humidification Device for Mucositis in Head and Neck Cancer Patients
This is a single arm study of the use of a personalized sterile humidification device for 12 weeks for head and neck cancer patients undergoing radiation therapy to determine if the usage of this humidification system will result…
- Trial name
- NCT01930435
- Testing
- Sterile Humidification Device
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of California, San Francisco
Diagnostic and/or Interventional Radiology Procedures
Angio-Seal Interventional Radiology (IR) Registry
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient…
- Trial name
- NCT01222104
- Where
- 10 sites in United States
- Volunteers
- 634 people
- Sponsor
- Abbott Medical Devices
Stress Urinary Incontinence
A Pilot Clinical Study of the Efficacy and Safety of a Disposable Intravaginal Device for Stress Urinary Incontinence
This pilot study will evaluate the efficacy of the pessary (disposable intra-vaginal device) by reduction in urine leakage in women with stress urinary incontinence (SUI).
- Trial name
- NCT01762345
- Testing
- pessary (disposable intra-vaginal device)
- Where
- United States
- Volunteers
- 148 people
- Sponsor
- Procter and Gamble
Degenerative Disc Disease
Retrospective/Prospective Data Collection on the LDR ROIC Interbody Fusion Device With VerteBRIDGE Plating
The purpose of this combined retrospective and prospective clinical study is to examine the clinical outcomes of the ROI-C® anterior cervical interbody fusion device with VerteBRIDGE® plating to treat single level degenerative…
- Trial name
- NCT02104167
- Testing
- ROIC interbody cage with VerteBRIDGE plating
- Where
- 7 sites in United States
- Volunteers
- 110 people
- Sponsor
- LDR Spine USA
Androgenetic Alopecia, Hair Loss
Treatment of Androgenic Alopecia in Males
The purpose of this study is to evaluate the change in terminal hair count at 16 and 26 weeks compared to baseline measurements.
- Conditions
- Androgenetic Alopecia, Hair Loss, Male Pattern Baldness
- Trial name
- NCT00947219
- Testing
- HairMax LaserComb, Control device
- Where
- 3 sites in United States
- Volunteers
- 79 people, healthy volunteers welcome
- Sponsor
- Lexington International, LLC
Healthy
Comparison Bioequivalence Study: Pre-filled Syringe (Reference) Versus Auto-injection Device (Test)
To compare the bioavailability of a single 400 mg dose of certolizumab pegol solution (2 x 200mg subcutaneous injections) injected either by a pre-filled syringe (reference) or by an auto-injection device (test).
- Trial name
- NCT00845663
- Testing
- Certolizumab pegol
- Where
- France
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- UCB Pharma
Facial Injuries, Tissue Injury
Effect of Concentrating Endogenous Stromal Cells in the Fat Graft Using TGI Device
The overall purpose of this research is to evaluate the physical changes that occur over time after fat grafting for craniofacial trauma.
- Trial name
- AFIRM-TGI (NCT01924364)
- Testing
- Tissue Genesis Cell Isolation System™ (TGI CIS), Standard of care fat grafting
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- J. Peter Rubin, MD
Total Knee Replacement Surgery
Adductor Canal Catheter Effectiveness and Safety Study
PRIMARY OBJECTIVE: Compare the effect of usual care with an adductor canal catheter (ACC) containing ropivacaine to the effect of usual care without an ACC on the second-postoperative-day pain levels among patients undergoing…
- Trial name
- ACCESS (NCT04639128)
- Testing
- Adductor Canal Catheter
- Where
- United States
- Volunteers
- 126 people
- Sponsor
- Kaiser Permanente
Xerostomia
Effects of an External Oral Irrigation Device on Patients With Dry Mouth
The purpose of this research study is to test the effectiveness of treating dry mouth through water rehydration using this extra oral water pump/irrigation device.
- Trial name
- NCT04901507
- Testing
- The Voutia System
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Virginia Commonwealth University
Monitoring, Intraoperative
Effects of IV Administration of Ketamine on the Analgesia Nociception Index (ANI) Measured With the PhysioDoloris
This study evaluates effects of the analgesic ketamine on ANI measurements (Anti Nociceptive Index)
- Trial name
- NCT01717521
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- University of Washington
Image, Body
Diagnostic Accuracy of Handheld vs Traditional Ultrasound
Patients receiving a point-of-care ultrasound will be randomized into a portable, handheld device or a traditional cart-based ultrasound machine to compare diagnostic capability.
- Trial name
- NCT05196776
- Testing
- Portable, handheld point-of-care ultrasound device, Cart-based point-of-care ultrasound device
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Temple University
Medical Devices
BIO|CONCEPT.Renamic Neo Study
The BIO|CONCEPT.Renamic.Neo study is designed as a pre-market study to provide clinical data and supporting evidence of the safety, performance and usability of the Renamic Neo programmer system.
- Trial name
- NCT04350008
- Testing
- Renamic Neo programmer device, including software; PK-222-L ECG cable
- Where
- 8 sites in Australia
- Volunteers
- 110 people
- Sponsor
- Biotronik Australia Pty Ltd.
Asthma
Investigation of the 24 Hour Forced Expiratory Flow in 1 Second (FEV1) Profile of a Single Dose of Indacaterol/Mometasone Delivered Via the TWISTHALER® Device in Adult Patients With Persistent Asthma
This study is designed to provide data about the 24 hours FEV1 profile, safety and tolerability of indacaterol/mometasone TWISTHALER device compared to placebo and using fluticasone/salmeterol as an active control.
- Trial name
- NCT00557440
- Testing
- fluticasone propionate/salmeterol, indacaterol maleate / mometasone furoate
- Where
- 6 sites in Belgium, Germany
- Volunteers
- 37 people
- Sponsor
- Novartis
Balance
Villency-Proof of Action: Foot Device, Balance and Sway, Kinematics of Walking
This study involves the use of a newly designed shoe insole device (also referred to as a foot insole device) similar to various shoe insoles or inserts you can buy at a store or pharmacy.
- Trial name
- NCT03663816
- Testing
- experimental foot device
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- University of Florida
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