Clinical trials: Safety and Performance
Arteriovenous Malformation, Hemangioma
Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB
This is an open-label whole-body PET/CT study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in healthy volunteers and patients with suspected…
- Conditions
- Arteriovenous Malformation, Hemangioma, Neoplasms Lymph Nodes, Lymphedema
- Trial name
- NCT02496013
- Testing
- 68Ga-NEB
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Peking Union Medical College Hospital
Healthy Volunteers
Performance and Safety of Restylane Lidocaine for Treatment of Depressed Facial Acne Scars
The purpose of this study is to evaluate performance and safety of Restylane Lidocaine for treatment of depressed facial acne scars
- Trial name
- NCT03127384
- Testing
- Restylane Lidocaine, No-treatment control
- Where
- 2 sites in Germany
- Volunteers
- 49 people, healthy volunteers welcome
- Sponsor
- Galderma R&D
Diabetes Mellitus, Type 2
Safety and Performance of the Glyconics-SX System (ANODE02)
The main clinical study objective is to retrieve initial high quality spectra measurements indicative of the accuracy of the Glyconics-SX System in distinguishing between individuals with or without T2DM based on known and/or…
- Trial name
- ANODE02 (NCT05476016)
- Testing
- Near-infrared (NIR)
- Where
- Spain
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Glyconics Ltd
Bloodstream Infection
Reduction of Pathogen Load From the Blood in Septic Patients With Suspected, Life-threatening Bloodstream Infection
Safety and Performance Evaluation of Seraph 100 Microbind Affinity Blood Filter (Seraph 100) in the reduction of pathogen load from the blood in septic patients with suspected, life-threatening bloodstream infection
- Trial name
- NCT04260789
- Testing
- Seraph 100,The Microbind Affinity Blood Filter
- Where
- 25 sites in Austria, Belgium and 7 more
- Volunteers
- 232 people, healthy volunteers welcome
- Sponsor
- ExThera Medical Europe BV
Diabetes Mellitus, Healthy
Reconfirming the Safety and Performance of the Glyconics-DS System in Known Populations With and Without Diabetes
A single-site, open label, confirmatory study assessing two biomarkers indicative of levels of glycaemia; glycated keratin in fingernails and glycated haemoglobin (HbA1c). Screening for diabetes
- Trial name
- ANODE04 (NCT07039357)
- Testing
- Near-infrared (spectroscopy) for non-invasive assessment of glycated keratin of nail
- Where
- 2 sites in United Kingdom
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Glyconics Ltd
High Altitude, Hypobaric Hypoxia
The Effect of Acute High Altitude Exposure on Rescuer Performance and Patient Care
Rescue services in mountainous regions are frequently called to missions at altitudes >3000 m. Under the difficult conditions of acute exposure to altitude, the crews then have to undertake demanding medical and rescue measures.
- Conditions
- High Altitude, Hypobaric Hypoxia, Risk Reduction
- Trial name
- NCT06446427
- Testing
- Acute high altitude exposure, Acute high altitude exposure, with supplementary oxygen, Subacute high altitude exposure, after having spent a night at high altitude
- Where
- 2 sites in Switzerland
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- Insel Gruppe AG, University Hospital Bern
Cognition, Stress Reaction
rTMS to Enhance Cognitive Performance and Promote Resilience
The purpose of this study is to determine the most effective dose of brief, non-invasive brain stimulation (repetitive transcranial magnetic stimulation, rTMS) for improving cognitive functions such as attention and memory as…
- Trial name
- NCT04123496
- Testing
- rTMS
- Where
- United States
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Medical University of South Carolina
Contraceptive Usage
A Prospective Observational Study of the Performance of Zarin in Kenya
This will be a non-comparative prospective observational study of women using Zarin as a primary method of contraception in Kenya.
- Trial name
- NCT01334190
- Where
- Kenya
- Volunteers
- 602 people, healthy volunteers welcome
- Sponsor
- FHI 360
Ventricular Arrythmia, Lead
Safety and Performance of INVICTA Ventricular DF4 LEADS With Active Fixation-(APOLLO)
The primary objective of this study is to assess the safety and key electrical performance of the INVICTA leads equipped with DF4 connector: ACTIVE fixation type models (single and dual coil: INVICTA 1CR, INVICTA 2CR)
- Conditions
- Ventricular Arrythmia, Lead, ICD, Heart Failure
- Trial name
- APOLLO (NCT04590144)
- Testing
- INVICTA lead
- Where
- 45 sites in Austria, France and 6 more
- Volunteers
- 446 people, healthy volunteers welcome
- Sponsor
- MicroPort CRM
Atrium; Fibrillation
Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation
A Prospective, Open, Multi-Center, Controlled Study to Evaluate the Safety, Performance and Efficacy of the CardiacSense1 for Detection of Atrial Fibrillation.
- Trial name
- NCT03477734
- Testing
- CS1 & heart monitor
- Where
- 2 sites in Israel
- Volunteers
- 53 people, healthy volunteers welcome
- Sponsor
- CardiacSense Ltd.
In-stent Restenosis, Stent Fracture
Pilot Study of the α Prototype NIMBLE System: Feasibility, Safety, and Initial Performance in Non-Invasive Detection of Coronary In-Stent Restenosis
The NIMBLE-I study is a prospective, unicentric, single arm, feasibility clinical trial designed to evaluate a novel medical device for the non-invasive monitoring of coronary stents.
- Conditions
- In-stent Restenosis, Stent Fracture, Stent Complication
- Trial name
- NIMBLE-I (NCT06968858)
- Testing
- NIMBLE test
- Where
- Spain
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Nimble Diagnostics S.L.
Diagnostic Imaging
PET/CT Imaging for Radiation Dosimetry, Plasma Pharmacokinetics, Safety and Tolerability in Healthy Volunteers and Safety, Tolerability and Diagnostic Performance of BAY86-9596 in Patients With Non-small Cell Lung Cancer, Breast Cancer, Head and Neck Cancer and Patients With Inflammations
Visual assessment of diagnostic PET/CT (positron emission tomography/computed tomography) images obtained after a single intravenous injection of BAY86-9596 in patients with cancer and inflammation
- Trial name
- NCT01089998
- Testing
- BAY86-9596, Fludeoxyglucose (18F)-IBA
- Where
- 2 sites in Netherlands, Switzerland
- Volunteers
- 35 people, healthy volunteers welcome
- Sponsor
- Lantheus Biosciences Ltd.
Glaucoma, Ocular Hypertension
This Follow-up Extension Study is Aimed to Monitor the Long-term IOP-lowering Performance/Efficacy and Safety of the MINT® Procedure in Open Angle Glaucoma Eyes.
This follow-up extension study is planned to invite all patients who underwent the MINT® surgery and completed Month 24 Visit in the prior MMS EEU-7 study.
- Conditions
- Glaucoma, Ocular Hypertension, Open-Angle Glaucoma
- Trial name
- NCT07081347
- Testing
- MINT Minimally Invasive Nasal Trabeculostomy
- Where
- Armenia
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Sanoculis Ltd
Solid Tumor Malignancies
Clinical Evaluation of [68Ga]Ga-FFD PET Imaging in Healthy Volunteers and Patients With Solid Tumors
This is a prospective, single-center, open-label clinical study designed to evaluate the safety, biodistribution, radiation dosimetry, and diagnostic performance of [68Ga]Ga-FFD PET imaging.
- Trial name
- NCT07708103
- Testing
- [68Ga]Ga-FFD
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
To Assess the Safety, Effectiveness and User Experience of the Scu 300A IUB
Multivariate Assessment of the IUB Intrauterine Device Compared With a T380A IUD
The novel SCu300A IUB™ (hereafter IUB™) will be evaluated for safety and effectiveness in comparison with a market approved standard T shaped IUD containing 380sq.mm. of copper.
- Trial name
- NCT02036177
- Testing
- SCu300A IUB intrauterine device, T380A IUD
- Where
- 2 sites in Bulgaria, Romania
- Volunteers
- 366 people, healthy volunteers welcome
- Sponsor
- Ocon Medical Ltd.
Over Weight, Obesity
Safety and Performance Evaluation of Tulip Device in Healthy Overweight and Obese Volunteers
The study will assess the safety and performance of an intragastric auto-inflating and degradable balloon
- Trial name
- NCT01753609
- Testing
- Tulip capsule
- Where
- Israel
- Volunteers
- 8 people, healthy volunteers welcome
- Sponsor
- Tulip Medical Ltd.
Ankle Fractures, Bimalleolar Fractures
Fibulink Syndesmosis Repair System With Early Full-Weight Bearing
The purpose of the study is to evaluate the ability of the Fibulink Syndesmosis Repair System to maintain reduction of the ankle syndesmosis.
- Conditions
- Ankle Fractures, Bimalleolar Fractures, Syndesmotic Injuries, Bimalleolar Equivalent Fracture
- Trial name
- NCT06085586
- Testing
- Early Weight Bearing, Normal Weight Bearing
- Where
- United States
- Volunteers
- 56 people, healthy volunteers welcome
- Sponsor
- Maimonides Medical Center
Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers
Clinical Investigation on a Polynucleotide-based Device Used to Improve Skin Hydration
Adequate skin hydration is critical for maintaining healthy skin. Moreover, dehydration, together with reduction in cell renewal, loss of radiance, elasticity and firmness, is involved in skin aging.
- Conditions
- Aesthetic Improvement of the Skin, Skin Hydration in Healthy Volunteers, Skin Elasticity, Skin Turgor
- Trial name
- NCT07151859
- Testing
- PN30 (RDM16)
- Where
- Italy
- Volunteers
- 43 people, healthy volunteers welcome
- Sponsor
- Mastelli S.r.l
Altitude Edema
Advair HFA in Healthy and HAPE Predisposed Subjects
The current protocol is composed of two studies. The first study is designed to carefully evaluate the safety of high-dose salmeterol/fluticasone (Advair HFA) versus placebo (hydrofluoroalkane, HFA) administration over 7 days, as…
- Trial name
- SWIFTARC (NCT06040268)
- Testing
- Advair HFA
- Where
- United States
- Volunteers
- 60 people, healthy volunteers welcome
- Sponsor
- University of Colorado, Denver
Breast Cancer
HydroMARK Post-market Clinical Follow-up Study
The purpose of this study is to assess the safety and performance of the HydroMARK Breast Biopsy Site Marker manufactured in the Devicor Medical Products, Inc. Tijuana facility.
- Trial name
- NCT04622696
- Testing
- Ultrasound imaging
- Where
- 3 sites in United States
- Volunteers
- 730 people, healthy volunteers welcome
- Sponsor
- Devicor Medical Products, Inc.