Clinical trials: Safety and Performance
Urinary Retention, Neurogenic Bladder
Connected Catheter- Safety and Effectiveness Study
The Connected Catheter is a fully internal, urethral indwelling urinary prosthesis designed for improved bladder management in males with urinary retention disorders requiring catheterization.
- Conditions
- Urinary Retention, Neurogenic Bladder, Urologic Diseases
- Trial name
- NCT03843073
- Testing
- Connected Urinary Catheter
- Where
- 9 sites in United States
- Volunteers
- 9 people
- Sponsor
- Spinal Singularity
HSV-2 Infection, Genital Herpes
The VIBLOK SAfety and perFormancE Trial
Genital herpes has a high prevalence in industrialized as well as developing countries. Genital herpes causes genital ulcers, increases risk for acquiring HIV infection, and may be transmitted mother to child during birth with…
- Trial name
- SAFE (NCT03080961)
- Testing
- VIBLOK barrier cream
- Where
- 3 sites in Netherlands
- Volunteers
- 82 people
- Sponsor
- CLJI Worldwide
Colon Cancer, Rectum Cancer
Phase I of SGM-101 in Patients With Cancer of the Colon, Rectum or Pancreas
This study evaluates the safety and performance of SGM-101, a Carcinoembryonic Antigen (CEA)-specific chimeric antibody conjugated with a NIR emitting fluorochrome, for the visualization of CEA-expressing cancers during surgery.
- Conditions
- Colon Cancer, Rectum Cancer, Pancreas Cancer, Metastatic Colorectal Cancer
- Trial name
- NCT02973672
- Testing
- SGM-101
- Where
- 3 sites in Netherlands
- Volunteers
- 75 people
- Sponsor
- Surgimab
Non-valvular Atrial Fibrillation
The Conformal Prague Study
A prospective, single center, open-label, single arm, study to evaluate the safety and technical performance of the CLAAS system for closure of the left atrial appendage.
- Trial name
- NCT04193826
- Testing
- Left Atrial Appendage Closure
- Where
- Czechia
- Volunteers
- 20 people
- Sponsor
- Conformal Medical, Inc
Eosinophilic Esophagitis
A Study to Investigate Safety and Tolerability of NDX-3315 and NDX-3324 in Healthy Participants and Patients With Eosinophilic Esophagitis
An open-label phase 2 study to assess the safety and exploratory diagnostic performance of the oral radiopharmaceutical agent NDX-3315 and NDX-3324 in healthy participants and patients with eosinophilic esophagitis (EoE).
- Trial name
- NCT05757856
- Testing
- NDX-3315, NDX-3324, SPECT/CT Imaging
- Where
- 3 sites in United States
- Volunteers
- 34 people, healthy volunteers welcome
- Sponsor
- NexEos Diagnostics, Inc.
Safety of the CytaCoat Foley Catheter, Performance of the CytaCoat Foley Catheter
Assessing Safety and Performance of the Novel CytaCoat Foley Catheter
This study is a prospective, single-center, single-blind, randomized, parallel assignment, controlled study to evaluate the safety and performance of the novel CytaCoat Foley catheter when compared to a Sterimed uncoated Foley…
- Trial name
- CYTA-FOL-2 (NCT07070921)
- Testing
- Foley catheter
- Where
- India
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- CytaCoat AB
NEC
Sensing Oxygen Saturations Using Abdominal NIRS With an Investigational Realtime Device (Songbird)
Preterm infants are highly vulnerable and may suffer from multiple life-threatening conditions that manifest low tissue oxygenation (StO2).
- Trial name
- (Songbird) (NCT05278247)
- Testing
- NIRS
- Volunteers
- 50 people
- Sponsor
- Carag AG
Muscle Wasting, Obesity & Overweight
Testing the Efficacy, Safety, and PK of 20E in Patients With Obesity Who Are Starting Treatment With the GLP-1 Agonist Semaglutide for Weight Loss.
The goal of this clinical trial is to learn if BIO101 treatment can improve the muscle strength of participants males and females, aged 18 to 84 years old, suffering from obesity (BMI≥30) or overweight (BMI ≥ 27) with one or more…
- Conditions
- Muscle Wasting, Obesity & Overweight, Obesity
- Trial name
- OBA (NCT07411378)
- Testing
- BIO101, Semaglutide
- Volunteers
- 164 people
- Sponsor
- Biophytis
Calcified Coronary Lesions
Effectiveness and Safety of a Novel Intravascular Lithotripsy System in Severely Calcified Coronary Lesions(COCALP)
This study is a prospective, multicenter, single-arm trial designed to investigate the effectiveness and safety of this intravascular lithotripsy system to treat severely calcified coronary lesions before stenting.
- Trial name
- COCALP (NCT06787547)
- Testing
- IVL(Sonico-CX)
- Where
- 11 sites in China
- Volunteers
- 266 people
- Sponsor
- Spectrumedics Medical Technology(Shanghai)Co.,Ltd
Ankle Fractures, Knee Fractures
Performance and Safety Follow-up of Bioabsorbable Headless Inion CompressOnTM Screws in the Fixation of Bone Fractures in Ankle, Knee and Elbow of Pediatric and Adolescent Patients
The study in question is a post market clinical follow up (PMCF) study to follow up the safety and performance of bioabsorbable headless compression screw Inion CompressOn in fracture fixation of the ankle, knee and elbow of…
- Conditions
- Ankle Fractures, Knee Fractures, Elbow Fractures
- Trial name
- NCT07473947
- Testing
- Fracture fixation operation
- Where
- Finland
- Volunteers
- 80 people
- Sponsor
- Inion Oy
Thoracic Aortic Diseases
The Single Branch NEXUS™ Clinical Study
A prospective, open-label, non-randomized, interventional clinical study, sponsored by Endospan Ltd. Subjects will be followed-up for five years.
- Trial name
- NexusSB (NCT03208504)
- Testing
- Nexus™ Aortic Arch Stent graft
- Where
- Germany
- Volunteers
- 1 people
- Sponsor
- Endospan Ltd.
Chronic Low-back Pain, Herniated Disc
LISA Post Market Clinical Follow-Up Study: Documentation of Clinical Outcomes After Surgery With LISA Implant
The study is a post-market surveillance study of the Lumbar Implant for Stiffness Augmentation (LISA), a medical device, which is used to treat low-back pain that accompanies degenerative lesions of grades II, III, and IV…
- Conditions
- Chronic Low-back Pain, Herniated Disc, Degenerative Disc Disease, Lumbar Canal Stenosis
- Trial name
- LISA-PMCF (NCT04631133)
- Testing
- Lumbar Implant for Stiffness Augmentation (LISA)
- Where
- 5 sites in Denmark, France and 1 more
- Volunteers
- 136 people
- Sponsor
- BACKBONE
Tinnitus
The Treatment of Tinnitus With Transcutaneous Non-invasive Vagus Nerve Stimulation
The t-VNS STv3 device is a non-invasive, transcutaneous neurostimulator for influencing the afferent branches of the nervus vagus around the human ear.
- Trial name
- NCT01176734
- Testing
- tVNS-Device
- Where
- Germany
- Volunteers
- 50 people
- Sponsor
- cerbomed GmbH
Aortic Valve Replacement
Safety and Performance Study of the CardioGard Cannula
The objective of the study is to collect additional information related to the safety and performance of the CardioGard Cannula during bypass procedures.
- Trial name
- NCT01554709
- Testing
- Aortic Cannulas (CardioGard)
- Where
- 5 sites in Germany, Israel and 1 more
- Volunteers
- 71 people
- Sponsor
- CardioGard Medical Ltd.
Retention, Urinary
Investigation of Non-CE Marked Intermittent Catheters.
Investigation of novel non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters for males with a comparator catheter
- Trial name
- NCT04543136
- Testing
- SpeediCath® Standard male, New intermittent Variant 1 catheter for males, New intermittent Variant 2 catheter for males
- Where
- Denmark
- Volunteers
- 16 people
- Sponsor
- Coloplast A/S
Mitral Valve Insufficiency, Mitral Valve Prolapse
European FIH Study - NeoChord Transcatheter Mitral Repair System for Symptomatic Mitral Regurgitation
Safety and performance evaluation of the NeoChord Transcatheter Mitral Repair System in patients with degenerative mitral valve regurgitation.
- Conditions
- Mitral Valve Insufficiency, Mitral Valve Prolapse, Degenerative, Mitral Regurgitation
- Trial name
- NCT05425628
- Testing
- NeoChord Transcatheter Mitral Repair System (or "NeoChord System")
- Volunteers
- 30 people
- Sponsor
- NeoChord
Stroke
Efficacy, Safety, Tolerability and Pharmacokinetics of SUN13837 to Treat Acute Stroke
The purpose of this study is to evaluate the safety and tolerability of SUN13837 and to determine whether SUN13837 improves the physical performance, relative to placebo, following an acute stroke in adult subjects.
- Trial name
- NCT02258880
- Testing
- SUN13837
- Where
- 53 sites in United States, Canada and 2 more
- Sponsor
- Daiichi Sankyo
Foot Diseases
Study to Evaluate Safety, of NextraTM in Surgery to Fuse the Proximal-interphalangeal- Joints
Hammertoe deformity is the most common deformity of the lesser toes. It primarily comprises flexion deformity of the proximal interphalangeal (PIP) joint of the toe, with hyperextension of the metatarsophalangeal (MTP).
- Trial name
- NCT01604070
- Where
- 4 sites in United States
- Volunteers
- 98 people, healthy volunteers welcome
- Sponsor
- eMedtrain Inc.
Cochlear Hearing Loss
Safety and Performance of Ultra/Ultra 3D Cl With HiFocus SlimJ Electrode in Adults With Severe-to-profound Hearing Loss
This is a prospective study designed to evaluate the safety and performance of the HiResTM Ultra Cl HiFocusTM SlimJ Electrode and HiResTM Ultra 3D Cl HiFocusTM SlimJ Electrode (Ultra X) under normal conditions of use as it is…
- Trial name
- NCT04929470
- Testing
- cochlear implantation
- Where
- 3 sites in Germany
- Volunteers
- 37 people
- Sponsor
- Advanced Bionics AG
Digital Nerve Injury
TISSIUM's Nerve Coaptation Device First-in-Human Clinical Trial
The purpose of this study is to collect initial safety and device performance data of the TISSIUM's nerve coaptation device for the sutureless repair of digital nerve injuries of the hand in which there has been no substantial…
- Trial name
- NCT04327154
- Testing
- TISSIUM™ Nerve Coaptation Device
- Where
- 2 sites in Australia
- Volunteers
- 12 people
- Sponsor
- Tissium
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