Clinical trials: Safety and Performance
Stoma Ileostomy
Performance and Safety Evaluation of the SenSura® Mio Baby Device in Subjects With a Stoma
The aim of the non-interventional Post Market Clinical Follow-up (PMCF) study is to follow performance and safety of the newly marketed SenSura® Mio Baby device in a real-life setting.
- Trial name
- NCT03929978
- Volunteers
- healthy volunteers welcome
- Sponsor
- Coloplast A/S
Tattoo; Pigmentation
Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
An Open-Label, Single-Center, Prospective, Observational, Clinical Use Study Evaluating the Safety and Performance Characteristics of Ephemeral® Tattoo Ink in Healthy Subjects
- Trial name
- NCT05877833
- Testing
- Vibrancy Assessment
- Where
- United States
- Volunteers
- 45 people, healthy volunteers welcome
- Sponsor
- Ephemeral Solutions Inc.
Cataract, Lens Opacities
Clinical Study to Evaluate Clinical Outcomes of LuxSmart IOL as Compared With LuxGood IOL
This study is a multicentric, prospective, randomised, controlled, post-market clinical follow up (PMCF) study to investigate safety, visual outcomes and contrast sensitivity after bilateral implantation of either LuxSmart IOLs…
- Trial name
- NCT06105190
- Testing
- Implantation of premium monofocal IOL, LuxSmart (device under investigation), Implantation of monofocal IOL, LuxGood (control device)
- Where
- 8 sites in Austria, Czechia and 4 more
- Volunteers
- 251 people, healthy volunteers welcome
- Sponsor
- Cutting Edge SAS
TMJ Disc Disorder, TMJ Pain
MDR-JuggerKnot Mini Soft Anchor in Maxillofacial TMJ
The objective of this retrospective consecutive series PMCF study is to collect data confirming safety, performance and clinical benefits of the JuggerKnot Mini Soft Anchor (implant and instrumentation) when used for soft tissue…
- Conditions
- TMJ Disc Disorder, TMJ Pain, TMJ Sounds on Opening/Closing the Jaw, TMJ Disease
- Trial name
- NCT04033692
- Testing
- JuggerKnot Mini Soft Anchor
- Volunteers
- healthy volunteers welcome
- Sponsor
- Zimmer Biomet
Vital Signs
A Single Center Study to Demonstrate the Safety and Performance of Lifelight® First Software Application
This study validates Lifelight® First, a software application, in a laboratory setting. Participants will undergo testing to obtain measurements from one or more of the four vital signs.
- Trial name
- NCT03998098
- Testing
- Oxygen Saturation (Oximetry), Heart Rate (Pulse), Respiratory Rate
- Where
- United Kingdom
- Volunteers
- 85 people, healthy volunteers welcome
- Sponsor
- Xim Limited
Aesthetic Correction of the Lips
Clinical Investigation on Lips Treated With HA-filler
A post-market-clinical follow-up investigation to confirm the clinical safety and performance profile of Decoria® Essence for the correction and improvement of lips profile.
- Trial name
- DAG-ESS (NCT07188818)
- Testing
- Decoria Essence
- Where
- 6 sites in Sweden
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- Bohus Biotech AB
Education, Obstetrics
'In Situ Simulation' Versus 'Off Site Simulation' in Obstetric Emergencies
Care for pregnant is a field where unexpected emergencies occur, however emergencies are rare and hence competences difficult to learn. Therefore, it can be relevant to use simulation-based medical education.
- Conditions
- Education, Obstetrics, Simulation, 'In Situ Simulation'
- Trial name
- NCT01792674
- Testing
- In situ simulation, Off site simulation
- Where
- Denmark
- Volunteers
- 97 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Sleep, Fatigue
Sleep, Mindfulness, and Shift-Level Safety Performance in Perianesthesia Nurses
Perianesthesia (preoperative and postanesthesia care unit, PACU) nurses work rotating, often extended shifts that can disrupt sleep and increase fatigue, both of which are recognized threats to patient safety in high-acuity…
- Conditions
- Sleep, Fatigue, Patient Safety
- Trial name
- NCT07832721
- Testing
- Sleep, Mindfulness, and Shift-Level Safety Observation Toolkit
- Where
- Turkey (Türkiye)
- Volunteers
- 300 people, healthy volunteers welcome
- Sponsor
- Volkan Gokmen
Rhytides, Wrinkle
Clinical Evaluation of Fractional Radiofrequency for the Treatment and Reduction of Facial Wrinkles
Prospective, single centre, evaluator-blind study of the safety and performance of fractional radiofrequency (RF) for the treatment and reduction of facial wrinkles.
- Trial name
- NCT03831477
- Testing
- Venus Viva
- Where
- United States
- Volunteers
- 15 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Non Ruptured Tendon Injuries, Tendinopathy
Tissue Repair Device (VergenixTM STR) in Patients With Epicondylitis (Tennis Elbow)
The VergenixTM STR device is intended for the repair of non ruptured tendon injuries (Tendinopathy).
- Trial name
- CP-STR-01 (NCT02309307)
- Testing
- Tissue Repair Device (VergenixTM STR)
- Where
- 3 sites in Israel
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Collplant
Prostate Cancer, Prostate Neoplasm
Robotic-arm Assisted 68 Ga PSMA PET/CT Guided Prostate Biopsy Versus MR Directed Cognitive Fusion TRUS Guided Prostate Biopsy (PROBIOP)
The present study aimed to compare the diagnostic accuracy, radiation exposure, complication rates between 68Ga-PSMA PET/CT guided robotic arm assisted prostate biopsy and MRI directed TRUS guided prostate biopsy in PIRADS 4/5…
- Trial name
- PROBIOP (NCT05137561)
- Testing
- PSMA PET guided prostate biopsy, MRI directed TRUS guided prostate biopsy
- Where
- India
- Volunteers
- 217 people, healthy volunteers welcome
- Sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
Healthy Volunteers, Medical Device
A Study Investigating the Safety and Performance of DV3395, a New Concept Device for the Delivery of Medicine.
This study investigates how safe the study device DV3395-C1 is when swallowed by healthy men and women. By the use of X-ray the device will be followed from the mouth, through the food pipe to the stomach and then into the gut.
- Trial name
- NCT05314283
- Testing
- DV3395 C1
- Where
- Netherlands
- Volunteers
- 65 people, healthy volunteers welcome
- Sponsor
- Novo Nordisk A/S
Healthy
Clinical Performance of All-in-One Light Multi-purpose for Silicone Hydrogel Contact Lenses
A clinical trial was conducted to assess the safety and acceptability of the Sauflon Multipurpose Solution when used with four different silicone hydrogel contact lens brands and one conventional hydrogel control lens was…
- Trial name
- NCT01392937
- Testing
- All-in-One Light multipurpose, Aquify care
- Where
- United Kingdom
- Volunteers
- 257 people, healthy volunteers welcome
- Sponsor
- Sauflon Pharmaceuticals Ltd
Damage Muscle, Body Weight Changes
Chronic Study on Body Composition, Training, Performance, and Recovery
The chronic phase of the study will evaluate the effects of pre-exercise and post-exercise ingestion of a multi-ingredient supplement on adaptations to a 6-week exercise program consisting of both resistance training and high…
- Conditions
- Damage Muscle, Body Weight Changes, Performance Enhancing Product Use
- Trial name
- NCT04230824
- Testing
- Pre-workout plus and Protein recovery plus, 6-week resistance training program
- Where
- United States
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Pharmanex
Postpartum Hemorrhage
Celox™ PPH for Reaching Haemostasis in Patients With Postpartum Hemorrhage
This is a post market prospective, single arm clinical investigation to continuously assess the safety performance and effectiveness of the Celox™ PPH as a uterine haemostatic tamponade treatment for uterine postpartum hemorrhage…
- Trial name
- NCT06033170
- Testing
- CELOX™ PPH
- Volunteers
- 96 people, healthy volunteers welcome
- Sponsor
- Medtrade
Lipolysis
RF and PEMF Following Liposuction
The Venus Legacy LB2 Body applicator is intended for circumference reduction treatment by reducing fat cell size and enhancing collagen synthesis as the result of thermal and non-thermal collagen stimulation.
- Trial name
- NCT03588702
- Testing
- RF and PEMF treatment
- Where
- Spain
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Venus Concept
Behavior
RxConnect User Testing Study
Background Medication errors are the leading cause of preventable harm in healthcare settings worldwide. An estimated 237 million medication errors occur in England alone every year, with 66 million considered clinically…
- Trial name
- NCT05493072
- Testing
- RxConnect
- Where
- United Kingdom
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Imperial College London
Medical Device, Medical Device Performance
Clinical Evaluation of an Airborne Pathogen Containment Device: Randomized Open-label Equivalence Trial During Endotracheal Intubation
The aim of this study is to test a bubble-like dome (made of clear plastic) being placed over patients' heads during surgery as a tool to prevent the spread of germs through the air in hospitals.
- Conditions
- Medical Device, Medical Device Performance, Aerosol Generating Procedure
- Trial name
- NCT06968377
- Testing
- A novel airborne pathogen containment device.
- Where
- Canada
- Volunteers
- 80 people, healthy volunteers welcome
- Sponsor
- IWK Health Centre
Wrinkles and Rhytides
Treatment of Aging Signs of the Skin With Bipolar Radiofrequency
This is a retrospective data collection from patients treated with the bipolar radiofrequency applicator (Coaxipolar) of the Accent devices.
- Trial name
- NCT07739212
- Where
- Kosovo
- Volunteers
- 150 people, healthy volunteers welcome
- Sponsor
- Alma Mater Europaea College of Medical Sciences "Rezonanca"
Retention, Urinary
Investigation of New Intermittent Catheters in Healthy Volunteers
Investigation of non-CE marked intermittent catheters. The study was a randomized, single blinded, cross-over investigation comparing two new catheters with a comparator catheter in 30 adult healthy volunteers.
- Trial name
- NCT04445051
- Testing
- SpeediCath® Standard male or female, New intermittent Variant 1 catheter for male or female, New intermittent Variant 2 catheter for male or female
- Where
- Denmark
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- Coloplast A/S