Clinical trials: Safety and Performance
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
Lung Cancer
Clinical Investigation Evaluating the Performance, Safety and Clinical Benefit of the Endowave FlexAblate™ Microwave Ablation System in Patients Undergoing Lung Ablation Procedures.
The goal of this clinical trial is to learn if the FlexAblate™ Ablation System works to treat a lung cancer nodules and it will also learn about the safety of the ablation system.
- Trial name
- AURORA (NCT07291973)
- Testing
- Microwave Ablation
- Where
- 3 sites in France, United Kingdom
- Volunteers
- 43 people
- Sponsor
- Endowave Ltd.
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Advanced Heart Failure
First in Human Study of the Icoms Flowmaker
The Icoms® FlowMaker® is a cardiac assist system in the true sense of the word. As assisting means to help or rescue, its function is providing assistance to the heart, which will continue to have its own hemodynamic pump…
- Trial name
- FAIR (NCT07632586)
- Testing
- Cardiac assist device implantation during surgical intervention
- Where
- 2 sites in Czechia, France
- Volunteers
- 10 people
- Sponsor
- FineHeart
Coronary Artery Disease
First in Men Study: BIOMAG-I
A prospective, multi-center, first-in-man trial. Up to 115 subjects will be enrolled.
- Trial name
- NCT04157153
- Testing
- Implantation of a Sirolimus-Eluting Resorbable Coronary Magnesium Scaffold
- Where
- 14 sites in Austria, Belgium and 6 more
- Volunteers
- 116 people
- Sponsor
- Biotronik AG
Cataract, Presbyopia
Retrospective Clinical Investigation of the Safety and Performance of 640PM Trifocal IOL Implantation in Patients With Cataract and/or Ametropia (Hyperopia, Myopia) and/or Presbyopia
The clinical investigation objective is to evaluate safety and performance outcomes of trifocal IOL implantation to improve vision in patients with cataract and/or ametropia (hyperopia, myopia) and/or presbyopia.
- Conditions
- Cataract, Presbyopia, Hyperopia, Myopia
- Trial name
- NCT05735990
- Testing
- Intraocular lens
- Where
- Spain
- Volunteers
- 21 people
- Sponsor
- Medicontur Medical Engineering Ltd
Common Warts, Plantar Warts
Salicylic Acid Wart Patch for the Treatment of Common Warts and Plantar Warts
Common and plantar warts are a type of skin lesion caused by infection with the human papilloma virus. The incidence of warts is relatively high, with an estimated few to several per cent of the adult population affected.
- Trial name
- NCT06958237
- Testing
- salicylic acid wart patches
- Where
- Poland
- Volunteers
- 30 people
- Sponsor
- Langsteiner sp. z o.o.
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
Peripheral Arterial Disease
The Isthmus Logic Post Market Clinical Follow-up Study
Isthmus Logic Carbostent™ is a CE-marked cobalt chromium stent with a bio inducer surface for the treatment of peripheral iliac artery disease.
- Trial name
- NCT05616143
- Testing
- Isthmus Logic
- Where
- Italy
- Volunteers
- 37 people
- Sponsor
- CID S.p.A.
Coronary Artery Disease, Myocardial Ischemia
BIOFLOW-III All-comers Orsiro Safety and Performance Registry
This registry is a clinical post-market evaluation of the Orsiro LESS in subjects requiring coronary revascularization with Drug Eluting Stents (DES).
- Trial name
- BIOFLOW-III (NCT01553526)
- Where
- 43 sites in Austria, Chile and 11 more
- Volunteers
- 1,356 people
- Sponsor
- Biotronik AG
Pressure Ulcer, Diabetic Foot Ulcer
An Open, Non-comparative, Multicenter Investigation to Evaluate the Safety and Performance of Exufiber Ag+, a Gelling Fiber Silver Dressing, When Used in Medium to High Exuding Chronic Wounds
An open, non-comparative, multicenter investigation to evaluate the safety and performance of Exufiber Ag+, a gelling fiber silver dressing, when used in medium to high exuding chronic wounds
- Conditions
- Pressure Ulcer, Diabetic Foot Ulcer, Venous Leg Ulcer
- Trial name
- NCT05494450
- Testing
- ExufiberAG+
- Where
- 2 sites in United States
- Volunteers
- 46 people
- Sponsor
- Molnlycke Health Care AB
Gastrointestinal Anastomosis
Safety, Tolerability and Performance Profile of the Colospan Device CG-100 in Patients Undergoing Colorectal Surgery
The purpose of this study is to evaluate the CG-100 device, a single use, temporary intraluminal bypass device,intended to reduce contact of fecal content with an anastomotic site, following colorectal surgery (open or…
- Trial name
- NCT02109991
- Testing
- CG-100 device
- Where
- 8 sites in Belgium, Croatia and 2 more
- Volunteers
- 60 people
- Sponsor
- Colospan Ltd.
Diabetic Foot Ulcer, Venous Leg Ulcer
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds
This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.
- Trial name
- SPACE (NCT05666570)
- Testing
- Avelle NPWT
- Where
- Colombia
- Sponsor
- ConvaTec Inc.
Overactive Bladder
Overactive Bladder Posterior Tibial Implantable MIcro STimulator - 1
Interventional, Prospective, Open Label study
- Trial name
- OPTIMIST-1 (NCT03019094)
- Testing
- The RENOVA tibial nerve stimulation system
- Sponsor
- BlueWind Medical
Procedural Sedation, Gastrointestinal Endoscopy
SED Pack: Safety and Performance of a Medical Device Software for Predictive Monitoring During Sedation
The SED-PACK study is a prospective, observational, single-center clinical investigation evaluating the clinical performance and safety of SED Pack, a Medical Device Software (MDSW) developed by Predictheon Medical S.L., in a…
- Trial name
- NCT07749781
- Where
- Spain
- Volunteers
- 120 people
- Sponsor
- Predictheon Medical, S.L.
Vocal Fold Paresis, Laryngeal Dystonia
Monitoring of the Safety and the Performance of the Endoscopic Cap Electrode (ECE50)
The objective of this registry is to confirm the safety and the performance of the ECE50 in medical routine by collecting data.
- Trial name
- ECE50 (NCT05245942)
- Where
- Austria
- Volunteers
- 384 people
- Sponsor
- MED-EL Elektromedizinische Geräte GmbH
Acute Myocardial Infarction (AMI), Asystole
SPIKE FLOW Endocardial Lead Safety and Performance Study
The objective of this study is to assess the safety and performance of the SPIKE FLOW endocardial lead. Primary objectives are to assess: safety in terms of freedom from Serious Adverse Events(SADEs); performance in terms of Mean…
- Conditions
- Acute Myocardial Infarction (AMI), Asystole, Bradycardia, AV Block
- Trial name
- SPIKE FLOW (NCT07820072)
- Testing
- Lead insertion, lead removal
- Where
- 3 sites in Italy
- Volunteers
- 131 people
- Sponsor
- FIAB SpA
Keratoconus
Performance and Safety Assessment of T4020 in Managing Corneal Epithelial Defect Following Epi-off Accelerated Crosslinking
The purpose of this study is to assess the performance and safety of T4020 versus saline solution.
- Trial name
- NCT02979054
- Testing
- T4020
- Where
- 4 sites in Bulgaria, France and 2 more
- Volunteers
- 157 people
- Sponsor
- Laboratoires Thea
Hernia, Inguinal
Safety and Performance of the OTTAVA System in Participants Undergoing Inguinal Hernia Repair
The purpose of this study is to assess safety and performance of the OTTAVA System, through 30 days postoperative, in participants undergoing robotic-assisted inguinal hernia repair (IHR).
- Trial name
- TEMPO (NCT07298317)
- Testing
- OTTAVA Robotic System
- Where
- 4 sites in United States
- Volunteers
- 30 people
- Sponsor
- Auris Health, Inc.
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
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