Clinical trials: High Risk Surgery
Moderate to High-risk Noncardiac Surgery
SMART TRENDS Study
A multicenter, interventional, feasibility comparison with historical controls
- Trial name
- NCT05957406
- Testing
- Acumen HPI Smart Alerts and Smart Trends Software, The HemoSphere advanced monitoring platform with Acumen HPI software, and Acumen IQ sensor and Acumen IQ cuff
- Where
- 8 sites in United States
- Volunteers
- 296 people
- Sponsor
- Becton, Dickinson and Company
Mitral Regurgitation
HighFLO Study - HighLife Trans-septal Mitral Valve Replacement (TSMVR) Feasibility Study of the Open Cell CLARITY Valve
Feasibility, safety and performance of the HighLife CLARITY TSMV and its delivery system
- Trial name
- HighFLO (NCT04888247)
- Testing
- CLARITY
- Where
- 14 sites in Australia, Belgium and 4 more
- Volunteers
- 30 people
- Sponsor
- HighLife SAS
Mitral Valve Regurgitation
Mi-thos® Transcatheter Mitral Valve Replacement Study
To evaluate the safety and performance of the Mi-thos® Mitral Heart Valve with the Mi-thos® Transcatheter Delivery System.
- Trial name
- NCT04195984
- Testing
- Mi-thos® valve and transapical delivery system
- Where
- 3 sites in China
- Volunteers
- 122 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.
Mitral Regurgitation
Cardiovalve Transfemoral System - FIM Study
The Cardiovalve system is a replacement valve delivered through a transfemoral access and transseptal approach and is intended for symptomatic patients with Mitral regurgitation for whom surgical options are not feasible.
- Trial name
- NCT03958773
- Testing
- Cardiovalve transfemoral Mitral valve system
- Where
- Lithuania
- Volunteers
- 10 people
- Sponsor
- Cardiovalve Ltd.
Carcinoma, Hepatocellular
A Study of Atezolizumab Plus Bevacizumab Versus Active Surveillance as Adjuvant Therapy in Patients With Hepatocellular Carcinoma at High Risk of Recurrence After Surgical Resection or Ablation
This study will evaluate the efficacy and safety of adjuvant therapy with atezolizumab plus bevacizumab compared with active surveillance in participants with completely resected or ablated hepatocellular carcinoma (HCC) who are…
- Trial name
- IMbrave050 (NCT04102098)
- Testing
- Atezolizumab, Bevacizumab
- Where
- 134 sites in United States, Australia and 24 more
- Volunteers
- 668 people
- Sponsor
- Hoffmann-La Roche
Nipple Sparing Mastectomy
Robotic-Assisted da Vinci System Prophylactic Nipple-Sparing Mastectomy
This study evaluates the safety and effectiveness of the da Vinci Surgical Systems in prophylactic Nipple Sparing Mastectomy procedures.
- Trial name
- NCT03892980
- Testing
- Nipple-Sparing Mastectomy
- Where
- 6 sites in United States
- Volunteers
- 145 people
- Sponsor
- Intuitive Surgical
Cardiac Surgery, Sternal Wound Infection
Safety and Efficacy of an Antibiotic Implant in Cardiac Surgical Subjects at Higher Risk for Sternal Wound Infection
The purpose of this study is to determine whether the gentamicin-collagen sponge is safe and effective in preventing sternal wound infections in patients undergoing cardiac surgery who are at a greater risk of developing sternal…
- Trial name
- NCT00600483
- Testing
- gentamicin-collagen sponge dipped in saline
- Where
- 43 sites in United States
- Volunteers
- 1,502 people
- Sponsor
- Innocoll
Reduction in the Initial Length of Stay
An Evaluation of Multisense® to Ensure a Safe Return Home Following High-risk Gastrointestinal Surgery, Compared With Standard Care.
The SENSE-ECO study is a prospective, randomized trial of 490 high-risk patients designed to show that the MultiSense® remote monitoring patch safely reduces hospital stays following major digestive surgery.
- Trial name
- SENSE-ECO (NCT07552805)
- Testing
- Monitoring by MultiSense®
- Where
- 9 sites in France
- Volunteers
- 490 people
- Sponsor
- Rhythm Diagnostic Systems
Coronary Artery Disease, Unstable Angina
Restore EF Observational Study
A multi-center, prospective, observational, non-interventional single arm, study of the intermediate-term clinical outcomes collected from electronic health records of high-risk patients which have previously undergone standard…
- Conditions
- Coronary Artery Disease, Unstable Angina, Angina, Stable, NSTEMI - Non-ST Segment Elevation MI
- Trial name
- NCT04648306
- Testing
- Prophylactic Impella support for a non-emergent PCI
- Where
- 21 sites in United States
- Volunteers
- 406 people
- Sponsor
- Abiomed Inc.
Intraocular Lens Replacement, Intraoperative Floppy Iris Syndrome
Intraoperative Floppy Iris Syndrome Undergoing Intraocular Lens Replacement Surgery
The purpose of this study is to evaluate the effect of OMS302 on the signs of Intraoperative Floppy Iris Syndrome in patients at risk.
- Trial name
- NCT02093689
- Testing
- Part 1 OMS302, Part 2 OMS302
- Where
- 2 sites in Austria, Germany
- Volunteers
- 18 people
- Sponsor
- Omeros Corporation
Prostate Cancer
A Phase 2 Study With MIP-1404 in Men With High-Risk PC Scheduled for RP and EPLND Compared to Histopathology
This was a multicenter, multi-reader, open-label, Phase 2 study assessing the safety and performance characteristics of MIP 1404 imaging in the detection of prostate gland and pelvic lymph node cancer.
- Trial name
- NCT01667536
- Testing
- Drug: 99mTc-MIP-1404
- Where
- 35 sites in United States, Belgium and 6 more
- Volunteers
- 105 people
- Sponsor
- Molecular Insight Pharmaceuticals, Inc.
Severe Aortic Stenosis
Colibri Transcatheter Aortic Heart Valve System Study
The Colibri Heart Valve clinical investigation ("COL-01") is a prospective, multicenter, exploratory single arm and controlled clinical investigation compared to recent historical results.
- Trial name
- NCT04029844
- Testing
- Colibri TAVI System
- Where
- 5 sites in France, United Kingdom
- Volunteers
- 30 people
- Sponsor
- Colibri Heart Valve LLC
Joint Contractures, Total Knee Anthroplasty
Knee Flexionater to Avoid Motion Restoring Surgery
The goal of this clinical trial is to learn whether adding a stretching device to standard physical therapy can help people regain knee bending after total knee replacement surgery.
- Conditions
- Joint Contractures, Total Knee Anthroplasty, Knee Arthrofibrosis
- Trial name
- NCT07454356
- Testing
- Hydraulic high Intensity Stretch Device, Standard Physical Therapy
- Where
- United States
- Volunteers
- 150 people
- Sponsor
- Ermi LLC
Chronic Pain
Algovita Spinal Cord Stimulation System Hi-Fi Study
The objective of this study is to obtain post-market clinical outcome data for the Algovita SCS System when used on-label, according to the applicable directions for use, using high fidelity tonic stimulation at either ultra-high…
- Trial name
- NCT03622866
- Testing
- Ultra-high pulse width stimulation, Traditional pulse width stimulation
- Where
- 10 sites in United States
- Volunteers
- 20 people
- Sponsor
- Nuvectra
Carotid Artery Diseases, Stroke
Boston Scientific Embolic Protection, Inc. (EPI): A Carotid Stenting Trial for High-Risk Surgical Patients (BEACH)
The purpose of this study is to determine whether morbidity and mortality for high-risk surgical patients treated with the Carotid Wallstent in conjunction with the FilterWire EX and EZ System distal protection device will be…
- Conditions
- Carotid Artery Diseases, Stroke, Cerebral Arteriosclerosis
- Trial name
- BEACH (NCT00316108)
- Testing
- WALLSTENT® Endoprosthesis™
- Where
- 50 sites in United States
- Volunteers
- 747 people
- Sponsor
- Boston Scientific Corporation
Carotid Artery Disease
Proximal Protection With The Mo.Ma Device During Carotid Stenting
The objective of the ARMOUR study is to evaluate the safety and effectiveness of the Mo.Ma proximal flow blockage cerebral protection device for patients at high surgical risk for carotid endarterectomy who undergo carotid artery…
- Trial name
- ARMOUR (NCT00744523)
- Testing
- Mo.Ma cerebral protection device
- Where
- 2 sites in United States
- Volunteers
- 262 people
- Sponsor
- Medtronic Endovascular
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
Surgical Wound Healing, Lower Extremity
Oxygen for Vascular Incisional Healing
The purpose of this clinical trial is to evaluate Transdermal Continuous Oxygen Therapy (TCOT) as an adjunct to surgical wound healing in subjects undergoing vascular surgery for lower extremity arterial occlusive disease.
- Conditions
- Surgical Wound Healing, Lower Extremity, Revascularization, Incision
- Trial name
- NCT03746132
- Testing
- EPIFLO
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Neogenix, LLC dba Ogenix
Transcatheter Aortic Valve Implantation
NVT ALLEGRA TAVI System TF in Failing Calcified Aortic Heart Valves in a Real-world Patient Population
The study collects real-world data of patients who were treated with the ALLEGRA TAVI System TF and evaluates early and midterm clinical and quality of life outcome.
- Trial name
- FOLLOW (NCT03613246)
- Where
- 14 sites in Finland, Germany and 4 more
- Volunteers
- 346 people
- Sponsor
- NVT GmbH
Brain Tumour, High Grade Glioma
SonoClear Acoustic Coupling Fluid (ACF) Mimicking Brain Tissue
The objective of this clinical investigation is to assess the safety and performance of the SonoClear Acoustic Coupling Fluid (ACF).
- Conditions
- Brain Tumour, High Grade Glioma, Low-grade Glioma, Glioblastoma
- Trial name
- NCT04734444
- Testing
- SonoClear ACF
- Where
- 4 sites in Germany, Italy and 1 more
- Volunteers
- 45 people
- Sponsor
- SonoClear AS