Clinical trials: High Risk Surgery
Non-small Cell Lung Cancer
Phase II of Neoadjuvant and Adjuvant Capmatinib in NSCLC
This study was planned to determine if neoadjuvant capmatinib could improve the major pathological response (MPR) in patients with Stage IB-IIIA, N2 and selected IIIB (T3N2 or T4N2) lung cancers with Mesenchymal Epithelial…
- Trial name
- Geometry-N (NCT04926831)
- Testing
- capmatinib
- Where
- 6 sites in United States
- Volunteers
- 4 people
- Sponsor
- Novartis Pharmaceuticals
Symptomatic Severe Aortic Stenosis
FlexNav EU CE Mark Study
The purpose of this clinical investigation is to characterize the safety of the next-generation FlexNav™ Delivery System for transfemoral implantation of the Portico™ Transcatheter Aortic Heart Valve in symptomatic severe aortic…
- Trial name
- NCT03724812
- Testing
- Portico Valve and FlexNav™ Delivery System
- Where
- 6 sites in Denmark, Italy and 2 more
- Volunteers
- 46 people
- Sponsor
- Abbott Medical Devices
Melanoma
A Study of Vemurafenib Adjuvant Therapy in Participants With Surgically Resected Cutaneous BRAF-Mutant Melanoma
This multicenter, randomized, double-blind, placebo-controlled study will evaluate the efficacy and safety of vemurafenib in participants with completely resected, cutaneous BRAF mutation-positive melanoma at high risk for…
- Trial name
- BRIM8 (NCT01667419)
- Testing
- Vemurafenib
- Where
- 207 sites in United States, Argentina and 27 more
- Volunteers
- 498 people
- Sponsor
- Hoffmann-La Roche
Arthroscopic Surgical Treatment of High-grade (>50%) Partialthickness
Treatment of Partial-Thickness Rotator Cuff Tears
The goal of this clinical trial is to demonstrate that REGENETEN is superior to standard repair techniques when surgically treating high-grade (>50%) partial-thickness tears.
- Trial name
- REGEN PUB 2018 (NCT03734536)
- Testing
- REGENETEN™ Bioinductive Implant, Arthroscopic repair of the high-grade (>50%) partial-thickness
- Where
- 10 sites in United States
- Volunteers
- 168 people
- Sponsor
- Smith & Nephew, Inc.
Mitral Valve Regurgitation
Early Feasibility Study of the Neovasc Tiara™ Mitral Valve System
The purpose of this study is to evaluate the safety and initial performance of the Neovasc Tiara Mitral Transcatheter Heart Valve with the Tiara Transapical Delivery System.
- Trial name
- TIARA-I (NCT02276547)
- Testing
- Mitral valve replacement
- Where
- 10 sites in United States, Belgium and 1 more
- Volunteers
- 27 people
- Sponsor
- Shockwave Medical, Inc.
Coronary Artery Bypass, Myocardial Infarction
The Effect Of Acadesine On Reducing Cardiovascular and Cerebrovascular Adverse Events In Coronary Artery Bypass Graft (CABG) Surgery (Study P05633 AM1)(TERMINATED)
The purpose of this study is to determine whether acadesine is effective in reducing the cardiovascular and cerebrovascular adverse events in high-risk participants undergoing CABG surgery.
- Conditions
- Coronary Artery Bypass, Myocardial Infarction, Ventricular Dysfunction, Left, Stroke
- Trial name
- RED-CABG (NCT00872001)
- Testing
- Acadesine, Normal Saline
- Volunteers
- 3,080 people
- Sponsor
- Merck Sharp & Dohme LLC
Various Advanced Cancer
An Investigational Immuno-therapy Study of Nivolumab, Compared to Placebo, in Patients With Bladder or Upper Urinary Tract Cancer, Following Surgery to Remove the Cancer
The purpose of this study is to determine the effectiveness and safety of Nivolumab compared to placebo in participants who have undergone radical surgery for invasive urothelial cancer.
- Trial name
- CheckMate 274 (NCT02632409)
- Testing
- Nivolumab
- Where
- 188 sites in United States, Argentina and 28 more
- Volunteers
- 709 people
- Sponsor
- Bristol-Myers Squibb
Kidney Cancer
Monoclonal Antibody Therapy (Rencarex®) in Treating Patients Who Have Undergone Surgery for Non-metastatic Kidney Cancer
RATIONALE: Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells.
- Trial name
- NCT00087022
- Testing
- girentuximab
- Where
- 56 sites in United States, Argentina and 2 more
- Volunteers
- 864 people
- Sponsor
- Heidelberg Pharma AG
Carcinoma, Squamous Cell
Pembrolizumab (MK-3475) Versus Placebo Following Surgery and Radiation in Participants With Locally Advanced Cutaneous Squamous Cell Carcinoma (MK-3475-630/KEYNOTE-630)
This is a randomized, double-blind, study that compares pembrolizumab (MK-3475) with placebo given as adjuvant therapy in participants with high-risk locally advanced cutaneous squamous cell carcinoma (LA cSCC) that have…
- Trial name
- NCT03833167
- Testing
- Pembrolizumab
- Where
- 181 sites in United States, Argentina and 22 more
- Volunteers
- 450 people
- Sponsor
- Merck Sharp & Dohme LLC
Aortic Valve Stenosis
Clinical Evaluation of Percutaneous Implantation of the Medtronic CoreValve Aortic Valve Prosthesis (18Fr-Study)
The investigation concerns a prospective, multicenter, single arm safety and performance study evaluating the Medtronic CoreValve system.
- Trial name
- NCT01051518
- Testing
- Medtronic CoreValve System
- Where
- 9 sites in Canada, Germany and 2 more
- Volunteers
- 126 people
- Sponsor
- Medtronic Cardiac Rhythm and Heart Failure
Acute Kidney Injury
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery.
- Trial name
- AKITA (NCT05126303)
- Testing
- RMC-035
- Where
- 29 sites in United States, Canada and 3 more
- Volunteers
- 177 people
- Sponsor
- Guard Therapeutics AB
Sternal Wound Infection, Sternal Non-union
Evaluation of Primary Plating in Sternotomy Patients for Osteosynthesis and Pain
The goal of this study is to evaluate sternal osteosynthesis, chest wall pain and return to normal activity in open heart surgery patients who had their breast bone closed either with wires or plates.
- Conditions
- Sternal Wound Infection, Sternal Non-union, Pain, Mediastinitis
- Trial name
- RESTORE (NCT00819286)
- Testing
- SternaLock Rigid Fixation Plates, wire (control)
- Where
- 6 sites in United States, Germany
- Volunteers
- 140 people
- Sponsor
- Zimmer Biomet
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
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
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.
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
Symptomatic Severe Aortic Stenosis
Portico Next Generation Approval Study
The purpose of this clinical study is to evaluate the acute safety and effectiveness of the next-generation Navitor (Portico™ NG) Transcatheter Aortic Heart Valve as assessed by the rate of all-cause mortality at 30 days and the…
- Trial name
- NCT04011722
- Testing
- Portico™ NG (Navitor) Valve and FlexNav™ Delivery System, Navitor Titan Valve (35mm) Valve and Large FlexNav™ Delivery System
- Where
- 28 sites in United States, Australia and 3 more
- Volunteers
- 333 people
- Sponsor
- Abbott Medical Devices
Carcinoma, Transitional Cell
A Study of Atezolizumab Versus Observation as Adjuvant Therapy in Participants With High-Risk Muscle-Invasive Urothelial Carcinoma (UC) After Surgical Resection
This Phase III, open-label, randomized, multicenter study is to evaluate the efficacy and safety of adjuvant treatment with atezolizumab compared with observation in participants with muscle-invasive UC who are at high risk for…
- Trial name
- IMvigor010 (NCT02450331)
- Testing
- Atezolizumab
- Where
- 186 sites in United States, Australia and 22 more
- Volunteers
- 809 people
- Sponsor
- Hoffmann-La Roche
Moderate to High-risk Noncardiac Surgery
Hypotension Prediction Index (HPI) SMART-BP Trial
A multicenter, randomized comparison of intraoperative hemodynamic management with or without a protocolized strategy utilizing Hypotension Prediction Index (HPI) software guidance during moderate-to-high-risk noncardiac surgery.
- Trial name
- NCT05105477
- Testing
- AcumenTM HPI Software Feature, Non-protocolized Standard of Care
- Where
- 11 sites in United States
- Volunteers
- 407 people
- Sponsor
- Edwards Lifesciences