Clinical trials: High Risk Surgery
Intraocular Pressure
2311 TURGOR Study -Surgical Efficiency and Postoperative Corneal Clarity With Near Physiologic vs High IOP Settings
The study aims to investigate whether adjusting intraocular pressure (IOP) settings to near physiologic levels during cataract surgery could potentially lead to better surgical outcomes, particularly in terms of corneal clarity…
- Trial name
- NCT07144644
- Testing
- Adjusting intraocular pressure (IOP) settings
- Where
- United States
- Volunteers
- 81 people
- Sponsor
- Research Insight LLC
Vulvar Diseases, HPV Infection
Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2/3)
This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2/3).
- Conditions
- Vulvar Diseases, HPV Infection, Vulvar HSIL, Pre-Cancerous Dysplasia
- Trial name
- ART-VIN IIB (NCT06075264)
- Testing
- Artesunate ointment
- Where
- 5 sites in United States
- Volunteers
- 27 people
- Sponsor
- Frantz Viral Therapeutics, LLC
Breast Neoplasms
Treatment of Larotaxel/Docetaxel, +/- Trastuzumab, After Anthracycline-cyclophosphamide in Breast Cancer Patients
The primary objective of this study is to assess the pathological Complete Response (pCR) rate by treatment arm (according to Chevallier criteria).
- Trial name
- SATIN (NCT00485979)
- Testing
- larotaxel (XRP9881), docetaxel, trastuzumab
- Where
- 8 sites in Belgium, Brazil and 6 more
- Volunteers
- 330 people
- Sponsor
- Sanofi
Colorectal Cancer Stage II, Colorectal Cancer Stage III
Epidemiological Study to Monitor Study Participants With Resected Stage II (High Risk) or Stage III Colorectal Cancer for Circulating Tumor DNA Before, During and After Their Treatment With Adjuvant Chemotherapy
This is a multi-site epidemiological study designed to monitor circulating tumor DNA (ctDNA) status in participants with Stage II (high risk)/III colorectal cancer (CRC) following resection/prior to adjuvant chemotherapy (AdCTx)…
- Trial name
- NCT04813627
- Testing
- Regular blood sample collection for ctDNA assessment
- Where
- 74 sites in United States, Belgium and 2 more
- Volunteers
- 2,079 people
- Sponsor
- BioNTech SE
High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention
Evaluation of Image Quality and Safety of the MyVeo Surgical Visualization Headset During Standard Neurosurgical and Reconstructive Procedures Using Compatible Microscopes.
This study looks at how well the MyVeo surgical visualization headset works during routine surgeries. MyVeo is a wearable device that helps surgeons see the surgical area in high detail, including blood flow and tissue…
- Conditions
- High-Grade Glioma (WHO III-IV), Cerebral Vascular Conditions Requiring Surgical Intervention, Conditions Requiring Plastic and Reconstructive Surgery
- Trial name
- IMED-MYVEO (NCT07164053)
- Testing
- MyVeo is an all-in-one surgical visualization headset used with compatible surgical microscopes and other medical imaging systems in the area of neurosurgery, ENT, spine, plastic and reconstructive su
- Where
- 2 sites in Spain, Switzerland
- Volunteers
- 32 people
- Sponsor
- Leica Microsystems (Schweiz) AG
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
Cardiac Surgery
QPI-1002 Phase 3 for Prevention of Major Adverse Kidney Events (MAKE) in Subjects at High Risk for AKI Following Cardiac Surgery
This trial is designed to evaluate QPI-1002 versus placebo for the prevention of Major Adverse Kidney Events (MAKE) in subjects at high risk for acute kidney injury following cardiac surgery.
- Trial name
- NCT03510897
- Testing
- teprasiran
- Where
- 104 sites in United States, Australia and 9 more
- Volunteers
- 1,043 people
- Sponsor
- Quark Pharmaceuticals
Cardiothoracic Surgery, Vascular Surgery
A Safety and Efficacy Trial of Multiple Dosing Regimens of ABT-719 for the Prevention of Acute Kidney Injury in Subjects Undergoing High Risk Surgery
This study will evaluate the safety and efficacy of ABT-719 in patients undergoing high risk major surgery.
- Trial name
- NCT01897519
- Testing
- ABT-719
- Where
- 23 sites in United States, Denmark
- Volunteers
- 56 people
- Sponsor
- AbbVie
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
Glioma, Malignant, High Grade Glioma
Convection-enhanced Delivery of OS2966 for Patients With High-grade Glioma Undergoing a Surgical Resection
The primary goal of this Phase 1 study is to determine if a new investigational drug, OS2966, when delivered directly to the brain of adult participants with recurrent/progressive high-grade glioma (HGG) is safe and well…
- Conditions
- Glioma, Malignant, High Grade Glioma, Glioblastoma, Glioblastoma Multiforme
- Trial name
- NCT04608812
- Testing
- OS2966, Gadoteridol
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- OncoSynergy, Inc.
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
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Cardiac Surgery
Evaluation of Renal Function in Subjects Who Had Undergone Cardiac Surgery
To evaluate the differences between serum cystatin C based estimated glomerular filtration rate (eGFRcys), serum creatinine based eGFR (eGFRcreat) and measured glomerular filtration rate (mGFR) in subjects at high risk for acute…
- Trial name
- NCT04654221
- Testing
- mGFR by iohexol clearance
- Where
- 6 sites in United States
- Volunteers
- 16 people
- Sponsor
- Quark Pharmaceuticals
Kidney Injury Following Open-Chest Cardiac Surgery
A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery
The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury.
- Trial name
- POINTER (NCT06475274)
- Testing
- RMC-035
- Where
- 19 sites in Canada, Czechia and 2 more
- Volunteers
- 170 people
- Sponsor
- Guard Therapeutics AB
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.
Non-cardiac Surgical, Intensive Care Unit (ICU)
The HIgh-fidelity Hydraulic couPling Upper-arm Cuff Assessment of Limits, Safety, and Effectiveness (HIPULSE) Trial
The purpose of this study is to compare measurements of blood pressure (BP) and fluid responsiveness between the Philips AMC and invasive radial arterial line in surgical patients.
- Trial name
- HIPULSE (NCT06895590)
- Testing
- Philips Advanced Monitoring Cuff (i.e. AMC)
- Where
- 4 sites in United States, Germany
- Volunteers
- 205 people
- Sponsor
- Philips Clinical & Medical Affairs Global
Epithelial Ovarian Cancer
WoO: Window of Opportunity Trial of Olaparib and Durvalumab in Histologically Proven EOC
This is a multi-center, prospective, open-label, phase II trial. Patients with suspected advanced ovarian cancer planned to undergo diagnostic laparoscopy for histologic confirmation and evaluation of disease spread will be…
- Trial name
- WoO (NCT04644289)
- Testing
- olaparib, durvalumab
- Where
- 6 sites in Germany
- Volunteers
- 60 people
- Sponsor
- AGO Research GmbH
Post-surgical Oral Wounds, Oral Cavity Surgery
Evaluation of the Performance and Safety of a Linear Hyaluronic Acid-Based Medical Device in the Treatment of Surgical Wounds in the Oral Cavity.
The PR-DENT study is an interventional, single-center, controlled clinical investigation aimed at evaluating the clinical performance and safety of a Class III medical device based on linear hyaluronic acid for the treatment of…
- Conditions
- Post-surgical Oral Wounds, Oral Cavity Surgery, Wound Healing/Regeneration, Dental Extraction Sites
- Trial name
- PR-DENT (NCT07421934)
- Testing
- Intervention: Linear Hyaluronic Acid (Gumblast), Control: Standard Surgical Procedure
- Where
- Italy
- Volunteers
- 28 people
- Sponsor
- The Wave Innovation Group s.r.l.
Mitral Regurgitation
Valveclip® Transcatheter Mitral Valve Repair Study
The purpose of this clinical trial is to evaluate the effectiveness and safety of the transcatheter mitral valve repair system in the treatment of patients with moderate or above degenerative mitral regurgitation.
- Trial name
- NCT05021614
- Testing
- Valveclip® Transcatheter mitral valve repair
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Shanghai NewMed Medical Co., Ltd.