Clinical trials: Major Surgery, open to volunteers
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.
Severe Aortic Stenosis, Valve-in-valve Procedures
A Clinical Trial Assessing the Safety and Effectiveness of the DurAVR® THV System
Prospective, randomized, controlled, multicenter, international study. Up to 1054 subjects with a severe native calcific aortic stenosis who are determined by the local Heart Team to have an indication for Transcatheter Aortic…
- Trial name
- PARADIGM (NCT07194265)
- Testing
- TAVR with DurAVR® THV, TAVR with SAPIEN THV series or the Evolut THV series
- Where
- Denmark
- Volunteers
- 1,650 people
- Sponsor
- Anteris Technologies Ltd.
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
Post Operative Pain, Acute
A Study of Combogesic® 325 in Adolescent Patients With Moderate to Severe Postoperative Pain Associated With Orthopedic Surgery
Combogesic® 325 contains a combination of ibuprofen and acetaminophen. The purpose of this study is to compare the pain relief effects of Combogesic® 325mg and acetaminophen and to evaluate the safety of Combogesic® 325mg in…
- Trial name
- NCT07225140
- Testing
- Combogesic® tablets, Acetaminophen 500mg
- Where
- United States
- Volunteers
- 180 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
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.
Major Depressive Disorder, MDD
Operation of Brain Stimulation Equipment Under Remote Viewing Effectiveness Registry
The goal of this observational study is to record and analyze factors putatively affecting the clinical outcomes among patients undergoing transcranial magnetic stimulation (TMS) treatment for major depressive disorder (MDD) or…
- Conditions
- Major Depressive Disorder, MDD, Generalized Anxiety Disorder, GAD
- Trial name
- OBSERVER (NCT06512324)
- Testing
- Ampa One TMS System
- Where
- 2 sites in United States
- Volunteers
- 5,000 people
- Sponsor
- Biomedical Discoveries and Neuroscientific Foundations LLC
Moderate to Severe Acute Postoperative Pain
Evaluate the Safety and Efficacy of HL-1186 Tablet for Moderate to Severe Acute Pain After Surgery
This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for moderate to severe acute pain after surgery.
- Trial name
- NCT07147049
- Testing
- HL-1186
- Where
- China
- Volunteers
- 72 people
- Sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
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
Aortic Stenosis, Bicuspid Aortic Valve (BAV)
TAVR vs. SAVR Study of VitaFlow Liberty® for Severe BAV Stenosis
To evaluate the safety and effectiveness of the Transcatheter aortic valve and retrievable delivery system (VitaFlow Liberty®) for the treatment of severe bicuspid aortic valve (BAV) stenosis.
- Trial name
- PROMIS-BAV (NCT06597188)
- Testing
- VitaFlow Liberty, Commercially available surgical bioprosthetic valve
- Where
- China
- Volunteers
- 452 people
- Sponsor
- Shanghai MicroPort CardioFlow Medtech Co., Ltd.
Moderate to Severe Acute Postoperative Pain
Evaluate the Safety and Efficacy of HL-1186 Tablet for Postoperative Pain Management in Abdominal Surgery
This is a multiple-center, randomized, double-blind, placebo-controlled study design evaluating the safety, efficacy, and pharmacokinetics (PK) parameter of HL-1186 tablet for postoperative pain management in abdominal surgery.
- Trial name
- NCT07311369
- Testing
- HL-1186
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Shanghai Yidian Pharmaceutical Technology Development Co., Ltd.
Glioma, High-Grade Glioma (HGG)
Feasibility Assessment of a Medical Device for Tumour Cell Retention and Radiotherapy Sensitization in Patients With Suspected High-grade Glioma
This is a prospective, multicenter, single-arm, pilot clinical investigation, aimed at evaluating the safety and preliminary efficacy of the GlioHook implant in patients with high-grade glioma undergoing surgical resection…
- Conditions
- Glioma, High-Grade Glioma (HGG), Surgical Resection
- Trial name
- CT-GlioHook (NCT07725640)
- Testing
- GlioHook device
- Where
- 3 sites in Spain
- Volunteers
- 15 people
- Sponsor
- Batea Oncology
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
Ischemia Reperfusion Injury, Cardiac Surgery Associated - Acute Kidney Injury
A Study to Evaluate the Efficacy and Safety of BX-001N in Preventing Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI) and Major Adverse Kidney Events (MAKE)
This is a Randomized, Single-blind, Multi-center, Placebo-controlled, Phase 2a clinical trial of BX-001N to prevent patients from Cardiac Surgery Associated Acute Kidney Injury (CSA-AKI) and subsequent Major Adverse Kidney Events…
- Trial name
- NCT07164833
- Testing
- BX-001N Experimental group 1, BX-001N Experimental group 2
- Where
- 8 sites in South Korea
- Volunteers
- 50 people
- Sponsor
- Bilix Co.,Ltd.
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
Delay in GI Recovery/Postoperative Ileus (POI)
TU-100 for Accelerating GI Recovery After Major Abdominopelvic Surgery (RC & CAWR)
This Phase 2, multicenter, randomized, double-blind, placebo-controlled master protocol study will evaluate the safety and efficacy of TU-100, adjunctive to an Enhanced Recovery After Surgery (ERAS) pathway, for accelerating…
- Trial name
- NCT07765589
- Testing
- TU-100
- Volunteers
- 240 people
- Sponsor
- Tsumura USA
Aortic Stenosis, Aortic Stenosis, Severe
PARTNER 3 Trial - Aortic Valve-in-Valve
This study will assess the safety and effectiveness of the SAPIEN 3/SAPIEN 3 Ultra transcatheter heart valve (THV) in patients with a failing aortic bioprosthetic valve.
- Trial name
- NCT03003299
- Testing
- Edwards SAPIEN 3/SAPIEN 3 Ultra THV
- Where
- 51 sites in United States, Canada
- Volunteers
- 125 people
- Sponsor
- Edwards Lifesciences
Mitral Regurgitation
Expanded Study of the HighLife 28mm Trans-septal Trans-catheter Mitral Valve in Patients With Moderate-severe or Severe Mitral Regurgitation and at High Surgical Risk
to evaluate the safety and performance of the HighLife 28mm transcatheter, trans-septal Mitral Valve in patients with moderate-severe or severe mitral regurgitation who are at high risk for surgical treatment.
- Trial name
- NCT04029363
- Testing
- HighLife Transcatheter Mitral Valve Replacement
- Where
- 50 sites in Australia, Belgium and 5 more
- Volunteers
- 120 people
- Sponsor
- HighLife SAS
Hip or Knee Replacement
CBP-0276 to Reduce Opioid Use in Adults Undergoing Major Orthopedic Surgery
Randomized, double-blind, clinical study to evaluate the safety and efficacy of CBP-0276 at doses of 600 mg/day in reducing opioid use in pain management in adult patients undergoing major orthopedic surgery.
- Trial name
- CBP0276-Opd (NCT07687966)
- Testing
- CBP-0276
- Where
- Mexico
- Volunteers
- 80 people
- Sponsor
- Clarent Biopharma, 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
Ovarian Cancer, HGSOC
Study of CryptiVax-1001 in Maintenance Setting for Advanced Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer
Ovarian, fallopian tube, or primary peritoneal cancer, collectively referred to as ovarian cancer, remains the deadliest type of gynaecological cancer.
- Conditions
- Ovarian Cancer, HGSOC, HGS Ovarian, Fallopian Tube or Primary Peritoneal Cancer
- Trial name
- OVACT (NCT07665515)
- Testing
- CryptiVax-1001
- Where
- 10 sites in United Kingdom
- Volunteers
- 50 people
- Sponsor
- Epitopea Ltd