Clinical trials: Procedure
Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation
OPTION-EMEA Clinical Trial
The OPTION-EMEA post-market study is intended to gather real world clinical data for patients undergoing AF ablation with the FARAPULSE™ Pulsed Field Ablation (PFA) System and subsequent left atrial appendage closure (LAAC) with…
- Conditions
- Atrial Fibrillation (AF), Stroke Prevention in Patients With Atrial Fibrillation, Left Atrial Appendage Closure, Pulsed Field Ablation
- Trial name
- OPTION-EMEA (NCT07349121)
- Testing
- Concomitant pulsed field ablation (PFA) and left atrial appendage closure (LAAC) during one interventional case, Concomitant Pulsed Field Ablation and Left Atrial Appendage Closure
- Where
- 11 sites in Belgium, Croatia and 3 more
- Volunteers
- 500 people
- Sponsor
- Boston Scientific Corporation
Concomitant Procedures, Atrial Fibrillation
cOncomitant Left Atrial aPpendage Closure and Pulsed Field ablaTION-Asia
Subjects enrolled in the OPTION-A study will be clinically indicated for atrial fibrillation (AF) ablation procedure with the FARAPULSE™ PFA system and treatment with WATCHMAN LAAC Device, per physician's medical judgement and…
- Conditions
- Concomitant Procedures, Atrial Fibrillation, PFA, LAAC
- Trial name
- OPTION-A (NCT06686485)
- Testing
- FARAPULSE™ PFA system and WATCHMAN LAAC Delivery Systems
- Where
- 37 sites in China, Hong Kong and 4 more
- Volunteers
- 433 people
- Sponsor
- Boston Scientific Corporation
Cardiac Rhythm Disorders, Urological Disorders
Product Surveillance Registry
The purpose of the Registry is to provide continuing evaluation and periodic reporting of safety and effectiveness of Medtronic market-released products.
- Conditions
- Cardiac Rhythm Disorders, Urological Disorders, Neurological Disorders, Cardiovascular Disorders
- Trial name
- PSR (NCT01524276)
- Where
- 402 sites in United States, Argentina and 39 more
- Volunteers
- 100,000 people
- Sponsor
- Medtronic
Oral Surgical Procedures
Plenum® Osshp in Maxillary Sinus Elevation Surgery
The aim of this study is to qualitatively and quantitatively evaluate bone neoformation in maxillary sinus lift surgery filled with Plenum® Oss hp, compared to filling with autogenous bone, and to verify the association of…
- Trial name
- NCT06136143
- Testing
- Group 1: Autogenous bone graft, Group 2: Plenum® Osshp, Group 3: Plenum® Osshp; + i-PRF
- Where
- Brazil
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- M3 Health
Oral Surgical Procedures
Retrospective Observational Study of Implant-supported Restorations With Dental Implants.
This retrospective study aims to value the bone loss and the success and survival of the dental implants produced by additive manufacturing installed in an area grafted with Plenum® Osshp (synthetic bone graft).
- Trial name
- NCT06154057
- Testing
- Dental Implants installed in an grafted area (sinus lifting), Dental Implants installed in an grafted area (ridge augmentation), Dental Implants installed in an grafted area (extraction sites)
- Where
- Brazil
- Volunteers
- 100 people, healthy volunteers welcome
- Sponsor
- M3 Health
ENT Disorder, Nasal Procedures
Pharmacokinetics, Safety, and Tolerability Study of GOPRELTO® Nasal Solution and NUMBRINO™ Nasal Solution
The purpose of this study is to assess the pharmacokinetic (PK) properties, safety and tolerability following a single dose administration of GOPRELTO® or NUMBRINO™ as an anesthetic for diagnostic procedures and surgeries on or…
- Conditions
- ENT Disorder, Nasal Procedures, Nasal Anesthesia, Nasal Mucosa Surgery
- Trial name
- NCT04792034
- Testing
- Cocaine Hydrochloride Nasal Solution
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- LXO Ireland
Surgical Procedure, Unspecified, Intensive Care Units (ICUs)
Continuous Connected Patient Care (CCPC), a Pilot Testing a Novel Device for Continuous Vitals Monitoring - Department of Anesthesia at PHC
To confirm feasibility and accessibility of the CCPC Platform (Oxymotion, Bridge Health Solutions medication adherence software, CloudDX home kit) in two different environments - in hospital and at-home, in patients undergoing…
- Trial name
- NCT06638073
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Medtronic - MITG
Benign Prostate Hypertrophy(BPH), Renal Calculi
Stone and Laser Therapies Post-Market Study (SALT)
The objective of the SALT Study is to obtain post-market safety and device performance data for Boston Scientific's Stone and BPH study devices used during a diagnostic and/or therapeutic urinary tract procedure (e.g.…
- Conditions
- Benign Prostate Hypertrophy(BPH), Renal Calculi, Ureteral Stones, Kidney Stones, Calculi, Urinary
- Trial name
- SALT (NCT06982235)
- Testing
- Ureteroscope system, Laser system
- Where
- 5 sites in United States
- Volunteers
- 238 people
- Sponsor
- Boston Scientific Corporation
Bowel Cleansing Prior to Clinical Procedures
A Study to Investigate Bowel Cleansing With PLENVU® Compared to Sodium Picosulfate in Participants Aged 1 to < 18 Years of Age in Preparation for Colonoscopy
The purpose of the study is to assess the efficacy, safety and tolerability of PLENVU® by measuring its bowel cleansing success rate compared to sodium picosulfate in paediatric participants aged less than 18 years who are…
- Trial name
- CLARITY (NCT07218523)
- Testing
- PLENVU®, Sodium picosulfate
- Where
- 46 sites in Belgium, Croatia and 8 more
- Volunteers
- 212 people
- Sponsor
- Norgine
Surgery, Orthognathic Surgery
Prospective Study to Evaluate the Performance and Safety of Personalized Implants in Cranio-Maxillofacial (CMF) Surgery Indicated for Orthognathic Surgery
With the digital age, guided surgery and cases of fully computer-assisted surgeries via 3D printing guides and preformed plates are booming.
- Conditions
- Surgery, Orthognathic Surgery, Orthognathic Surgical Procedures
- Trial name
- NCT05073757
- Testing
- Custom-made guides and plates
- Where
- 4 sites in Belgium, France
- Volunteers
- 56 people
- Sponsor
- Global D
Colon Procedures, Bowel Resection
MIRA Registry Study: Post Market Surveillance Using the MIRA Surgical System
The purpose of the MIRA Surgical System Registry is to accumulate and evaluate real world evidence experience as part of post-market surveillance using the MIRA Surgical System.
- Trial name
- NCT06856707
- Testing
- Use of the MIRA Surgical System during surgery
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Virtual Incision Corporation
Surgical Procedures, Operative
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
The purpose of this study is to compare how well the ETHICON™ 4000 Stapler works as compared to the standard stapling devices by assessing how often air leaks and bleeding along the staple line occur during lung and stomach…
- Trial name
- NCT07744568
- Testing
- ETHICON™ 4000 Stapler System, Standard of Care Stapler and Reloads
- Volunteers
- 300 people
- Sponsor
- Ethicon Endo-Surgery
Post-Dental Gingival Pain, Gingival Swelling
Efficacy and Safety of HA35 Gel for Post-Dental Gingival Pain and Swelling
This is a prospective, single-arm, open-label, pilot clinical study to evaluate the efficacy and safety of 10% high-concentration 35 kDa hyaluronan (HA35) gel delivered via gel-soaked cotton balls in patients with gingival pain…
- Conditions
- Post-Dental Gingival Pain, Gingival Swelling, Postoperative Oral Pain, Dental Procedure-Related Discomfort
- Trial name
- HA35 (NCT07584655)
- Testing
- 10% High-Concentration 35 kDa Hyaluronan (HA35) Oral Topical Gel
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Nakhia Impex LLC
Robotic Surgical Procedures in Pediatric Urology
Versius Paediatrics Study
This is prospective, multi-phase, single arm, multi-centre, multi-surgeon feasibility clinical trial to provide proof of concept and clinical evidence regarding the safety and efficacy of Versius (robotic surgery medical device)…
- Trial name
- NCT06539442
- Testing
- Versius Surgical System
- Where
- 3 sites in United Kingdom
- Volunteers
- 150 people
- Sponsor
- CMR Surgical Ltd
Atrial Fibrillation, Maze Procedure
CellFX® Nanosecond Pulsed Field Ablation (nsPFA)™ Cardiac Surgery Clamp System to Treat Atrial Fibrillation
The primary objective of this Pivotal study is to demonstrate the safety and effectiveness of the Pulse Biosciences nsPFA™ Cardiac Surgery System in treating atrial fibrillation during concomitant cardiac surgical procedures.
- Conditions
- Atrial Fibrillation, Maze Procedure, AF, Ablation
- Trial name
- NANOCLAMP-AF (NCT06959121)
- Testing
- CellFX® nsPFA™ Cardiac Surgery System
- Where
- 3 sites in United States
- Volunteers
- 135 people
- Sponsor
- Pulse Biosciences, Inc.
Aging, Mortality
Longevity Metrics AI/ML Development Study
This study builds AI models that score diagnostic screening tests, and that predict screening results, clinical judgment, and life expectancy.
- Conditions
- Aging, Mortality, Cardiovascular Disease Prevention, Metabolic Syndrome
- Trial name
- NCT07808619
- Testing
- AIML scored health screening battery
- Where
- United States
- Volunteers
- 1,000,000 people, healthy volunteers welcome
- Sponsor
- Longevity Metrics, Inc.
Diagnostic Techniques and Procedures, Clinical Laboratory Techniques
Clinical Validation of an Artificial Intelligence System for the Interpretation of Laboratory Test Results Combined With a Structured Medical History
This study evaluates a certified artificial intelligence (AI) based software system that automatically interprets laboratory test results in combination with a structured, dynamically generated medical history questionnaire.
- Conditions
- Diagnostic Techniques and Procedures, Clinical Laboratory Techniques, Triage
- Trial name
- LTC-VALID (NCT07810491)
- Testing
- AI-based laboratory result interpretation software
- Where
- 2 sites in Poland
- Volunteers
- 899 people
- Sponsor
- Labplus Sp. z o.o.
Kidney Transplant, Kidney Failure
Hypothermic Machine Perfusion With Omnisol of Deceased Donor Kidneys Prior to Transplantation
Insufficient availability of organs from brain dead (DBD) and living donors has necessitated increased use of less than optimal organs from donation after cardiac death (DCD) or from extended criteria donors.
- Conditions
- Kidney Transplant, Kidney Failure, Renal and Urinary Tract Therapeutic Procedures, End Stage Renal Disease (ESRD)
- Trial name
- NEWHOPE (NCT07792317)
- Testing
- Omnisol organ preservation solution
- Where
- Netherlands
- Volunteers
- 15 people
- Sponsor
- Vivalyx GmbH
Reconstructive Surgical Procedures
A Retrospective Assessment of OviTex PRS (OviTex)
The objective of this retrospective-prospective, observational study is to evaluate the safety profile overall and within two device types of OviTex PRS in previous pre-pectoral or sub-pectoral implant-based breast…
- Trial name
- PRS (NCT05736848)
- Testing
- OviTex® PRS
- Where
- 11 sites in United States
- Volunteers
- 200 people
- Sponsor
- Tela Bio Inc
Minimally Invasive Surgical Procedures, Laparoscopy
Post-market Clinical Follow-up Study of Reusable Clip Applier Cartridge Devices for LAParoscopic Surgery
This is a Post-Market Clinical Follow-up (PMCF) investigation to determine the long-term effectiveness and safety of the Multi-Fire Clip System in laparoscopic surgery.
- Conditions
- Minimally Invasive Surgical Procedures, Laparoscopy, Leakage of Cardiac Device
- Trial name
- RELAP (NCT05363813)
- Testing
- M/L-10 Multi-Fire Clip Applier and M/L-10 Clip Cartridge (Multi-Fire Clip System)
- Where
- 7 sites in Portugal, Spain
- Volunteers
- 245 people
- Sponsor
- Microline Surgical, Inc.