Clinical trials: Surgical Performance
Surgery
Evaluation of Coaching Impact on Surgical Outcomes
This two arms parallel cluster-randomized trial will evaluate the impact of a customized coaching program for surgeons on the occurrence of patient major adverse events.
- Trial name
- TopSurgeons (NCT04532658)
- Testing
- Coaching program
- Where
- France
- Volunteers
- 20,791 people
- Sponsor
- Hospices Civils de Lyon
General Laparoscopic Surgery Candidate, Bariatric Laparoscopic Surgery Candidate
Usability and Performance Evaluation of the AutoLap System - a Feasibility Study
The main objectives of this study are to evaluate the ease of use and performance of the AutoLap system compared to human camera holder during general and bariatric laparoscopic surgeries.
- Trial name
- NCT02346552
- Testing
- AutoLap
- Where
- United States
- Volunteers
- 46 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
Reconstructive Surgical Procedures, Plastic Surgery
Leica Microsystems Sponsored Study to Collect and Confirm Clinical Data on the Performance of the GLOW800 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 GLOW800 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Reconstructive Surgical Procedures, Plastic Surgery, Vascular Surgical Procedure, Cerebrovascular Disorder
- Trial name
- IMED-GLOW800 (NCT07164040)
- Testing
- The GLOW800, a non-contact, non-invasive device, allows the surgical microscope ARveo 8 and ARveo 8X to produce excitation light and resolve fluorescence emission from the fluorescent agent ICG
- Where
- 3 sites in Portugal, Spain and 1 more
- Volunteers
- 31 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Vascular Aneurysm, Vascular Occlusive Disease
LeMaitre® CARDIAL Dialine II Post Market Study
This clinical study will capture clinical data specific to the performance and safety of the LeMaitre® CARDIAL Dialine II. It is a retrospective, monocenter, post-market safety and performance study.
- Conditions
- Vascular Aneurysm, Vascular Occlusive Disease, Artery Injury
- Trial name
- Dialine II® (NCT05350358)
- Testing
- LeMaitre Cardial Dialine II
- Where
- France
- Volunteers
- 262 people
- Sponsor
- Geprovas
Cataract, Vitrectomy
Clinical Study to Confirm the Safety and Performance of the Virtuoso Phaco-vitrectomy Device
This is a pre-market clinical investigation with a device that does not bear the CE-marking. Aim of the study is to confirm the safety and performance of the device and collect user feedback.
- Conditions
- Cataract, Vitrectomy, Vitrectomy Operation Under General Anesthesia
- Trial name
- Virtuoso1 (NCT06799156)
- Where
- Germany
- Volunteers
- 205 people
- Sponsor
- Beaver-Visitec International, Inc.
Medical Education, User-Computer Interface
The Effect of Virtual Simulation Training in Mastoidectomy
The purpose of this study is to investigate the effect of virtual simulation training on mastoidectomy dissection performance of otorhinolaryngology trainees, to explore performance assessment using a final-product analysis…
- Conditions
- Medical Education, User-Computer Interface, Clinical Skills, Motor Skills
- Trial name
- NCT02030873
- Testing
- Virtual simulation training
- Where
- Denmark
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Copenhagen University Hospital, Rigshospitalet
Single Ventricle Heart Disease After Fontan Surgery
Pharmacokinetic/Pharmacodynamic Study of Udenafil in Adolescents
To determine the pharmacokinetic profile and safety of udenafil in adolescents with Fontan physiology and to assess the short-term pharmacodynamic effect of udenafil on pharmacodynamic measures of exercise capacity, ventricular…
- Trial name
- NCT02201342
- Testing
- Udenafil
- Where
- 6 sites in United States, Canada
- Volunteers
- 36 people
- Sponsor
- Mezzion Pharma Co. Ltd
Cataract, Cataract Surgery
Binocular and Monocular Distance-Corrected Visual Performance and Defocus Characteristics of Clareon Truplus Intraocular Lens (IOL)
This study aims to generate data that characterizes visual outcomes, including the binocular distance-corrected intermediate visual acuity (DCIVA) at 66cm or defocus behavior, of the Clareon TruPlus modified monofocal intraocular…
- Conditions
- Cataract, Cataract Surgery, Cataract Bilateral, Cataract (Post-operative Cataract Surgery Follow-up)
- Trial name
- BMVDI (NCT07589894)
- Testing
- Clareon TruPlus IOL
- Where
- United States
- Volunteers
- 50 people
- Sponsor
- Colvard Kandavel Eye Center
Congenital Heart Disease, Cardiac Surgery
Exercise Prehabilitation in Congenital Heart Disease
Around 8-12 in every 1000 babies are born with an abnormal heart, known as a congenital heart defect (CHD). Thanks to major advances in medical and surgical care, most babies born with CHD now live into adulthood.
- Trial name
- ACE-CHD (NCT07700459)
- Testing
- Exercise prehabilitation
- Where
- United Kingdom
- Volunteers
- 32 people
- Sponsor
- Liverpool Heart and Chest Hospital NHS Foundation Trust
Hip-surgery, Knee-surgery
Prospective, Randomized Study of 2 Different Wound Dressings
The primary objective of this investigation is to evaluate the performance of a self-adhesive absorbent post-operative dressing coated with a soft silicone layer in minimize the risk of the development of blistering in subjects…
- Conditions
- Hip-surgery, Knee-surgery, Spinal-surgery
- Trial name
- Close (NCT01988818)
- Testing
- Mepilex® Border Post-Op, standard wound dressing
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- University of Cologne
Intracranial Embolism and Thrombosis, Postoperative Complications
TCD Detection of Gas and Solid Micro-Emboli in Patients Undergoing Coronary Artery Bypass Grafting (CABG): The Influence of Proximal Anastomosis Technique
The purpose of this study is to test the hypothesis that using three different techniques to anastomose coronary grafts to the aorta: partial occlusion, single cross clamp, or using the Heartstring anastomotic device, will change…
- Trial name
- NCT00294814
- Testing
- Proximal anastomosis using Heartstring anastomotic device
- Where
- Israel
- Volunteers
- 100 people
- Sponsor
- Rambam Health Care Campus
Peripheral Arterial Disease, Peripheral Artery Disease
FRAME, External Support for Lower Limb Autologous Grafts
30 patients will be enrolled in a prospective, multi-center, one-arm study, enrolling patients with claudication and chronic limb ischemia scheduled for lower limb venous bypass grafting on clinical grounds with single segment…
- Trial name
- NCT04003480
- Testing
- FRAME
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- Vascular Graft Solutions Ltd.
Head and Neck Cancers
Evaluation Clinique Des Performances Du Dispositif D'Aide À La Chirurgie Dyameo
During the surgical removal of head and neck tumours, the correct determination of the boundary between healthy and tumour tissue is critical.
- Trial name
- ETCETERA (NCT06618170)
- Testing
- Tissue surface analysis with the device
- Volunteers
- 80 people
- Sponsor
- Dyameo
Cataract, Presbyopia
The Visual Performances of a Progressive Multifocal Intraocular Lens With Extended Depth of Focus
The purpose of this observational, non-controlled, multicenter trial with a retrospective design is to evaluate the visual performance of one cohort of patients who received the EDOF MINI WELL® intraocular lenses following…
- Trial name
- NCT02740010
- Testing
- EDOF Mini WELL Ready IOL
- Where
- Italy
- Volunteers
- 100 people
- Sponsor
- SIFI SpA
ACL Rupture
Clinical Performance and Safety of ENDOPACK® DT4-EBMCA in ACL Reconstruction 24 Months Post-surgery
Anterior cruciate ligament (ACL) injuries are among the most common sports-related knee traumas. The DT4-EBMCA device, based on a quadrupled semitendinosus autograft technique, aims to provide effective and minimally invasive…
- Trial name
- DT4-EBMCA (NCT06990100)
- Testing
- ACL surgery
- Where
- France
- Volunteers
- 36 people
- Sponsor
- SACIMEX
Soft Tissue Surgeries
A Study on the Safety and Effectiveness of the Mantra™ Surgical Robotic System for Soft Tissue Surgeries
A Real-World, multicentre retrospective study to evaluate the clinical performance and safety of MantraTM Surgical Robotic System for soft tissue surgeries.
- Trial name
- MARS (NCT06974955)
- Where
- India
- Volunteers
- 365 people
- Sponsor
- Sudhir Srivastava Innovations Pvt. Ltd.
Cataract, Presbyopia
Non-comparative Study to Assess the Visual Performances and Safety of a Progressive Multifocal Intraocular Lens
This is an interventional, non-controlled, multicenter international trial with a prospective design on one cohort of patients.
- Trial name
- PSM15 (NCT02838004)
- Testing
- IOL MINI WELL READY
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- SIFI SpA
Inguinal Hernia
Safety and Performance Study of TIGR Matrix Surgical Mesh in Inguinal Hernia Repair
This an open, uncontrolled multicenter clinical study to assess the safety and performance of the WK-6 surgical mesh in adult patients with unilateral inguinal hernia.
- Trial name
- NCT01193985
- Testing
- TIGR Matrix Surgical Mesh
- Where
- 2 sites in Sweden
- Volunteers
- 40 people
- Sponsor
- Novus Scientific
Cataract Surgery, Single-piece IOL, Microincisional IOL
Capsule Bag Performance of a Novel Single-piece Acrylic IOL HOYA AF-1 NY-60
During the past decades, cataract surgery underwent tremendous change and modernisation resulting in today's small incision, phacoemulsification surgery and a safe technique with a short rehabilitation time for the patient.
- Trial name
- NCT07167589
- Testing
- Cataract surgery with implantation of a single-piece microincisional IOL
- Where
- Austria
- Volunteers
- 42 people
- Sponsor
- Vienna Institute for Research in Ocular Surgery
Brain and Central Nervous System Tumors
Radiation Therapy in Treating Patients With Progressive or Recurrent Malignant Brain Tumors
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Giving radiation therapy in different ways may kill more tumor cells.
- Trial name
- NCT00003574
- Testing
- surgical procedure, brachytherapy, intraoperative radiation therapy
- Where
- 9 sites in United States
- Sponsor
- New Approaches to Brain Tumor Therapy Consortium