Clinical trials: Surgical Performance
Oral Hemorrhage
Performance and Safety of the Surgical Hemostatic Agent "HEMOCOLLAGENE®" in Patients Requiring Oral Surgery
The aim of this study is to collect performance and safety data relating to the use and the follow-up of the HEMOCOLLAGENE® medical device in routine clinical practice from various hospitals and medical centers in oral dental…
- Trial name
- NCT05171231
- Testing
- HEMOCOLLAGENE® : Sterile absorbable hemostatic sponges based on bovine collagen - class III MD
- Where
- 10 sites in Belgium, France
- Volunteers
- 125 people
- Sponsor
- Septodont
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
Congenital Heart Disease, Cardiopulmonary Bypass
Influence of Personalized Lung Volume Optimization Maneuver on Lung Function and Cardiac Performance in Children
The goal of this randomized interventional clinical trial is to learn if a standardized lung volume optimization maneuver (LVOM) is beneficial in 1.
- Conditions
- Congenital Heart Disease, Cardiopulmonary Bypass, Cardiac Surgery, Mechanical Ventilation
- Trial name
- ILOCO (NCT07193719)
- Testing
- End-expiratory lung volume optimization maneuver with PEEP titration, Standard Care (in control arm)
- Where
- Germany
- Volunteers
- 80 people
- Sponsor
- Charite University, Berlin, Germany
Scoliosis
Study of the Surgical Treatment of Early Onset Scoliosis Using a Non-invasive Growing Rod
It is current practice for children who have surgery for early onset scoliosis (EOS) to be treated with insertion of extendable implants known as growth rod systems.
- Trial name
- NCT01362881
- Where
- 2 sites in United Kingdom
- Volunteers
- 14 people
- Sponsor
- Ellipse Technologies, Inc.
Orthognathic Surgery, Maxillofacial Abnormalities
Study Evaluating the Performance and Safety of Global D Implants Indicated for Orthognathic Surgery
This study is set up within the framework of the European Union regulation 2017/745 on medical devices. Its objective is to confirm the performance and safety of the Global D implants (ORTRAUTEK® and MINITEK®) used for…
- Conditions
- Orthognathic Surgery, Maxillofacial Abnormalities, Maxilla Fracture
- Trial name
- CMF-ORTHO (NCT05271383)
- Testing
- Orthognathic surgery using Global D's implants.
- Where
- France
- Volunteers
- 198 people
- Sponsor
- Global D
Charcot Marie Tooth Disease (CMT), Pes Cavovarus
Walking Function Outcomes Following Surgical Correction With Rehabilitation Versus Physical Therapy Alone in Charcot-Marie-Tooth Disease: A Bidirectional Cohort Study
The goal of this study is to compare changes in walking ability in people with Charcot-Marie-Tooth disease (CMT) who receive two different treatment approaches for foot deformities that affect walking.
- Conditions
- Charcot Marie Tooth Disease (CMT), Pes Cavovarus, Surgery, Exercise Training
- Trial name
- CMT-WALK (NCT07432035)
- Testing
- Functional Surgery plus Rehabilitation, Physical Exercise
- Volunteers
- 200 people
- Sponsor
- Peking University Third Hospital
Gastric Cancer
Learning Curve and Optimization of Robotic Gastrectomy
we explore the learning curve and the impact of technique optimization on surgical outcomes and the first to construct a referenceable learning phase for performing robotic gastric cancer surgery.
- Trial name
- NCT05715775
- Where
- China
- Volunteers
- 527 people
- Sponsor
- Fujian Medical University
Gynecological Surgeries
A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries(SPiM-RWS-GYN)
Study name：A Real-World Study to Evaluate the Clinical Performance and Safety of da Vinci SP Surgical System for Single-Port Gynecological Surgeries Study purpose：This clinical trial is a real-world study to evaluate the clinical…
- Trial name
- NCT06082011
- Testing
- da Vinci SP Surgical System
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Ruijin Hospital
Aortic Valve Stenosis
Post-Market Surveillance Registry to Monitor Performance and Safety of V8 Device
This registry is designed to monitor the real world clinical performance and safety of the V8 device used to perform balloon aortic valvuloplasty (BAV).
- Trial name
- TAB-R (NCT02099942)
- Testing
- V8 Balloon Aortic Valvuloplasty (BAV) Catheter
- Where
- 7 sites in United States
- Volunteers
- 103 people
- Sponsor
- InterValve, Inc.
Cardiac Surgery, Thoracic Surgery
Heart Lung Machine Registry
The HeaLMe post-market clinical follow-up registry is undertaken to evaluate the safety and performance of the index devices Heart Lung Machine HL 40 and Temperature Probes TPO-D-HLM L1.8 Adult / Pediatric in patients undergoing…
- Conditions
- Cardiac Surgery, Thoracic Surgery, Vascular Surgery, Cardiopulmonary Bypass
- Trial name
- HeaLMe (NCT06159517)
- Where
- 3 sites in Italy, Spain
- Volunteers
- 184 people
- Sponsor
- Maquet Cardiopulmonary GmbH
Simulator-based Medical Skill Training
Video Game Experience and Warm-Up Effects on Laparoscopic Skills Among Medical Students
"In surgical practice, alternative training methods are being investigated to enhance laparoscopic skills. The potential correlation between video game playing and technical performance improvements raises the question of whether…
- Trial name
- V-LAP (NCT07837388)
- Testing
- Surgical Simulator, 10 minute exercice of videogame
- Where
- Brazil
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Universidade de Passo Fundo
Burn Injury, Skin Graft
A Soft Silicone Wound Contact Layer Containing Silver in the Treatment of Skin Grafts in Surgical Burn Patients.
Part A The primary objective of Part A will be to verify performance and safety of Mepitel® Ag, a meshed, non- adherent soft silicone wound contact layer containing silver in the treatment of skin grafts in surgical burn…
- Trial name
- MpTAg03 (NCT02210208)
- Testing
- Mepitel® Ag, Mepilex® Transfer Ag
- Where
- 4 sites in United States
- Volunteers
- 25 people
- Sponsor
- Molnlycke Health Care AB
Anesthesia, Child
Performance Evaluation of the Depth of Anesthesia Monitors in Pediatric Surgery
The purpose of this study is to determine how Bispectral index (BIS) and Entropy EEG monitors agree between themselves and with end-tidal concentration of sevoflurane (ETsevo) in relationship with the age in the pediatric surgery…
- Trial name
- NCT02240368
- Where
- Italy
- Volunteers
- 50 people
- Sponsor
- University of Foggia
Contusions, Incision
Dermal Wound Closure Using Silkam®
Assessment of performance of Silkam® suture material for skin closure. A prospective, single center, single arm, observational study in daily practice.
- Conditions
- Contusions, Incision, Laceration
- Trial name
- DERMASILK (NCT05225714)
- Where
- Spain
- Volunteers
- 161 people
- Sponsor
- Aesculap AG
da Vinci SP Surgical System, Thoracic Surgery
Valuate the Clinical Performance and Safety of da Vinci SP Surgical System
This clinical trial is a real-world study to evaluate the clinical performance and safety of da Vinci SP Surgical System ("SP single-port robot" for short) for single-port robot-assisted thoracic surgeries in the real world…
- Trial name
- NCT06246617
- Testing
- da Vinci SP Surgical System for Single-Port Thoracic Surgeries
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Ruijin Hospital
Abdominal Vascular Surgery, Peripheral Vascular Surgery
A Retrospective, Observational, Multicenter, Study to Collect Clinical Safety and Performance Data on POLYMAILLE®C
Purpose of the study is to describe safety and performance of POLYMAILLE® C from a minimum of 200 subjects will be evaluated. A minimum of 100 subjects will be evaluated for each main location of surgery (abdominal and…
- Conditions
- Abdominal Vascular Surgery, Peripheral Vascular Surgery, Vascular Prothesis, Aneurysm Abdominal
- Trial name
- NCT05517876
- Testing
- Vascular abdominal or peripheral surgery
- Where
- France
- Volunteers
- 212 people
- Sponsor
- Perouse Medical
Osteoarthritis, Osteoarthritis, Knee
The Effectiveness of Resistance Training for Patients With Degenerative Arthritis After Surgery
Osteoarthritis is a common degenerative disease that significantly impacts mobility and disability in older adults. This pilot randomized controlled study aimed to examine the effects of a three-month resistance training program…
- Trial name
- Arthritis (NCT07696195)
- Testing
- Progressive Lower Extremity Resistance Exercise, Routine Postoperative Rehabilitation Care
- Where
- Taiwan
- Volunteers
- 24 people
- Sponsor
- Tzu Chi University
Healthy, Adult ALL
Motion Capture as a Tool for the Assessment of Laparoscopic Performance
The goal of this study is to 1) identify motion capture variables that can be used to differentiate surgical experience level and 2) evaluate if these variables can be used in a surgical education setting to improve resident…
- Trial name
- NCT04646304
- Testing
- Objective Feedback (Motion Capture)
- Where
- Canada
- Volunteers
- 26 people, healthy volunteers welcome
- Sponsor
- Ottawa Hospital Research Institute
Hemorrhage, Surgical
Clinical Safety and Performance of GATT-Patch in Open Liver Surgery
The purpose of this study is to determine the clinical safety and performance of GATT-Patch for management of haemorrhage during elective open liver surgery.
- Trial name
- NCT04819945
- Testing
- GATT-Patch
- Where
- 3 sites in Netherlands
- Volunteers
- 56 people
- Sponsor
- GATT Technologies BV
Healthy Volunteers
Impact of Different Face Masks on Maximal and Submaximal Performance Testing During COVID-19
In COVID 19, masks wearability has become a new normal and this "new normal" presented evidence-based performance limitations. The study findings are aimed to objectify parametric changes (if any) and therefore, will assist in…
- Trial name
- NCT05150613
- Testing
- No Mask, Surgical Mask, N95 Mask
- Where
- 2 sites in Pakistan
- Volunteers
- 62 people, healthy volunteers welcome
- Sponsor
- Riphah International University