Clinical trials: Global Surgery
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
Anesthesia, General
Safety and Efficacy of Sugammadex (Org 25969, MK-8616) in Participants With or Having a Past History of Pulmonary Disease (19.4.308) (P05932) (MK-8616-017)
The purpose of the trial is to research the safety and to show faster recovery after administration of 2.0 mg/kg or 4.0 mg/kg sugammadex (Org 25969, MK-8616) given as a reversal agent for 0.6 mg/kg (0.15 mg/kg maintenance dose)…
- Trial name
- NCT00475215
- Testing
- Sugammadex, Rocuronium
- Volunteers
- 86 people
- Sponsor
- Merck Sharp & Dohme LLC
Anesthesia
Study of the Efficacy and Safety of Remimazolam in General Anesthesia in Adults Undergoing Cardiac Surgery
This study investigates the use of remimazolam as a sedative/hypnotic in general anesthesia. Remimazolam or propofol will be administered together with fentanyl/sufentanil/remifentanil as opioid analgesics and a neuromuscular…
- Trial name
- NCT02523859
- Testing
- Propofol, Remimazolam
- Where
- Germany
- Volunteers
- 25 people
- Sponsor
- Paion UK Ltd.
General Anesthesia, Blood Pressure
Assessment of Effectiveness of Continuous Non-invasive Haemodynamic Monitor by Compared to Invasive Blood Pressure and Pulse Oximeter Monitoring on Patients Undergoing General Anesthesia Surgeries for More Than 60 Minutes
The goal of this observational study is to assess whether the continuous non-invasive haemodynamic monitor MOH200 (measuring blood pressure as well as pulse rate) is effective or not in people undergoing general anesthetic…
- Conditions
- General Anesthesia, Blood Pressure, Pulse Rate, Arterial Line
- Trial name
- NCT06383000
- Volunteers
- 55 people
- Sponsor
- BLZ Technology (Wuhan) Co.,Ltd
Open Angle Glaucoma, Ocular Hypertension
MINIject Global Long-Term Follow-up Study
The study will assess the long-term (up to 5 years) safety and performance in patients with open-angle glaucoma uncontrolled by topical hypotensive medications who had previously been implanted with a MINIject glaucoma implant.
- Trial name
- STAR-GLOBAL (NCT04524416)
- Testing
- Minimally invasive glaucoma surgery (MIGS)
- Where
- 9 sites in Colombia, France and 4 more
- Volunteers
- 116 people
- Sponsor
- iSTAR Medical
NSCLC, Adjuvant Treatment
A Study to Assess the Efficacy and Safety of Firmonertinib Versus Placebo for Adjuvant Treatment in Participants With Stage IB - IIIB NSCLC With Uncommon Epidermal Growth Factor Receptor (EGFR) Mutations, Following Complete Surgical Resection With or Without Adjuvant Chemotherapy（FIRMOST）
This is a Phase 3, global, double-blind, randomized, controlled multicenter clinical study to assess the efficacy and safety of adjuvant treatment with firmonertinib versus placebo in participants with Stage IB-IIIB NSCLC with…
- Trial name
- FIRMOST (NCT07010419)
- Testing
- Firmonertinib
- Where
- 2 sites in China
- Volunteers
- 338 people
- Sponsor
- Allist Pharmaceuticals, Inc.
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.
Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer
Clinical Trial to Evaluate the Efficacy and Safety of a Thoracic and Abdominal Endoscopic Surgical System
Evaluation of the efficacy and safety of thoracic and abdominal endoscopic surgical systems manufactured by Shenzhen Cornerstone Robotics Technology Co., Ltd. for use in general, gynaecological and thoracic surgical procedures.
- Conditions
- Pathologic Stage I Gastric Cancer AJCC v8, Colorectal Cancer, Esophageal Cancer, Hepatectomy
- Trial name
- NCT06587152
- Testing
- Robot-assisted surgery
- Where
- China
- Volunteers
- 60 people
- Sponsor
- Cornerstone Robotics
Postoperative Pain
Maxigesic® IV Phase 3 Exposure Study
The study aims to determine the tolerability of repeated doses of Maxigesic® IV over an extended period of exposure.
- Trial name
- NCT04005755
- Testing
- Maxigesic® IV
- Where
- 4 sites in United States, New Zealand
- Volunteers
- 232 people
- Sponsor
- AFT Pharmaceuticals, Ltd.
Anesthesia, General
Evaluation of Volatile Induction and Maintenance Anesthesia (VIMA) With Sevorane in Adult Patients Required General Anesthesia for Surgery in Terms of Quality of Anesthesia and Its Influence on Cardiovascular System in Common Clinical Practice
The main objective of this post-marketing observational study is to collect data from the use of general anesthesia in patients undergoing any surgery to create local recommendations.
- Trial name
- SEVOPROTECTION (NCT01282203)
- Where
- 12 sites in Kazakhstan
- Volunteers
- 1,122 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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.
Anesthesia
A Study to Evaluate the Accuracy of aTCI Model of Cipepofol in Patients With General Anesthesia During Elective Surgery
This study is a multi-center (each center independently conducts the study according to the same research protocol), randomized, and open-label clinical study.
- Trial name
- NCT06740201
- Testing
- Cipepofol
- Where
- 2 sites in China
- Volunteers
- 40 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
Surgical Procedure, Unspecified
Comparison of Adequacy of Anesthesia Monitoring With Standard Clinical Practice During Routine General Anesthesia
The purpose of this study is to demonstrate that using Surgical Pleth Index (SPI) and Entropy in adjunct to other clinical information decreases the occurrence rate of inadequate anesthesia events, bradycardia and hypotension in…
- Trial name
- NCT01928875
- Testing
- AoA Monitoring, Routine (Standard) Anesthesia Monitoring
- Where
- 4 sites in Finland, Germany and 2 more
- Volunteers
- 496 people
- Sponsor
- GE Healthcare
Anesthesia, General, Fluid Therapy
Management of Intraoperative Fluids in Ambulatory Surgery
This is a single-center prospective randomized control trial (RCT) to determine whether the continuous monitoring of the plethysmographic variability index (PVI) during low-risk surgeries, can be used to optimize the…
- Conditions
- Anesthesia, General, Fluid Therapy, Ambulatory Surgical Procedures
- Trial name
- MIFAS (NCT03193320)
- Testing
- Fluid therapy protocol
- Where
- Venezuela
- Volunteers
- 243 people, healthy volunteers welcome
- Sponsor
- Policlinica Metropolitana
Anesthesia
Japan Phase 2/3 Clinical Study With BLM-240 (Desflurane)
The purposes of this study are to evaluate the efficacy and safety of desflurane (BLM-240) as an anesthetic agent and to demonstrate the non-inferiority of desflurane to sevoflurane in term of awakening/recovery from anesthesia.
- Trial name
- NCT00762372
- Testing
- desflurane, desflurane/nitrous oxide, sevoflurane/nitrous oxide
- Where
- 15 sites in Japan
- Volunteers
- 216 people
- Sponsor
- Baxter Healthcare Corporation
Induction of General Anaesthesia
A Phase IIa Study Investigating the Tolerance, Efficacy and Safety of HSK3486
This is a Phase IIa, open-label, propofol-controlled ,dose-escalation, multi-center Study to evaluate the tolerance, efficacy and safety of HSK3486 for induction of general anesthesia in elective surgery patients.This study is…
- Trial name
- NCT03698617
- Testing
- HSK3486, Propofol
- Where
- China
- Volunteers
- 114 people
- Sponsor
- Sichuan Haisco Pharmaceutical Group Co., Ltd
General Anesthesia, Elective Surgery
Therapeutic Equivalence (TE) Study of Propofol 2% MCT Fresenius (MCT=Medium-Chain Triglycerides) Compared With Diprivan® in Patients Undergoing Elective Surgery
The purpose of this study is to evaluate the therapeutic equivalence, based on pharmacodynamic parameters of Propofol 2% (20 mg/mL) MCT Fresenius and Diprivan® 20 mg/mL (AstraZeneca), administered by target controlled infusion…
- Trial name
- PropofolTE (NCT01856998)
- Testing
- Propofol, Diprivan
- Where
- France
- Volunteers
- 71 people
- Sponsor
- Fresenius Kabi
Post-Operative Nausea and Vomiting
A Study of Kytril (Granisetron) in the Prevention of Post-Operative Nausea and Vomiting (PONV) in Pediatric Subjects Undergoing Tonsillectomy or Adenotonsillectomy
This 2 arm study will evaluate the efficacy and safety of a single intravenous injection of Kytril in preventing postoperative nausea and vomiting (PONV) in children.
- Trial name
- NCT00231478
- Testing
- granisetron
- Where
- 11 sites in United States
- Volunteers
- 171 people
- Sponsor
- Hoffmann-La Roche
Healthy
The Efficacy and Safety of Gantacurium Chloride for Injection in Tracheal Intubation in Healthy Adult Patients Undergoing Surgery Under General Anesthesia
This is a multicenter, randomized, controlled, observer-blinded, dose-response study to evaluate the efficacy in tracheal intubation and safety of gantacurium chloride for injection in healthy adult patients undergoing surgery…
- Trial name
- NCT00235976
- Testing
- Gantacurium Chloride for Injection (AV430A)
- Where
- Germany
- Volunteers
- 200 people
- Sponsor
- Avera Pharmaceuticals
General Laparoscopic Surgeries
Comparison of Laparoscopic Procedures With and Without the Aid of the AutoLap System- a Robotic Camera Holder
The objective of this study is to evaluate the ability to reduce the number of OR personnel required while performing the following procedures: colon resections, cholecystectomies and anti-reflux/hiatal hernia surgery with the…
- Trial name
- NCT02934542
- Testing
- AutoLap system
- Where
- Netherlands
- Volunteers
- 108 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.