Clinical trials: Surgery, Laparoscopic
Bariatric Surgery Candidate, Cholelithiases
Safety and Feasibility of the Use of the Dual Robotic Arm Accessory With the Levita Magnetic Surgical System in Laparoscopic Procedures
The purpose of this study is to evaluate the safety and feasibility of the Levita Dual Robotic Arm Accessory (DRAA) used with the Levita Magnetic Surgical System (MSS)
- Conditions
- Bariatric Surgery Candidate, Cholelithiases, Other Disease
- Trial name
- MARS GI (NCT05695989)
- Testing
- Dual Robotic Arm Accessory (DRAA)
- Where
- 3 sites in Chile
- Volunteers
- 22 people
- Sponsor
- Levita Magnetics
Neuromuscular Blockade
Rocuronium + Sugammadex vs. Succinylcholine + Cisatracurium + Neostigmine/Atropine in Obese Participants (MK-8616-104)
The primary objective of this trial is to compare the preference between two strategies of neuromuscular blocking (NMB) / reversal in adult obese patients undergoing laparoscopic abdominal surgery: Rocuronium + Sugammadex versus…
- Trial name
- BENN (NCT02410590)
- Testing
- Rocuronium, Sugammadex, Cisatracurium
- Sponsor
- Merck Sharp & Dohme LLC
Laparoscopic Roux-en-y Gastric Bypass
The BlackBox Study
This is a hypothesis generating pilot study to compare the impact of 2D versus 3D visualization on surgical performance, as measured by the OR BlackBox platform, during laparoscopic bariatric surgery.
- Trial name
- NCT03252470
- Testing
- Laparoscopic Roux-en-y Gastric Bypass Surgery
- Where
- Canada
- Volunteers
- 50 people
- Sponsor
- Olympus Corporation of the Americas
Obesity, Morbid Obesity
Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery
We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure…
- Trial name
- NCT01041261
- Testing
- BariatrX Essentials 360 Treatment
- Where
- United States
- Volunteers
- 7 people
- Sponsor
- MetaProteomics LLC
Gastroesophageal Reflux
Esomeprazole (NEXIUM) vs. Surgery
The study investigates the efficacy of long-term treatment of esomeprazole compared to anti-reflux surgery in the control of gastroesophageal reflux disease by assessing time to treatment failure.
- Trial name
- LOTUS (NCT00251927)
- Testing
- esomeprazole, Laparoscopic fundoplication (surgery)
- Where
- 59 sites in Austria, Belgium and 10 more
- Volunteers
- 626 people
- Sponsor
- AstraZeneca
Pelvic Organ Prolapse (POP), Genital Prolapse
Safety and Performance of a Pelvic Floor Mesh Implant (LatGYNious)
The purpose of the clinical investigation is to verify that the investigational device (LatGYNious) is appropriate to significantly improve the pelvic organ prolapse in patients.
- Conditions
- Pelvic Organ Prolapse (POP), Genital Prolapse, Uterus Prolapse, Laparoscopic Surgery
- Trial name
- NCT07066761
- Testing
- Laparoscopic lateral suspension with surgical mesh (LatGYNious)
- Where
- 5 sites in Austria, Germany
- Volunteers
- 85 people
- Sponsor
- A.M.I. Agency for Medical Innovations GmbH
Uterine Fibroid
Safety and Efficacy of Actamax™Adhesion Barrier in Women Undergoing Laparoscopic Abdominopelvic Surgery/Myomectomy
Women undergoing laparoscopic abdominopelvic surgery with a planned, second look laparoscopy within 8-12 (+4) weeks will be enrolled. All subjects must undergo myomectomy with/without treatment of co-existing pathology e.g.
- Trial name
- NCT03450421
- Testing
- Actamax™Adhesion Barrier
- Volunteers
- 152 people
- Sponsor
- Actamax Surgical Materials LLC
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.
Acute Pain
A Single-arm Study Evaluating the Effectiveness and Safety of Suzetrigine (SUZ) for Acute Pain After Selected Surgeries
The purpose of this study is to evaluate the effectiveness, safety, and tolerability of SUZ for acute pain after laparoscopic procedures of the intraperitoneal or retroperitoneal cavities or arthroscopic orthopedic procedures.
- Trial name
- NCT06887959
- Testing
- Suzetrigine
- Where
- 17 sites in United States
- Volunteers
- 47 people
- Sponsor
- Vertex Pharmaceuticals Incorporated
Patients Who Were Scheduled for General and Gynecological Laparoscopic Procedures
Evaluation of the Follow Me Mode of the AutoLap System - A Feasibility Study
The main objectives of this study are to evaluate the performance and ease of use of the Follow me mode of the AutoLap system during general and gynecological laparoscopic procedures.
- Trial name
- NCT02326870
- Testing
- AutoLap
- Where
- 4 sites in Israel, Netherlands
- Volunteers
- 33 people
- Sponsor
- M.S.T. Medical Surgery Technology LTD.
Inguinal and Ventral Hernia Repair by Sublay, Underlay and IPOM Mesh Fixation
Effectiveness, Appropriateness and Safety of GLUTACK-Glubran Tiss 2 Surgical Glue Compared to GLUTACK-Glubran 2 Device System for Mesh Fastening in Laparoscopic and Robotic Hernia Surgery
This pre-market, prospective, randomized, non-inferiority clinical study was designed to evaluate the safety and performance/effectiveness of Glutack-Glubran® Tiss 2 system compared to Glutack-Glubran® used for mesh fixation in…
- Trial name
- AGluTHeMFix (NCT06462066)
- Testing
- Experimental medical device, Comparator medical device
- Where
- Italy
- Volunteers
- 101 people
- Sponsor
- GEM SRL
Tissue Adhesions
A Randomized Multi-centre Study to Assess the Safety and Manageability of a Laparoscopic Adhesion Barrier in Women Undergoing Gynecologic Laparoscopic Surgery Followed by Second Look Laparoscopy
The purpose of this study is to obtain data on the safety and manageability of applying LABS™ to the uterus and other areas of surgical trauma in the pelvis and abdomen following laparoscopic gynaecologic surgery.
- Trial name
- LABS-1 (NCT02260115)
- Testing
- LABS™, Surgical Control
- Where
- 4 sites in Germany, Greece
- Volunteers
- 78 people, healthy volunteers welcome
- Sponsor
- Actamax Surgical Materials LLC
Gall Bladder Disease, Bile Duct Diseases
AE05ML Device for ML Hem-o-lok Polymer Clip Delivery in Laparoscopic Surgical Procedures Observational Registery Study
This clinical registry study aims to evaluate the safety and effectiveness of the AE05ML device for ligating vessels and tissue structures during laparoscopic surgery using Hem-o-lok® Medium Large (ML) polymer clips.
- Conditions
- Gall Bladder Disease, Bile Duct Diseases, Acute Cholecystitis, Kidney
- Trial name
- AE05ML (NCT06364865)
- Testing
- laparoscopic procedure
- Where
- 3 sites in United States
- Volunteers
- 161 people
- Sponsor
- Teleflex
Myomas, Ovary Cysts
The Efficacy and Safety Study of a New Cross-linked Hyaluronan Hydrogel in the Reduction of Postsurgical Peritoneal Adhesions
The purpose of this study was to determine whether the new crosslinked hyaluronan hydrogel was safe to use, and was effective for the prevention/reduction of adhesion formation following gynecological surgery
- Conditions
- Myomas, Ovary Cysts, Endometriotic Cysts, Adhesions
- Trial name
- BAP (NCT02166554)
- Testing
- Saline, Cross-linked Hyaluronan Hydrogel
- Where
- 7 sites in China
- Volunteers
- 216 people
- Sponsor
- BioRegen Biomedical (Changzhou) Co., Ltd
Gallbladder Disease
SILS™ Port Laparoscopic Cholecystectomy Post Market Study
The objectives of this trial are: 1. to assess the feasibility and safety of performing SILS™ Port Laparoscopic Cholecystectomy 2.
- Trial name
- NCT00832767
- Testing
- SILS™ port laparoscopic cholecystectomy, Four Port Laparoscopic Cholecystectomy
- Where
- 10 sites in United States, Italy and 1 more
- Volunteers
- 202 people
- Sponsor
- Medtronic - MITG
Surgery
Maestro 1.1 Post-Market Registry
The objective of the study is to observe the real-life usage of the Maestro Platform for surgical assistance in laparoscopic surgery.
- Trial name
- NCT06103136
- Testing
- Laparoscopic surgery using the Maestro Platform
- Where
- 12 sites in United States, Belgium and 1 more
- Volunteers
- 600 people
- Sponsor
- Moon Surgical
Postoperative Nausea and Vomiting, Nausea and Vomiting, Postoperative
Post-Operative Nausea And Vomiting Study In Female Patients
The primary purpose of this study is to determine an effective dose of this NK-1 anti-emetic medication to prevent nausea and vomiting in females after surgery.
- Trial name
- NCT00274690
- Testing
- GW679769
- Where
- 44 sites in United States, Denmark and 9 more
- Volunteers
- 435 people
- Sponsor
- GlaxoSmithKline
Cholecystitis
SPY Fluorescence Imaging Systems and Indocyanine Green to Determine the Percentage of Successful Critical Anatomy Recognition in Laparoscopic Cholecystectomy Surgeries.
This is a prospective single arm, single center study estimating percentage of successful critical anatomy recognition in laparoscopic cholecystectomy surgeries using SPY fluorescence imaging and ICG, with each surgery also…
- Trial name
- NCT05006950
- Testing
- Stryker1688 Fluorescence imaging system
- Where
- United States
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Stryker Endoscopy
Postoperative Pain
Study to Evaluate Analgesic Effect of IV Administration of Kappa Agonist CR845 For Hysterectomy Surgery
The primary purpose of this study is to determine if CR845 is effective in treating the pain associated with a laparoscopic hysterectomy.
- Trial name
- NCT01361568
- Testing
- CR845
- Where
- 18 sites in United States
- Volunteers
- 203 people
- Sponsor
- Cara Therapeutics, Inc.
Appendicitis, Cholecystitis
NOVOsyn® for Trocar Incision After Laparoscopic Appendectomy and Cholecystectomy
The aim of this study is to evaluate if the application of a Chlorhexidine coated suture (Novosyn® CHD) will reduce the colonization of bacteria in comparison to an uncoated suture (Novosyn®) used for the closure of trocar wounds…
- Trial name
- NOVOTILAC (NCT04033211)
- Testing
- Novosyn® CHD for fascia and skin closure, Novosyn® for fascia and skin closure
- Where
- 4 sites in Germany, Spain
- Volunteers
- 316 people
- Sponsor
- Aesculap AG