Clinical trials: Procedure
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.
Valve-in-valve Procedures, Aortic Stenosis
The ShortCut™ Continued Access Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Continued Access Study of the ShortCut™ device (The ShortCut™ CAS).
- Conditions
- Valve-in-valve Procedures, Aortic Stenosis, Coronary; Obstruction
- Trial name
- ShortCut-CAS (NCT06211296)
- Testing
- Shortcut
- Where
- 4 sites in United States
- Volunteers
- 8 people
- Sponsor
- Pi-cardia
Minimally Invasive Surgical Procedures, Surgical Procedures, Operative
Medtronic Signia SDR Product Surveillance Registry
The purpose of the registry is to confirm the safety and performance of the Signia™ Small Diameter Reload (SDR) when used in surgical procedures in a real-world setting in patients receiving surgery for indicated thoracic…
- Trial name
- NCT05095935
- Testing
- N/A observational registry
- Where
- 14 sites in United States
- Volunteers
- 430 people
- Sponsor
- Medtronic
Bone Marrow Biopsy Procedures
Powered Bone Marrow Aspiration and Core Biopsy System Compared to Manual Devices
This is a randomized study evaluating use of a powered bone marrow biopsy and aspiration system (OnControl by Vidacare) compared to traditional manual devices.
- Trial name
- NCT01312519
- Testing
- OnControl Bone Marrow Biopsy and Aspiration System, Manual bone marrow sampling device
- Where
- 2 sites in United States, Spain
- Volunteers
- 50 people
- Sponsor
- Vidacare Corporation
Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures
A Prospective, Single-Arm Multi-Center Study of the HARMONIC® 1100 Shears in Select Devices
This prospective, single-arm, multi-center study will collect clinical data in a post-market setting for the pediatric population (general surgical procedures) and adult population (general, gynecological, urological, and…
- Conditions
- Pediatric Procedures, Adult Hepato-pancreato-biliary (HPB) Procedures, Adult Lower Gastrointestinal Procedures, Adult Gastric Procedures
- Trial name
- NCT05039021
- Testing
- HARMONIC 1100 Shears
- Where
- 7 sites in United States, Canada and 1 more
- Volunteers
- 265 people
- Sponsor
- Ethicon Endo-Surgery
Risk of Coronary Obstruction Following Transcatheter Aortic Valve Replacement (TAVR) Procedure
The ShortCut™ Study Protocol
A Prospective, Multicenter, Non-Randomized, Single-Arm, Open-Label Clinical Study to Demonstrate the Safety and Effectiveness of the ShortCut™ device for splitting bioprosthetic aortic valve leaflets in patients who are presented…
- Trial name
- NCT04952909
- Testing
- ShortCut™
- Where
- 23 sites in United States, France and 3 more
- Volunteers
- 60 people
- Sponsor
- Pi-cardia
Colorectal Procedures
Study of Colorectal Procedures With the Levita Magnetic Surgical System
The purpose of this study is to evaluate the safety and effectiveness of the Levita Magnetic Surgical System in patients undergoing colorectal procedures.
- Trial name
- NCT03960684
- Testing
- Levita Magnetic Surgical System
- Where
- Chile
- Volunteers
- 31 people
- Sponsor
- Levita Magnetics
Surgical Skin Preparation, Surgical Procedure, Unspecified
In Vivo Preoperative Skin Preparation Efficacy Study Within a Defined Product Coverage Area
This study evaluates reduction of resident flora produced by the test product within a defined prepped area of skin.
- Trial name
- NCT03681990
- Testing
- 3M CHG/IPA Prep
- Where
- Romania
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- Solventum US LLC
Central Nervous System Infections, Pseudotumor Cerebri
A Study to Test Performance of Needle Placements for Neuraxial Procedures Using Tactile Imaging vs Control
This study will compare the VerTouch device to the conventional palpation technique for performing diagnostic and therapeutic neuraxial procedures.
- Conditions
- Central Nervous System Infections, Pseudotumor Cerebri, Neurological Disorder, Cancer
- Trial name
- NCT04796935
- Testing
- Tactile Imaging (VerTouch), Control (palpation)
- Where
- 3 sites in United States
- Volunteers
- 95 people
- Sponsor
- IntuiTap Medical, Inc
Thoracic Procedure, Urologic Procedure
A Study of the ENSEAL® X1 Curved Jaw Tissue Sealer and Generator G11 in Thoracic, Urologic, and Ear, Nose, and Throat (ENT) Procedures
The purpose of this study is to demonstrate the acceptable performance and safety of the ENSEAL X1 curved jaw tissue sealer and Ethicon endo-surgery generator G11 (GEN11) devices when used per the instructions for use (IFU).
- Conditions
- Thoracic Procedure, Urologic Procedure, Ear, Nose and Throat Procedure
- Trial name
- NCT05067647
- Testing
- ENSEAL X1 Curved Jaw Tissue Sealer
- Where
- 6 sites in United States, Japan and 2 more
- Volunteers
- 94 people
- Sponsor
- Ethicon Endo-Surgery
Gastric Procedures, Lung Resection Procedures
Study of ECHELON ENDOPATH(TM) Staple Line Reinforcement
This prospective, single-arm, multi-center evaluation will collect clinical data in a post-market setting. The two types of procedures studied will be gastric and thoracic.
- Trial name
- NCT04544865
- Testing
- Staple Line Reinforcement
- Where
- 8 sites in United States
- Volunteers
- 240 people
- Sponsor
- Ethicon Endo-Surgery
Ear Mold Impression Procedure
Clinical Performance Evaluation of 3D Ear Canal Scanning Technology
Study participants will undergo ear canal impressions in a standard of care protocol utilizing two methodologies: 3D ear scanning using a commercially-available ear scanning device, and conventional silicone impression material.
- Trial name
- NCT05000047
- Testing
- 3D ear scanner, Conventional silicon ear impressions
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- Sonova AG
Pulmonary Surgical Procedures
Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection
This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 133Xe scintigraphy for the evaluation of pulmonary function in patients being evaluated for lung resection.
- Trial name
- NCT03417687
- Testing
- 129Xe MRI, 133 Xe scintigraphy
- Where
- 3 sites in United States
- Volunteers
- 38 people
- Sponsor
- Polarean, Inc.
Endovascular Procedures
Safety and Accuracy of the Saranas EBBMS for the Detection of Endovascular Procedure Related Bleeding Events
To evaluate the safety and accuracy of the Saranas EBBMS for the detection of access site related internal bleeding events during large-bore endovascular procedures.
- Trial name
- NCT03621202
- Testing
- Saranas Early Bird Bleed Monitoring System (EBBMS)
- Where
- 5 sites in United States
- Volunteers
- 66 people
- Sponsor
- Saranas, Inc.
Post Surgical Incisions From Abdominoplasty Procedures
Clinical Evaluation of the GLYDe Dressing for Post-surgical Incision Care
This study will evaluate a new dressing to be used for post-incision care for abdominoplasty patients. The hypothesis is that this dressing will minimize scar formation.
- Trial name
- Mona Lisa (NCT00766727)
- Testing
- GLYDe Dressing
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- Neodyne Biosciences, Inc.
Claustrophobia, Complication of Diagnostic Procedure
Comfort Talk and Economic Outcomes in MRI
Annually, an estimated 700,000 patients do not complete their scheduled MRI scans because of claustrophobia or inability to hold still.
- Trial name
- ComfortTalk® (NCT02427737)
- Testing
- Comfort Talk® Training
- Where
- 3 sites in United States
- Volunteers
- 12 people
- Sponsor
- Hypnalgesics, LLC
Diagnostic and/or Interventional Radiology Procedures
Angio-Seal Interventional Radiology (IR) Registry
The purpose of this study is to collect data on the standard of care use of the St. Jude Medical (SJM) Angio Seal™ Evolution™ and V-Twist Integrated Platform (VIP) Devices in diagnostic and/or interventional radiology patient…
- Trial name
- NCT01222104
- Where
- 10 sites in United States
- Volunteers
- 634 people
- Sponsor
- Abbott Medical Devices
Colonoscopy Procedure
Evaluation of the Performance of the Motus Cleansing System
The purpose of this study is evaluate the Motus GI Colon Cleansing system performance.
- Trial name
- MSC (NCT02161536)
- Testing
- Motus Cleansing System
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Motus GI Medical Technologies Ltd
Hypoglycemia, Complications of Bariatric Procedures
Delivery of G-Pump™ (Glucagon Infusion) From an OmniPod® to Prevent Hypoglycemia in Post-Bariatric Surgery Patients
The primary objective of this study is to test an optimized control system for sensor-guided (physician administered) delivery of glucagon, and test Proof-of-Concept (POC) in a clinical setting in patients with severe…
- Trial name
- NCT02733588
- Testing
- G-Pump™ (glucagon infusion)
- Where
- United States
- Volunteers
- 8 people
- Sponsor
- Xeris Pharmaceuticals
Iliac Crest Harvesting Procedure-Bone Void Filler
Study Performance of The Plexur P™ Bone Void Filler Device in Patients Undergoing Iliac Crest Harvesting Procedures
The purpose of this study is to determine if Plexur P grows bone in the iliac crest (where bone was removed or "harvested") for the back surgery. The study will be focusing on patients who require back surgery.
- Trial name
- NCT00837473
- Testing
- Plexur-P used as a Bone Void Filler in Iliac Crest Harvesting Procedures
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Osteotech, Inc