Clinical trials: Intraoperative
Low Vision, Age Related Macular Degeneration
Early Feasibility Study Using IOPCL MAG to Improve Near Vision in ARMD Subjects
This early feasibility study aims to improve near vision in subjects 55 years or older who have a clinical diagnosis of Age-Related Macular Degeneration.
- Trial name
- NCT04984590
- Testing
- IOPCL AMD MAG
- Where
- United States
- Volunteers
- 9 people, healthy volunteers welcome
- Sponsor
- OnPoint Vision Inc
Intraoperative Neurophysiological Monitoring
MINDZ-- Minimally Invasive Approach Pilot Study
This clinical investigation is a pilot, first-in-human (FIH) study designed to demonstrate proof of concept, safety, and functional performance of the MINDZ subdural electrode grid when used in relevant neurosurgical settings.
- Trial name
- MINDZ-MAP (NCT07543406)
- Testing
- MINDZ Subdural Electrode Grid
- Where
- Switzerland
- Volunteers
- 5 people
- Sponsor
- Neurosoft Bioelectronics SA
Cataract, Corneal Astigmatism
ClarVista HARMONI Toric Trial With Intraoperative Exchange
The purpose of this study was to demonstrate the safety and effectiveness of the HARMONI® Modular Intraocular Lens System with a toric optic in subjects with pre-existing corneal astigmatism in need of cataract surgery.
- Conditions
- Cataract, Corneal Astigmatism, Aphakia
- Trial name
- NCT03054649
- Testing
- HARMONI® Modular Intraocular Lens System, Intraoperative optic exchange
- Where
- 2 sites in Mexico, Philippines
- Volunteers
- 44 people
- Sponsor
- ClarVista Medical
Glioma, Glioblastoma Multiforme
Phase IIa Safety and Light Dose-escalation Study in Patients With Primary or Recurrent/High-grade Glioma Using the Litx™ System to Confirm the Zone of Tumor Destruction During the Intraoperative Treatment of Glioma
The pupose of this study is to demonstrate the safety of the Litx™ therapy and confirm the zone of tumor destruction with escalated light doses following intraoperative treatment of primary or recurrent glioma.
- Conditions
- Glioma, Glioblastoma Multiforme, Anaplastic Astrocytoma
- Trial name
- NCT00409214
- Testing
- LS11 (talaporfin sodium), Light source (interstitial light emitting diodes), Intraoperative placement of device in glioma
- Where
- Serbia
- Volunteers
- 18 people
- Sponsor
- Light Sciences Oncology
Breast Cancer
Feasibility Study of Intraoperative Imaging in Breast Cancer
For most breast cancer patients, surgery is the primary treatment. When patients undergo a lumpectomy, it is difficult for the surgeon to determine the extent of the tumor which results in incomplete tumor removal as determined…
- Trial name
- NCT02438358
- Testing
- LUM015, LUM 2.6 Imaging Device
- Where
- United States
- Volunteers
- 60 people
- Sponsor
- Lumicell, Inc.
Pancreatic Diseases, Bile Duct Diseases
SpyGlass Surgical Study
To document the clinical utility of diagnostic and/or therapeutic intraoperative endoscopy using a thin, single-use, flexible cholangiopancreatoscope To identify specific surgical procedures in which intraoperative use of a thin…
- Conditions
- Pancreatic Diseases, Bile Duct Diseases, Hepatic Disease
- Trial name
- NCT05822635
- Testing
- SpyGlass Discover Digital System or SpyGlass DS Direct Visualization System
- Where
- 5 sites in United States, China and 2 more
- Volunteers
- 34 people
- Sponsor
- Boston Scientific Corporation
Surgical Procedures, Operative
A Study Comparing ETHICON™ 4000 Stapler System With Standard of Care Stapling Devices in Adults Undergoing Gastric and Thoracic Procedures
The purpose of this study is to compare how well the ETHICON™ 4000 Stapler works as compared to the standard stapling devices by assessing how often air leaks and bleeding along the staple line occur during lung and stomach…
- Trial name
- NCT07744568
- Testing
- ETHICON™ 4000 Stapler System, Standard of Care Stapler and Reloads
- Volunteers
- 300 people
- Sponsor
- Ethicon Endo-Surgery
Blood Loss, Surgical
QStat in Liver Transplant
This study will assess the clinical performance of the Quantra System with the QStat Cartridge in the liver transplant population.
- Trial name
- NCT04114253
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- HemoSonics LLC
Breast Neoplasm Female, Breast Cancer
Fluorescence Imaging of Carcinoma During Breast Conserving Surgery
Breast conserving surgery (BCS) is performed on patients with breast cancer to resect and completely remove the cancer while conserving as much of the surrounding healthy tissue as possible.
- Trial name
- NCT04815083
- Testing
- Aminolevulinic Acid Hydrochloride, Eagle V1.2 Imaging System
- Where
- 7 sites in United States
- Volunteers
- 57 people
- Sponsor
- SBI ALApharma Canada, Inc.
Invasive Ductal Carcinoma, Ductal Carcinoma in Situ
Safety and Efficacy Study of the Xoft® Axxent® eBx® IORT System®
The purpose of this trial is to assess the safety and efficacy of the Xoft Axxent eBx System when used for single-fraction IORT in early stage breast cancer.
- Trial name
- NCT01644669
- Testing
- Intra-operative Radiation Therapy - IORT
- Where
- 24 sites in United States, Australia and 1 more
- Volunteers
- 1,200 people
- Sponsor
- Xoft, Inc.
Lung Cancer
A Study to Evaluate Pegsitacianine, an Intraoperative Fluorescence Imaging Agent for the Detection of Lung Malignancies
This Phase 2 study is an open-label, single-arm trial where each patient is his/her own "intrapatient" control. All patients will receive a single dose of pegsitacianine prior to standard of care surgery.
- Trial name
- NCT05048082
- Testing
- pegsitacianine, Tumor resection surgery
- Where
- 2 sites in United States
- Volunteers
- 24 people
- Sponsor
- OncoNano Medicine, Inc.
Focal Epilepsy, Intraoperative Monitoring
Evaluation of New Flexible High-density Intra-operative ECoG Electrodes for Epilepsy Surgery. ( EpiGrid )
The objective of this prospective interventional monocentric clinical investigation is to evaluate the feasibility and performance of the flexible high-density SOFT ECoG electrode grids, manufactured by Neurosoft Bioelectronics…
- Trial name
- EpiGrid (NCT06205160)
- Testing
- SOFT ECoG subdural grid electrode
- Where
- Netherlands
- Volunteers
- 12 people
- Sponsor
- Neurosoft Bioelectronics SA
Surgical Hemorrhage
A Phase III Study of Hemofence for Hemostasis in Patients With Uncontrolled Exudative Hemorrhage During Spinal Or Orthopedic Surgery
This Phase 3 study was conducted to evaluated the efficacy and safety of Hemofence compared with Floseal Hemostatic Matrix in patients undergoing spinal or orthopedic surgery who required hemostasis for exudative bleeding that…
- Trial name
- NCT07824024
- Testing
- Hemofence, Floseal hemostatic matrix
- Where
- 3 sites in South Korea
- Volunteers
- 172 people
- Sponsor
- BMI Korea
Diabetes Mellitus
Intraoperative Dexamethasone and Its Effect on Hyperglycemia
To study the effect of intra-operative dexamethasone on the management of post-operative blood sugar in diabetic patients.
- Trial name
- NCT03646916
- Testing
- Dexamethasone, No dexamethasone
- Where
- United States
- Sponsor
- Ascension Health
Intraoperative Complications
Hydroxyethyl Starch (130/0.4) for Intravascular Volume Therapy in Liver Transplantation
There are no standardized plasma volume replacement protocols during liver transplantation surgery. The current study is designed to compare efficacy, safety, and costs of perioperative volume replacement with Voluven…
- Trial name
- NCT00308100
- Testing
- Hydroxyethylstarch 130/0.4, 5% Albumin
- Where
- China
- Volunteers
- 53 people
- Sponsor
- Fresenius Kabi
Liver Transplantation, Infection
Efficacy and Safety of Basiliximab, Cyclosporine/Cyclosporine Microemulsion, and Steroids in Pediatric de Novo Liver Transplant Recipients Avoiding Intraoperative Steroids
Systemic infection is still a major concern in young children with liver transplantation. The approach of this study is to reduce the risk of systemic infections by avoiding intraoperative steroids (another class of…
- Trial name
- NCT00149890
- Testing
- Basiliximab, Cyclosporine/cyclosporine microemulsion, Steroid
- Where
- Germany
- Volunteers
- 77 people
- Sponsor
- Novartis
Hemorrhage
SURGICEL® Powder in Controlling Mild or Moderate Parenchymal or Soft Tissue Intraoperative Bleeding in Adult Subjects
This is a prospective, single arm, multicentre, multispecialty, post market, clinical study evaluating SURGICEL Powder as an adjunct to achieve haemostasis (control bleeding) when conventional methods of control are impractical…
- Trial name
- NCT03762200
- Testing
- SURGICEL Powder
- Where
- 8 sites in Belgium, United Kingdom
- Volunteers
- 103 people
- Sponsor
- Ethicon, Inc.
Anemia, Blood Loss, Surgical
An Observational Study of Blood Management Techniques in Oncology Surgical Treatment
The purpose of this study is to observe the methods used to manage blood loss in surgical procedures to remove tumors from patients with cancer and to determine if there is a relationship with the need for blood transfusions.
- Conditions
- Anemia, Blood Loss, Surgical, Neoplasms
- Trial name
- NCT00264095
- Testing
- Oncological surgery
- Where
- 11 sites in Netherlands
- Volunteers
- 488 people
- Sponsor
- Janssen-Cilag B.V.
Benign Brain Tumor, Malignant Brain Tumor
Evaluation of cCeLL-Ex Vivo Confocal Microscopy for Real-time Brain Tumor Diagnosis
Intra-operative evaluation of residual brain tumor currently relies on frozen-section histopathology, which typically requires 20-30 minutes for tissue processing and interpretation, prolonging operative time and increasing…
- Trial name
- cCeLLExvivo (NCT06098248)
- Testing
- cCeLL - Ex vivo
- Where
- 4 sites in Canada, South Korea
- Volunteers
- 285 people
- Sponsor
- VPIX Medical
Bunion
A Study to Evaluate Analgesic Efficacy and Safety of PRF-110 for Post-surgical Pain
PRF-110 is a viscous, yellowish clear oily solution of ropivacaine intended for administration into surgical sites to provide post-operative analgesia.
- Trial name
- NCT05773846
- Testing
- Ropivacaine
- Where
- 7 sites in United States
- Volunteers
- 428 people
- Sponsor
- PainReform LTD