Clinical trials: Intraoperative
Pancreatic Cancer
Initial Feasibility Study to Treat Borderline Resectable Pancreatic Cancer With a Planar LDR Source
Initial study to evaluate local control and the preferred method of attachment of the CivaSheet in the setting of suspected close or positive margins at the time of surgical tumor removal.
- Trial name
- NCT02843945
- Testing
- Directional Brachytherapy Source Implant
- Where
- 6 sites in United States
- Volunteers
- 80 people
- Sponsor
- CivaTech Oncology
Frozen Sections, Indocyanine Green (ICG)
A PROSPECTIVE, SINGLE-CENTERED, ASSESSOR-BLINDED STUDY TO EVALUATE THE CLINICAL EFFICACY OF THE PROPOSED CELL/TISSUE HISTOPATHOLOGY PROCESSOR CCELL (CONFOCAL FLUORESCENCE ENDOMICROSCOPY) FOR INTRAOPERATIVE DIAGNOSIS IN BRAIN TUMORS
The primary objective of this single-center study is to demonstrate the performance of cCeLL, used in real time, compared to frozen section analysis.
- Conditions
- Frozen Sections, Indocyanine Green (ICG), Brain Tumor
- Trial name
- NCT07254845
- Testing
- cCeLL In vivo, Indocyanine Green
- Volunteers
- 30 people
- Sponsor
- VPIX Medical
Blood Loss, Surgical
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device.
- Trial name
- CLOT (NCT02359994)
- Testing
- PerClot Polysaccharide Hemostatic System, Arista AH
- Where
- United States
- Volunteers
- 324 people
- Sponsor
- Artivion Inc.
Breast Cancer
Intraoperative Detection of Residual Cancer in Breast Cancer
This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM imaging device), in…
- Trial name
- NCT03321929
- Testing
- LUM Imaging System
- Where
- 16 sites in United States
- Volunteers
- 234 people
- Sponsor
- Lumicell, Inc.
Sarcoma
Registry of Sarcoma Patients Treated With Permanently Implantable LDR CivaSheet®
This patient study will determine the safety and toxicity of a permanently implantable brachytherapy source - CivaSheet® - which is designed to deliver a therapeutic dose of low dose rate (LDR) radiation with polymer encased…
- Trial name
- NCT04033081
- Testing
- CivaSheet
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- CivaTech Oncology
Cataract, Aphakia
Visual and Refractive Outcomes of The ClarVista HARMONI™ Modular Intraocular Lens System (HMIOL)
The purpose of this study was to evaluate visual and refractive outcomes with the use of the HARMONI™ Modular Intraocular Lens (HMIOL) System implantation, assembly, and optic exchange in subjects undergoing cataract surgery.
- Trial name
- NCT03681886
- Testing
- Harmoni Modular Intraocular Lens, Optic Exchange
- Volunteers
- 150 people
- Sponsor
- ClarVista Medical
Hemorrhage, Blood Loss
Clinical Investigation Evaluating a New Autotransfusion Device in Cardiac Surgery
Blood transfusion is at the heart of the therapeutic arsenal when there is a hemorrhage and/or blood loss during a surgery. There are two types of transfusion: the homologous one (blood from a compatible donor) and the autologous…
- Conditions
- Hemorrhage, Blood Loss, Surgical Blood Loss
- Trial name
- i-TRANSEP (NCT04588350)
- Testing
- i-SEP autotransfusion system
- Where
- 5 sites in France
- Volunteers
- 50 people
- Sponsor
- i-SEP
Ureter Injury
Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
The goal of this clinical trial is to learn if Lumitrace and the KARL STORZ POWER LED BLUE System can be used for anatomic visualization of the ureters in participants undergoing laparoscopic abdominopelvic surgery.
- Trial name
- NCT07080008
- Testing
- Lumitrace, KARL STORZ POWER LED BLUE System
- Where
- United States
- Volunteers
- 10 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Lung Cancers
A Single Dose, Open-Label, Dose-escalation Study of the Safety and Imaging Characteristics of LS301-IT for Intraoperative Imaging of Lung Cancer
The aim of this Phase 1b study is to investigate the safety and fluorescence signal of a single dose of LS301-IT, a novel fluorescence imaging agent developed by Integro Theranostics (IT), administered by slow intravenous (IV)…
- Trial name
- NCT06713564
- Testing
- LS301-IT
- Where
- United States
- Volunteers
- 24 people
- Sponsor
- Integro Theranostics
Blood Loss, Surgical
Pre-surgical Evaluation for the Quantra System in Adult Patients Undergoing Cardiac Surgery
This study will evaluate the performance of the Quantra System comprised of the Quantra Hemostasis Analyzer with the QPlus Cartridge in patients taking anitplatelet medication that are scheduled to undergo cardiac surgery.
- Trial name
- NCT03931031
- Testing
- Quantra System
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- HemoSonics LLC
Ovarian Cancer
Phase 2 Study of OTL38 for Intra-operative Imaging of Folate Receptor-alpha Positive Ovarian Cancer
This study is being done to: test the safety of OTL38 see if OTL38 helps light up the cancer when viewed with the special camera system test the safety of the special camera system for use along with OTL38 during surgery
- Trial name
- NCT02317705
- Testing
- OTL38, Near infrared camera imaging system, Laparotomy
- Where
- 4 sites in United States
- Volunteers
- 48 people
- Sponsor
- On Target Laboratories, LLC
Parkinson
Intraoperative Investigation of a Directional Lead and Local Field Potentials for the Optimization of Stimulation Efficacy
The current study aims to explore the functional use of LFPs recorded intraoperatively for the optimization of a directional DBS lead programming Aim-1: To determine whether intraoperative LFPs recorded from the segmented DBS…
- Trial name
- INVENT (NCT03630302)
- Testing
- DBS
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Abbott Medical Devices
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
Anesthesia
The Effect of Low Dose Intra-operative Ketamine on Closed-loop Controlled General Anesthesia
Closed-loop control of anesthesia involves using feedback from a measure of clinical effect to continuously adjust drug infusion rates.
- Trial name
- NCT03009409
- Testing
- Ketamine Injectable Solution
- Where
- Canada
- Volunteers
- 60 people
- Sponsor
- NeuroWave Systems Inc.
Intraocular Lens Replacement
Safety and Efficacy of OMS302 in Subjects Undergoing Intraocular Lens Replacement With Phacoemulsification
The purpose of this study is to determine the safety and efficacy of OMS302 (the study drug) for maintaining intraoperative mydriasis in individuals undergoing Intraocular Lens Replacement (ILR) surgery.
- Trial name
- OMS302-ILR-003 (NCT01454063)
- Testing
- OMS302
- Where
- 16 sites in United States
- Volunteers
- 405 people
- Sponsor
- Omeros Corporation
Lung Neoplasms, Lung Cancer
ELUCIDATE: Enabling Lung Cancer Identification Using Folate Receptor Targeting
This is a phase 3, multi-center, single dose, open-label, exploratory study in suspected lung cancer patients scheduled to undergo endoscopic or thoracic surgery per CT/PET/MRI or other imaging based on standard of care.
- Trial name
- Elucidate (NCT04241315)
- Testing
- OTL38 for Injection, Near infrared camera imaging system
- Where
- 12 sites in United States
- Volunteers
- 112 people
- Sponsor
- On Target Laboratories, LLC
Osteoarthritis
Prospective Clinical Study Evaluating Tibiofemoral Rotational Alignment Using Intraoperative Sensing During Total Knee Arthroplasty (TKA)
The objectives of the study are twofold: 1) Evaluate how intra-operative sensing may assist the surgeon with tibiofemoral rotational alignment by testing the precision and variability of setting tray rotation to the mid-third of…
- Trial name
- NCT02286739
- Testing
- TKA with "Verasense", TKA without "Verasense"
- Where
- 6 sites in United States
- Volunteers
- 500 people, healthy volunteers welcome
- Sponsor
- Orthosensor, Inc.
Blood Loss, Surgical, Postoperative Hemorrhage
Effect of Aprotinin on Transfusion Requirements in Patients Undergoing Elective Spinal Fusion Surgery
The objective of this study is to evaluate the safety and efficacy of aprotinin as compared to placebo, in reducing the need for blood transfusion in adult subjects undergoing elective spinal fusion surgery involving 3 to 7…
- Trial name
- NCT00327379
- Testing
- Trasylol (Aprotinin, BAYA0128)
- Where
- 14 sites in Canada, Germany and 1 more
- Volunteers
- 54 people
- Sponsor
- Bayer
Gastric Cancer, Pancreatic Cancer
Use of the EnLightTM and LightPathTM Imaging Systems in Gastrointestinal Tumour Surgery
This study will evaluate the performance of the EnLightTM and LightPathTM Imaging Systems in detecting tumour lesions in patients with gastric, pancreas, bile duct or duodenal cancer.
- Conditions
- Gastric Cancer, Pancreatic Cancer, Bile Duct Cancer, Duodenal Cancer
- Trial name
- CLIO (NCT02446379)
- Testing
- The marketed product 2-5 MBq/kg 18F-fluorodeoxyglucose, EnLightTM, LightPathTM Imaging System
- Where
- Hungary
- Sponsor
- Lightpoint Medical Limited
Blood Loss, Surgical
Quantra QPlus in Pediatric Cardiovascular Procedures
This study will evaluate the performance of the Quantra System with the QPlus Cartridge in pediatric patients undergoing cardiovascular procedures.
- Trial name
- NCT07597278
- Testing
- Quantra System
- Where
- 3 sites in United States
- Volunteers
- 160 people
- Sponsor
- HemoSonics LLC