Clinical trials: Fluorescence
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
Hepatocellular Carcinoma (HCC)
Hepatocellular Carcinoma 3 Gene Methylation Combination Detection Kit (PCR Fluorescent Probe Method) Multicenter Clinical Trial
This clinical trial aims to systematically evaluate the clinical performance and accuracy of the HepaAiQ test kit, a multi-gene methylation assay based on PCR with fluorescent probe detection.
- Trial name
- NCT06842563
- Where
- China
- Volunteers
- 900 people
- Sponsor
- Singlera Genomics Inc.
Intraoperative Ureter Visualization, Abdominolpelvic Surgery
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery in People With or Without Kidney Disease
The ureter is the tube that carries urine from the kidneys to the bladder. It is difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious.
- Trial name
- NCT05999747
- Testing
- pudexacianinium chloride
- Where
- 12 sites in United States
- Volunteers
- 95 people
- Sponsor
- Astellas Pharma Global Development, Inc.
Hypersensitivity Reactions
Post-market Safety Study of LUMISIGHT
This study is a prospective, multi-center, observational post-market safety study evaluating the incidence of anaphylaxis and hypersensitivity reactions associated with LUMISIGHT (pegulicianine) administration in adults with…
- Trial name
- NCT07572162
- Where
- 2 sites in United States
- Volunteers
- 1,500 people
- Sponsor
- Lumicell, Inc.
Head and Neck Surgery
Feasibility and Efficacy Study for Bevonescein-Assisted Nerve Visualization in Head & Neck Surgery
A Part 1 Phase 2 feasibility study to characterize the feasibility of using the REVEAL 475 system by obtaining surgeon perspective on illumination and ease of use.
- Trial name
- NCT06227585
- Testing
- REVEAL 475 System, Bevonescein
- Where
- United States
- Volunteers
- 155 people
- Sponsor
- Alume Biosciences, Inc.
Bladder Cancer
A Randomized, Comparative Study of Hexvix Fluorescence Cystoscopy and Standard Cystoscopy in Patients With Non-invasive Bladder Cancer
The main objective of the study is to compare the 1-year recurrence rate of Hexvix assisted Transuretheral Resection of the Bladder (TURB) to standard white light TURB in patients with suspicion of non-invasive bladder cancer.
- Trial name
- NCT00412971
- Testing
- Hexvix, Standard white light cystoscopy
- Where
- 2 sites in Denmark
- Volunteers
- 233 people
- Sponsor
- Photocure
Gallbladder Disease, Biliary Colic
Fluorescence Imaging on the da Vinci Surgical System for Intra-operative Near Infrared Imaging of the Biliary Tree (up to 2-weeks Post-operatively)
The investigators hypothesize that the da Vinci Fluorescence Imaging Vision System provides real-time endoscopic near infrared fluorescence imaging of the biliary anatomy as defined as identifying biliary vessels; either cystic…
- Conditions
- Gallbladder Disease, Biliary Colic, Gallstones
- Trial name
- NCT01410734
- Testing
- Indocyanine green (ICG)
- Where
- 2 sites in Italy, Switzerland
- Volunteers
- 72 people
- Sponsor
- Intuitive Surgical
Breast Cancer, Lymph Node Mapping
A Study Assessing the Safety and Effectiveness of IC2000 and SPY Fluorescence Imaging Systems (SPY-PHI) in the Visualization of Lymphatic Vessels and Identification of Lymph Nodes During Sentinel Lymph Node Biopsy in Subjects With Breast Cancer
This is a prospective, open label, multicenter, non-inferiority within-patient study to determine the effectiveness of IC2000 (Indocyanine Green (ICG) for Injection) and the SPY Portable Handheld Imaging System (SPY-PHI) as an…
- Conditions
- Breast Cancer, Lymph Node Mapping, Sentinel Lymph Node Biopsy
- Trial name
- FILM-B (NCT03200704)
- Testing
- IC2000 and SPY-PHI, Tc-99m radioactive colloid and Gamma Probe
- Where
- 7 sites in United States, Canada
- Volunteers
- 152 people
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker
Malignant Glioma
Study of NPC-07 for Fluorescence-guided Resection of Malignant Gliomas
The aim of the present Phase III study is to assess the positive predictive value of NPC-07 (5-aminolevulinic acid hydrochloride) induced tissue fluorescence, safety and pharmacokinetics following a single dose of NPC-07 orally…
- Trial name
- NCT01167322
- Testing
- NPC-07 for oral administration
- Where
- 3 sites in Japan
- Volunteers
- 45 people
- Sponsor
- Nobelpharma
Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure
Leica Microsystems Sponsored PMCF Study to Collect and Confirm Clinical Data on the Performance of the GLOW400 Device When Used in Accordance With Its Intended Use
This post-market clinical follow-up (PMCF) study aims to confirm the safety and performance of the GLOW400 surgical microscope accessory when used in conjunction with the ARveo8x surgical microscope.
- Conditions
- Suspected Grade III and IV Gliomas Requiring Surgical Intervention, Neurosurgical Procedure, Glioma, Glioblastoma (GBM)
- Trial name
- IMED-GLOW400 (NCT07366892)
- Testing
- GLOW400 is a digital surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.
- Where
- 2 sites in Portugal, Switzerland
- Volunteers
- 37 people
- Sponsor
- Leica Microsystems (Schweiz) AG
Technical Capabilities of the Device
Retinal Metabolic Imaging in a Diverse Population
This research project aims to evaluate use in a clinical context of a novel imaging instrument, the Metabolic Hyperspectral retina Camera (MHRC) from Optina Diagnostics.
- Trial name
- NCT03442816
- Testing
- MHRC Camera
- Where
- Canada
- Volunteers
- healthy volunteers welcome
- Sponsor
- Optina Diagnostics Inc.
Breast Cancer, Head and Neck Squamous Cell Carcinoma
A Study to Evaluate ONM-100, an Intraoperative Fluorescence Imaging Agent for the Detection of Cancer
This study is to evaluate diagnostic performance, safety and timing of post-dose imaging of ONM-100, an intraoperative fluorescence imaging agent for the detection of cancer in patients with solid tumors undergoing routine…
- Conditions
- Breast Cancer, Head and Neck Squamous Cell Carcinoma, Colorectal Cancer, Prostate Cancer
- Trial name
- NCT03735680
- Testing
- ONM-100
- Where
- 3 sites in United States
- Volunteers
- 30 people
- Sponsor
- OncoNano Medicine, Inc.
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.
Retinal Disease
Study Comparing the P200TxE and P200DTx
The study evaluates image quality between two devices.
- Trial name
- NCT03964831
- Testing
- P200TxE, P200DTx
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- Optos, PLC
Acute Kidney Injury
Tolerability and Background Fluorescence of the MediBeacon Transdermal GFR Measurement System
This study is designed to evaluate background fluorescence of participants of different ages, gender, and skin color. In addition, 48-hour tolerability of the sensor and adhesive will be evaluated.
- Trial name
- NCT03810833
- Testing
- Brilliance device sensor
- Where
- United States
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- MediBeacon
Parotid Neoplasm, Thyroid Neoplasms
Bevonescein to Highlight Nerves in Patients Undergoing Head & Neck Surgery
Bevonescein to Highlight Nerves in Patients Undergoing Head \& Neck Surgery
- Conditions
- Parotid Neoplasm, Thyroid Neoplasms, Head and Neck Neoplasms, Surgery
- Trial name
- NCT04420689
- Testing
- Bevonescein
- Where
- 3 sites in United States
- Volunteers
- 27 people
- Sponsor
- Alume Biosciences, Inc.
Ureter Injury
IS-001 Injection in Patients Undergoing Robotic-Assisted Colorectal Surgery
This study evaluates the safety and efficacy of intravenous injection of IS-001 to aid in intraoperative ureter structure delineation
- Trial name
- NCT07346066
- Testing
- filricianine
- Where
- 9 sites in United States
- Volunteers
- 146 people
- Sponsor
- Intuitive Surgical
Frozen Sections, Indocyanine Green
Multi-center Study on CCeLL-In Vivo's Clinical Efficacy for Intraoperative Brain Tumor Diagnosis.
The primary objective of this study is to demonstrate the non-inferiority of cCeLL compared to frozen section analysis. The investigational device is intended for use with indocyanine green (ICG) for fluorescence imaging as an…
- Conditions
- Frozen Sections, Indocyanine Green, Brain Tumor
- Trial name
- PRECISION (NCT06867978)
- Testing
- cCeLL In vivo, Indocyanine Green
- Volunteers
- 100 people
- Sponsor
- VPIX Medical
Helicobacter Pylori Gastritis
Triple Therapy Versus Levofloxacin-based Therapy for Helicobacter Pylori Eradication in Mexico.
The goal of this trial is to compare the non-inferiority efficacy and safety of two different treatment schemes: pantoprazole 80 mg + levofloxacin 500 mg + azithromycin 500 mg once daily (PLA, test) vs.
- Trial name
- NCT02726269
- Testing
- CLA (Clarithro+Lanso+Amoxi), PLA (Panto+Levoflox+Azithro)
- Volunteers
- 230 people
- Sponsor
- Asofarma de México S.A de C.V.
Intraoperative Ureter Injury
Open-label Study to Evaluate Nerindocianine as a Surgical Aid in Ureter Delineation During Minimally Invasive Surgery
Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery…
- Trial name
- NCT04636567
- Testing
- Nerindocianine for injection
- Where
- 2 sites in United States
- Sponsor
- Li-Cor, Inc.