Phase 4 N=130 Evaluation of Ureteral Patency in the Post-indigo Carmine Era
Ureteral Patency
Primary: Visual Analog Scale (VAS) — 48; 20; 0; 28 score on a scale
Clinical Trial Search
Completed trials with posted results — search by concept, filter by the parameters that matter at the bedside.
Phase 3 N=121 3,3'-Dioxo-2,2'-Bisindolylidene-5,5'-Disulfonate Disodium 0.8% Solution as an Aid for Ureteral Patency
Ureter Injury
Primary: Urine Jet Conspicuity Score — 4.1; 4.2; 2.5 score on a scale — p=<0.0001
N/A N=37 Evaluation of Sodium Fluorescein Use During Intraoperative Cystoscopy After Total Laparoscopic Hysterectomy
Ureteral Injury
Primary: Quality of Ureteral Efflux Coloration With Sodium Fluorescein Collected With Dedicated Questionnaire — 23; 4; 1; 1 Participants
N/A N=176 Evaluation of Ureteral Jets on Cystoscopy
Injury of Ureter
Primary: Ureteral Jet Visibility — 22; 35; 27; 41 Participants
N/A N=100 The Use of Fluorescent Imaging for Intraoperative Cholangiogram During Laparoscopic Cholecystectomy
Cholelithiasis · Cholecystitis · Pancreatitis Biliary
Primary: Operative Time — 51.6; 44.4 minutes
N/A N=14 Intraoperative Folate Targeted Fluorescence in Renal Cell Carcinoma
Renal Cell Carcinoma
Primary: Number of Participants With Presence of Fluorescence of cT1 RCC in Partial Nephrectomy Specimens — 10 Participants
Phase 3 N=107 A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
Intraoperative Ureter Visualization · Abdominolpelvic Surgery
Primary: Investigator Conspicuity Score Difference in Ureter Between WL and NIR-F at 30 Minutes [Adult (Normal/Mild): WL/NIR-F] — 2.7; 4.3 score on a scale — p=<0.001
N/A N=125 Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring
Vocal Cord Function in Neck Procedures
Primary: Frequency of Congruence of Nerve Integrity and Vocal Cord Functions — 68; 13; 17; 10 nerves at risk
Phase 2 N=13 A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery
Laparoscopic/Minimally Invasive Colorectal Surgery
Primary: Percentage of Participants With Successful Anatomical Visualization of the Index Ureter(s) — 66.7; 100.0; 100.0; 66.7 percentage of participants
N/A N=66 "Laparoscopic" Cystoscopy Versus Traditional Cystoscopy
Lower Urinary Tract Injury
Primary: Time Required to Perform Procedure (in Seconds) — 137; 451 seconds
N/A N=95 Impact Ureteral Sheath Design During Ureteroscopy
Renal Stone · Nephrolithiasis · Urolithiasis
Primary: Number of Participants With Successful Sheath Placement — 37; 39 Participants
Phase 2 N=60 Low Dose ICG for Biliary Tract and Tumor Imaging
Cholecystitis · Hepatocellular Carcinoma · Liver Metastases
Primary: Quantitative Assessment - Bile Duct-to-liver Fluorescence Intensity Ratio — 2.7; 0.7 ratio
N/A N=99 Near Infrared Fluorescence Cholangiography (NIRF-C) During Cholecystectomy
Cholecystitis
Primary: Complications Related to ICG — 0; 0 % of Participants with Complications
N/A N=677 Fluorescent Cholangiography vs White Light for Bile Ducts Identification
Cholecystitis · Cholelithiasis
Primary: Detection Rate of Common Bile Duct Before and After Dissection Using Near Infra-red Light — 64; 157; 159; 243 Participants
N/A N=35 Ultravision Visual Clearing System in Laparoscopic Hysterectomy and Myomectomy
Pain · Hysterectomy · Myomectomy
Primary: Quality of Surgical Field Visualization — 9; 1; 5; 2 participants
N/A N=53 Evaluation of 3D Visualization for Total Colectomy
Ulcerative Colitis
Primary: Operating Time — 75.3; 82.7 minutes
N/A N=23 Proposal for Intraoperative Administration of Intravenous Indocyanine Green to Evaluate Position of the Optic Canal, Position of the Internal Carotid Arteries, Tumor Vascularization, and Vessel Encasement in Endoscopic Endonasal Cranial Base Surgery
Skull Base Neoplasms · Skull Neoplasms · Bone Neoplasm
Primary: ICG Fluorescence Ratio — 0.92; 0.82 Ratio
N/A N=11 Contrast Enhanced Intraoperative Ultrasound for Detection and Characterization of Renal Mass Undergoing Open Partial Nephrectomy
Kidney Cancer
Primary: Successful Capture of IO-CEUS Images — 10 participants
N/A N=108 Trial Assessing Renal Damage During Ureteroscopy
Nephrolithiasis
Primary: Change in Kidney Injury Molecule-1 (KIM-1) — 0.01077; 0.01228; 0.0246; 0.02413 ng/ml
N/A N=491 Urinary Retention After Laparoscopic Inguinal Hernia Repair: Comparing the Use of the Intraoperative Urinary Catheter
Inguinal Hernia
Primary: Number of Participants With Post Operative Urinary Retention — 23; 21 Participants
N/A N=107 Phenazopyridine for Confirmation of Ureteral Patency
Cystoscopy
Primary: Time to Visualize Ureteral Urine Flow Intraoperatively Measured by Timing in the Operating Room — 160; 173 seconds — p=0.77
Phase 4 N=242 Cytoscopic Antibiotic Irrigant to Reduce Postoperative Urinary Tract Infection
Urinary Tract Infections
Primary: Urinary Tract Infection — 11; 12 UTI
Early Phase 1 N=100 Efficacy of Fluorescein Visualization of the Uterus in Detecting Endometrial Cancer Invasion
Endometrial Cancer
Primary: Percentage of Participants With Positive Predictive Value and Negative Predictive Value From Fluorescein Visualization — 71; 100; 85; 90 percentage of participants
N/A N=234 Intraoperative Cone-beam CT for Percutaneous Nephrolithotomy
Nephrolithiasis
Primary: "Second Look" Rate — 4; 56; 56; 118 Participants — p=<0.01
Phase 2 N=94 Toradol to Reduce Ureteroscopic Symptoms Trial
Urinary Lithiasis · Kidney Diseases · Kidney Stone
Primary: Post-operative Pain — 22; 30 milligram morphine equivalent
N/A N=108 Occlusion Balloon vs. 5FR Ureteral Catheter
Kidney Stones
Primary: Number of Participants With Ureteral Stone Fragments Identified Endoscopically — 2; 8 Participants
N/A N=46 Effects of Flexible Ureteroscopy on Renal Blood Flow
Circulatory; Change
Primary: Peak Systolic Velocities (PSV) Measurement by Renal Doppler Ultrasound (US) Examination Evaluating the Effects of Flexible Ureteroscopy (F-URS) on Renal Blood Flow by…
N/A N=10 Eye Gaze Guidance Evaluation in Phantoms
Kidney Stones
Primary: Completeness of Kidney Exploration — 71; 67 percentage of kidney seen
N/A N=9 Intraoperative Evaluation of Axillary Lymphatics
Lymphedema · Surgery · Breast Cancer
Primary: Number of Cases Where Lymphatics Were Visualized by Blue Dye Versus by ICG Using the OnLume Imaging System — 5; 9 Participants
N/A N=20 Merits of Performing a Modified Template Retroperitoneal Lymph Node Dissection
Cancer of the Urinary Tract
Primary: Number of Participants With Pathologically Proven Lymph Node Metastasis — 1 participants