A Study for Ureter Visualization, Using ASP5354 in Subjects Undergoing Laparoscopic/Minimally Invasive Colorectal Surgery

Phase 2 Completed 13 enrolled Astellas Pharma Inc

RandomizedParallel-groupOpen-labelOther

Summary

The primary purpose of this study was to determine the optimal dose of ASP5354 for ureter visualization in participants undergoing laparoscopic/minimally invasive colorectal surgery This study also investigated the safety, tolerability and the pharmacokinetics of ASP5354 in participants undergoing laparoscopic/minimally invasive colorectal surgery.

Timeline

Start: 2020-10-06
Primary completion: 2021-11-18
Completion: 2021-11-29

Publications

Albert M, Delgado-Herrera L, Paruch J, Gerritsen-van Schieveen P, Kishimoto T, Takusagawa S, Cai N, Fengler J, Raizer J. Pudexacianinium (ASP5354) chloride for ureter visualization in participants undergoing laparoscopic, minimally invasive colorectal surgery. Surg Endosc. 2023 Sep;37(9):7336-7347. doi: 10.1007/s00464-023-10193-9. Epub 2023 Jul 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	pudexacianinium	Diagnostic / imaging agent	0.3 mg	Intravenous
Subject	pudexacianinium	Diagnostic / imaging agent	1 mg	Intravenous
Subject	pudexacianinium	Diagnostic / imaging agent	3 mg	Intravenous

Indications

No indication recorded.