Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-31 @ 1:36 AM
Study NCT ID:
NCT05754333
Status:
COMPLETED
Last Update Posted:
2025-10-09
First Post:
2023-02-22
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Find Out if ASP5354 Can Clearly Help Show the Ureter During Surgery
Sponsor:
Astellas Pharma Global Development, Inc.
Organization:
Study Overview
Official Title:
A Phase 3, Multicenter, Prospective, Randomized, Open-label Study for Intraoperative Ureter(s) Visualization When Using ASP5354 With Near Infrared Fluorescence (NIR-F) Imaging in Participants Undergoing Minimally Invasive and Open Abdominopelvic Surgeries
Status:
COMPLETED
Status Verified Date:
2025-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The ureter was the tube that carries urine from the kidneys to the bladder. It was difficult for surgeons to see the ureter during abdominal surgery. This could lead to injuring the ureter which, although rare, could be serious. This study was about a potential new medical dye, called ASP5354. This dye was injected into the person at the start of surgery and was detected in the ureter. This was done by an imaging machine which had an option called near infrared fluorescence, or NIR-F. Together they showed live images of specific parts of the body. In this study, ASP5354 was used with an imaging machine with a NIR-F option to show live images of the ureter during surgery. People with kidneys that work properly and those with kidney problems could take part. The main aim of the study was to find out how clearly the ureter could be seen with ASP5354 during surgery in adults whose kidneys work properly or who have mild kidney problems. To do this, the surgeons injected ASP5354 into the person having surgery. Then, the surgeons compared images of the ureter with an imaging machine using normal white light and with the NIR-F option. Imaging using normal white light was the standard way surgeons see the ureter during surgery. People 12 years or older who were going to have certain abdominal surgeries could take part. Everyone taking part received ASP5354 during surgery, but how the imaging was done depended on which group they are in. Before surgery, the adults taking part whose kidneys work properly or who have mild kidney problems were assigned into 1 of 2 groups by chance alone. Images of the ureter were checked in 1 group using normal white light and the other group using normal white light and NIR-F. People 18 years and older with more severe kidney problems and all people under 18 years old were not be assigned to 1 of 2 groups: all images of the ureter were checked using normal white light and NIR-F. At the start of surgery, the surgeon injected ASP5354 into the person having surgery, then started recording a video. Then, after 30 minutes, the surgeon recorded how well the ureter could be seen. This was done by either using normal white light, or normal white light and NIR-F, depending which group each person having surgery was assigned to. For the group to be checked with normal white light and NIR-F, the surgeon did this every 30 minutes until the end of surgery. For the group to be checked with normal white light only, the surgeon did this after the first 30 minutes. During the study, people visited the study hospital 3 times. The first visit was to check if they can take part in the study. People were asked about their medical history, have had a medical examination, and their vital signs checked (blood pressure and pulse rate). Also, they had some blood and urine tests. For women and girls this may included a pregnancy test. People had their surgery at the second visit. This was within 28 days of their first visit. This included having some blood and urine tests before, during, and after surgery. Also, they had a medical examination, an electrocardiogram (ECG) to check their heart rhythm, and had their vital signs checked. After surgery, people returned to the clinic 15 days later for a final check-up. They were asked if they have had any medical problems. Also, they had a medical examination, had their vital signs checked, and had some blood and urine tests.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: