Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06448143
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-07
First Post:
2024-05-20
Brief Title:
Indigotindisulfonate Sodium Injection USP as an Aid in the Determination of Ureteral Patency in Pediatric Patients
Sponsor:
Prove pharm
Organization:
Prove pharm
Study Overview
Official Title:
An Open-Label Multicenter Study to Evaluate the Safety Pharmacokinetics and Conspicuity of Bludigo When Used as an Aid in the Determination of Ureteral Patency in Pediatric Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
This is an open-label multicenter study to evaluate the safety pharmacokinetics and conspicuity of a weight-based Bludigo dose 005 mLkg rounded up if necessary to a minimum of 05 mL and not to exceed 25 mL when used as an aid in the determination of ureteral patency in pediatric patients
The study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States
Patients scheduled for urological or gynecological surgical procedures who are 17 years will be screened for participation
A minimum of 6 patients will be enrolled in each of the following three age groups birth to 6-years old 6 to 12 years old 12 to 17 years old
Screening will occur within 30 days before study drug administration Day of Surgery
After signing the informed consent review of inclusion and exclusion criteria will be performed The collection of medical history and concomitant medications the completion of a physical examination including vital signs measurement ECG and the collection of baseline laboratory testing samples must be collected within 14 days of day 1 will be completed during the screening period
On the Day of Surgery Day 1 patients will be evaluated for eligibility for treatment
To evaluate the efficacy outcomes each patient will be injected with a weight-based dose of Bludigo 005 mLkg rounded up if necessary to a minimum of 05 mL the maximum dose to be injected is not to exceed 25 mL The ureteral orifices urine jet will be observed and a video will be recorded for 10 minutes The time that will be captured on video is from the time of Bludigo injection to 10 minutes post injection If both ureters cannot be visualized simultaneously then alternating 15-30 second images of each ureter or ureteral orifice will be obtained The surgeon should note the time blue color is visualized in each ureter jet stream
Blood samples for PK analysis Urine samples will be collected at 0-30 minutes and 30 minutes- 2 hours post Bludigo injection
All treated patients will have a follow-up visit 14 3 days after the procedure A final telephone call to assess adverse events AEs will occur at Day 30 2 days
Safety assessments will include monitoring of vital signs AEs and laboratory testing post the procedure
The study will enroll approximately 18 pediatric patients from approximately 2-3 study centers in the United States
Patients scheduled for urological or gynecological surgical procedures who are 17 years will be screened for participation
A minimum of 6 patients will be enrolled in each of the following three age groups birth to 6-years old 6 to 12 years old 12 to 17 years old
Screening will occur within 30 days before study drug administration Day of Surgery
After signing the informed consent review of inclusion and exclusion criteria will be performed The collection of medical history and concomitant medications the completion of a physical examination including vital signs measurement ECG and the collection of baseline laboratory testing samples must be collected within 14 days of day 1 will be completed during the screening period
On the Day of Surgery Day 1 patients will be evaluated for eligibility for treatment
To evaluate the efficacy outcomes each patient will be injected with a weight-based dose of Bludigo 005 mLkg rounded up if necessary to a minimum of 05 mL the maximum dose to be injected is not to exceed 25 mL The ureteral orifices urine jet will be observed and a video will be recorded for 10 minutes The time that will be captured on video is from the time of Bludigo injection to 10 minutes post injection If both ureters cannot be visualized simultaneously then alternating 15-30 second images of each ureter or ureteral orifice will be obtained The surgeon should note the time blue color is visualized in each ureter jet stream
Blood samples for PK analysis Urine samples will be collected at 0-30 minutes and 30 minutes- 2 hours post Bludigo injection
All treated patients will have a follow-up visit 14 3 days after the procedure A final telephone call to assess adverse events AEs will occur at Day 30 2 days
Safety assessments will include monitoring of vital signs AEs and laboratory testing post the procedure
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
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?:
None