Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The goal of this clinical trial is to learn if Lumitrace and the KARL STORZ POWER LED BLUE System can be used for anatomic visualization of the ureters in participants undergoing laparoscopic abdominopelvic surgery.
The main questions it aims to answer are:
Participants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace.
Up to 10 participants will be enrolled and will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales.
A safety follow-up visit will occur within 14 ±7 days of Lumitrace administration.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 130 mg Lumitrace | Experimental | Participants will receive a single intravenous 130 mg dose of Lumitrace. Within 30 minutes of injection, the ureter visualization will be captured by the KARL STORZ POWER LED BLUE System using white light and fluorescence and the surgeon will rate ureter visualization for each illumination mode based on qualitative Likert Scales. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lumitrace | Drug | Administered as a bolus intravenous injection over 30 - 60 seconds |
|
| Measure | Description | Time Frame |
|---|---|---|
| Intra-participant difference in laparoscopic view of ureter conspicuity for white light (WL) versus fluorescence (BLUE) | Imaging will be acquired within 30 minutes post Lumitrace administration. Images from one or both ureters may be evaluated for anatomical visualization. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on the Likert Scales as follows. White light visibility will be measured using a 4-point scale where 0 represents not visible and 3 represents excellent visibility. For images collected using the BLUE setting, intensity will be graded based on the following: (0 = none; 1 = mild; 2 = moderate; and 3 = strong). | Day of surgery |
Not provided
Not provided
Inclusion Criteria:
Age > 18 years - male or female
Participants who are capable of directly providing informed consent and who can comply with the requirements and restrictions required by the protocol
Participant is scheduled to undergo minimally invasive laparoscopic abdominopelvic surgery that may require ureter(s) identification
eGFR≥60 mL/min/1.73m2
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Richard B Doshow, PhD | Contact | 314-735-0967 | rbdorshow@medibeacon.com |
| Name | Affiliation | Role |
|---|---|---|
| Richard B Dorshow, PhD | MediBeacon, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Missouri, Kansas, City, School of Medicine; Division of Urogynecology and Reconstructive Pelvic Surgery, | Recruiting | Kansas City | Missouri | 64108 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| C000657342 | relmapirazin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| KARL STORZ POWER LED BLUE System | Device | Imaging will be acquired within 30 minutes post Lumitrace administration. Following the initial endoscopic surgical incision, the surgeon will record the image assessments based on Likert Scales. |
|