BridgeMD
New treatment option for Ureter Injury
Official title Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
ClinicalTrials.gov ID: NCT07080008
What this study is testing
What is Lumitrace?
Lumitrace is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ureter injury.
Also referred to as Relmapirazin, MB-102.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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: To evaluate the feasibility and clinical utility of Lumitrace to provide ureter visualization when used in tandem with the KARL STORZ POWER LED BLUE System during laparoscopic abdominopelvic surgery To evaluate the safety and tolerability of a single intravenous dose of Lumitrace in participants undergoing laparoscopic abdominopelvic surgery Participants will participate in a Screening visit that will take place within 28 days of the scheduled administration of Lumitrace.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older. Healthy volunteers may be eligible.
You may be able to join if
- Age \> 18 years - male or female
- Eligible female non-pregnant people who are either not of child-bearing potential or willing to use adequate contraception during the trial
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 30 days post-dose administration
- For women of child-bearing potential, the subject should have a negative serum pregnancy test on day of surgery, and agrees to one of the following...
- Men will not donate sperm during the study and for 30 days following the last dose of Lumitrace
You likely can't join if
- Participant has any serious or uncontrolled physical or psychiatric condition that in the opinion of the investigator would limit the their ability...
- Participant is anticipated to require ureteral stenting during surgery
- Participant has an active urinary tract infection requiring antibiotic therapy
- Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical...
- Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI
- Participant with body weight \< 30 kilogram (kg)
See the full eligibility criteria
- Age \> 18 years - male or female
- Eligible female non-pregnant people who are either not of child-bearing potential or willing to use adequate contraception during the trial
- Males must be willing to practice abstinence or utilize adequate contraception from dosing day to at least 30 days post-dose administration
- For women of child-bearing potential, the subject should have a negative serum pregnancy test on day of surgery, and agrees to one of the following acceptable contraceptive methods used consistently and correctly from...
- Men will not donate sperm during the study and for 30 days following the last dose of Lumitrace
- 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
- Participant has any serious or uncontrolled physical or psychiatric condition that in the opinion of the investigator would limit the their ability to complete study requirements or may put the subject at increased...
- Participant is anticipated to require ureteral stenting during surgery
- Participant has an active urinary tract infection requiring antibiotic therapy
- Participant has moderate to severe cardiac disease that limits daily functioning (New York Heart Association Class III to IV) or other medical conditions that would impact safety or study compliance
- Participant has any clinically relevant laboratory abnormality that could contraindicate surgery in the opinion of the PI
- Participant with body weight \< 30 kilogram (kg)
- History of severe allergic hypersensitivity reactions (unacceptable adverse events) or anaphylactoid reaction to any allergen including drugs, Lumitrace or other related products (intolerance to a drug is not considered...
- Participant has received any investigational therapy within 30 days or 5 half-lives, whichever is longer, prior to screening
- eGFR \<60 mL/min/1.73m2
- Participants with positive serum pregnancy test
The study team makes the final eligibility decision.
Where it's taking place
- Kansas City, Missouri, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Kansas City, Missouri, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.