Evaluation of Lumitrace for Visualizing Ureters During Abdominopelvic Surgeries
ConditionUreter Injury
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorMediBeacon
About this trial
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.
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.
Eligibility criteria
Qualifiers
Age > 18 years - male or female
Eligible female non-pregnant subjects 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 the time of consent through 30 days after Lumitrace administration; i.e. abstinence, oral contraceptive either combined or progesterone alone; injectable progesterone, implants of levonorgestrel, estrogenic vaginal ring, percutaneous contraceptive patches, IUD device or system, or male partner sterilization
Disqualifiers
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 risk, or compromise the interpretability of study results, which makes the participant unsuitable for study participation
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
Trial design
Treatments tested in this trial
- Lumitrace
- KARL STORZ POWER LED BLUE System
Treatment groups
10 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov