Intraoperative Ureter Injury
Conditions
Keywords
contrast agent, ureter imaging, intraoperative monitoring, intraoperative procedures, near infrared fluorescence, minimally invasive
Brief summary
The purpose of this clinical trial is to study the safety and efficacy of an investigational imaging agent for delineation/visualization of urologic anatomy in the setting of minimally invasive surgery.
Interventions
Procedure: routine minimally invasive pelvic surgery.
Sponsors
Li-Cor, Inc.
Study design
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
beginning at the estimated target dose, the dosage was increased and decreased to confirm the near-optimal dose.
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent prior to the initiation of study procedures * Are \> 18 years of age * Women consented to undergo standard of care minimally invasive pelvic surgery (traditional laparoscopy and robotic surgery) * Women who are expected to be admitted to the hospital following surgery for at least 24 hours
Exclusion criteria
* Are unwilling or unable to provide informed consent. * Are unwilling or unable to comply with the requirements of the protocol. * History of prior urologic surgery. * History of prior pelvic surgery. * History of known retroperitoneal fibrosis. * Have any of the following screening laboratory values: * Hemoglobin ≤ 8.0 g/dL; * Absolute neutrophil count (ANC) ≤ 1500/μL; * Platelet count ≤ 100,000/μL; * Serum creatinine ≥ 1.5 x the institutional upper limit of normal (IULN) creatinine; * Serum bilirubin ≥ 1.5 x IULN; * Aspartate transaminase (AST or serum glutamic oxaloacetic transaminase, SGOT) ≥ 2x IULN;• Alanine transaminase (ALT or serum glutamate pyruvate transaminase, SGPT) ≥ 2 x IULN. * Females who are pregnant, lactating, or breastfeeding; * Any other condition that, in the Investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events | 30 days | Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events |
| Dose response | 10 minutes through 90 minutes post administration | Dose response based on the composite assessment of the anatomy and laterality for detection of pelvic ureter in women undergoing minimally invasive surgery |
Countries
United States
Outcome results
None listed