Dose-escalation Study of a Contrast Agent for Delineation of Urological Anatomy in Minimally Invasive Surgery

Completed · Phase 1/Phase 2

Conditions studied: Intraoperative Ureter Injury

In brief

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.

Key facts

Study ID

NCT03106038

Run by

Li-Cor, Inc.

People needed

41

Starts

2017-04-26

Expected to finish

2018-11-19

Last updated by the study team

2019-11-26

Who can join

Age: 19 and older. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• UAB Women & Infants Center — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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