Intraoperative Ureter Injury
Conditions
Keywords
contrast agent, intraoperative monitoring, intraoperative procedures, near infrared fluorescence, minimally invasive
Brief summary
Phase 2, multicenter, efficacy and safety study evaluating the use of nerindocianine for the delineation of abdominopelvic ureter anatomy via near infrared fluorescence imaging during minimally invasive lower abdominal surgery (e.g. gynecological, lower gastrointestinal, or other lower abdominal surgery).
Detailed description
The primary objective of this study is to assess the acceptance of near-infrared (NIR) fluorescence imaging (650 to 900 nm) compared to white light (WL) using 3 3-point Likert scales.
Interventions
Procedure: routine minimally invasive abdominopelvic surgery.
Sponsors
Li-Cor, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Provide written informed consent prior to the initiation of study procedures. * At least 18 years of age. * Consent to undergo minimally invasive, lower pelvic surgery.
Exclusion criteria
* Unwilling or unable to provide informed consent. * Unwilling or unable to comply with the requirements of the protocol. * Females who are pregnant, lactating, or planning a pregnancy throughout the study. * Patients administered indocyanine green (ICG) at the same time of the lower pelvic surgery. * Have known allergies to D-mannitol and/or citric acid. * Participation in another clinical trial involving a drug in the past 12 weeks. * Any other condition that, in the investigator's judgment, would potentially compromise the study compliance or the ability to evaluate safety or efficacy of the investigational product, or determined not a safe candidate for surgery based on standard of care for current medical condition.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of ureter delineation using a Likert scale to measure ureter visualization | Surgical procedure duration, estimated up to 5 hours | Evaluation of the pelvic ureter under WL and NIR illumination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Treatment-Emergent Adverse Events | 30 +/- 5 days | Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events |
| Hourly time point scores concurrence with video review | Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours) | Three 3-pt Likert scale scores at hourly time points during the procedure. |
Countries
United States
Outcome results
None listed