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Clinical program has been suspended for business reasons.
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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerindocianine for injection | Experimental | One Arm: Nerindocianine for Injection (0.055 mg/kg body weight); solution, intravenous, one time administration during surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerindocianine for injection | Drug | Procedure: routine minimally invasive abdominopelvic surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of ureter delineation using a Likert scale to measure ureter visualization | Evaluation of the pelvic ureter under WL and NIR illumination | Surgical procedure duration, estimated up to 5 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events | 30 +/- 5 days |
| Hourly time point scores concurrence with video review |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Giovanna Da Silva Southwich, M.D. | Cleveland Clinic Florida | Principal Investigator |
| Jubilee Brown, M.D. | Carolinas Medical Center / Levine Cancer Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cleveland Clinic Florida | Weston | Florida | 33331 | United States | ||
| Carolinas Medical Center/Levine Cancer Institute |
There is no plan to make individual participant data (IPD) available.
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| ID | Term |
|---|---|
| D007267 | Injections |
| C000713247 | IRDye 800BK |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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Three 3-pt Likert scale scores at hourly time points during the procedure.
| Scoring occurs at 1-hour intervals for duration of surgical procedure (estimated duration from 1 to 5 hours) |
| Charlotte |
| North Carolina |
| 28204 |
| United States |