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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nerindocianine for Injection | Experimental | One Arm: Nerindocianine for Injection (Initial dosing cohort: 0.06 mg/kg body weight); solution, intravenous, one time administration during surgery. the study has only one arm. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nerindocianine for Injection | Drug | Procedure: routine minimally invasive pelvic surgery. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Treatment-Emergent Adverse Events | Incidence of Treatment-Emergent Serious Adverse Events and/or Treatment-Emergent Adverse Events | 30 days |
| Dose response | Dose response based on the composite assessment of the anatomy and laterality for detection of pelvic ureter in women undergoing minimally invasive surgery | 10 minutes through 90 minutes post administration |
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Inclusion Criteria:
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:
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.
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| Name | Affiliation | Role |
|---|---|---|
| Kenneth H. Kim, M.D. | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| UAB Women & Infants Center | Birmingham | Alabama | 35233 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32615331 | Derived | Huh WK, Johnson JL, Elliott E, Boone JD, Leath CA 3rd, Kovar JL, Kim KH. Fluorescence Imaging of the Ureter in Minimally Invasive Pelvic Surgery. J Minim Invasive Gynecol. 2021 Feb;28(2):332-341.e14. doi: 10.1016/j.jmig.2020.06.022. Epub 2020 Jun 29. |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 26, 2021 | Sep 23, 2021 | 7 |
| ID | Term |
|---|---|
| D007267 | Injections |
| C000713247 | IRDye 800BK |
| ID | Term |
|---|---|
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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beginning at the estimated target dose, the dosage was increased and decreased to confirm the near-optimal dose.
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