Trials / Completed
CompletedNCT02209532
A Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping
A Randomized, Prospective, Open Label, Multicenter Study Assessing the Safety and Utility of PINPOINT® Near Infrared Fluorescence Imaging in the Identification of Lymph Nodes in Patients With Uterine and Cervical Malignancies Who Are Undergoing Lymph Node Mapping
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Novadaq Technologies ULC, now a part of Stryker · Industry
- Sex
- Female
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This is a randomized, prospective, open label, multicenter study to assess the safety and utility of PINPOINT® Near Infrared Fluorescence Imaging (PINPOINT) in identification of lymph nodes (LN) in patients with uterine and cervical malignancies who are undergoing LN mapping.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | PINPOINT | PINPOINT® Near Infrared Fluorescence Imaging to identify lymph nodes |
Timeline
- Start date
- 2015-12-01
- Primary completion
- 2017-06-01
- Completion
- 2017-06-01
- First posted
- 2014-08-06
- Last updated
- 2019-03-25
- Results posted
- 2019-03-25
Locations
8 sites across 3 countries: United States, Canada, Puerto Rico
Source: ClinicalTrials.gov record NCT02209532. Inclusion in this directory is not an endorsement.