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NCT03502798 · ClinicalTrials.gov registry record · NA
Coherence Imaging of the Cervical Epithelium With Scanning a/LCI
A NA study of Cervical Dysplasia, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 45
- Enrollment target
- 2
- Study locations
NCT03502798: Completed NA study of Cervical Dysplasia, sponsored by Duke University.
NCT03502798 is a NA study of Cervical Dysplasia that has completed, run by Duke University. The registered enrollment target is 45 participants, below the 543-participant average among 7 other Cervical Dysplasia trials with a reported enrollment target (92% lower). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03502798, a NA study of Cervical Dysplasia, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 45 participants
- Enrollment target
- 2
- Study locations
Study Summary
The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine: 1. the difference between two different types of cervical cells: ectocervical cells and endocervical cells. Cervical dysplasia is most likely to occur at the junction between these two types of cells. 2. features of individual cervical cells that indicate whether the cell is normal or abnormal (cervical dysplasia).
Primary Outcome
Sensitivity of the scanning a/LCI probe's ability to detect cervical dysplasia determined by calculating the percentage of correctly identified positive optical biopsies measured by the scanning a/LCI probe when compared to the gold standard, histopathology. There are two dichotomies of classification used in this study: one that focuses on the morphological differences between cells (histology-based classification), and one that focuses on the urgency of corresponding treatment (response-based
Conditions Studied
Interventions
- DEVICE scanning a/LCI
Study Locations (2)
New York
- Jacobi Medical Center - The Bronx
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 45 participants |
| Start Date | 2018-11-08 |
| Est. Completion | 2020-02-14 |
| Phase | NA |
What the finished NCT03502798 record still lists
NCT03502798 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 45 participants, a relatively small participant target, below the 543-participant average among 7 other Cervical Dysplasia trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Cervical Dysplasia appearing as the primary indexed condition, and to 1 intervention - of which scanning a/LCI is the first listed.
NCT03502798 reports a single indexed study location in New York, North Carolina.
Frequently Asked Questions
What is clinical trial NCT03502798 about?
NCT03502798 is a clinical study titled "Coherence Imaging of the Cervical Epithelium With Scanning a/LCI". The purpose of this study is to develop a low coherence interferometry (LCI) endoscopic probe that can examine the cervix for evidence of cervical dysplasia. The device will make optical measurements of the cervix to determine: 1. the difference between two different types of cervical cells: ectoce...
What is the current status of trial NCT03502798?
This trial is currently completed. It is a NA study. The enrollment target is 45 participants. The study started on 2018-11-08. Estimated completion is 2020-02-14.
What conditions does trial NCT03502798 study?
This clinical trial studies the following conditions: Cervical Dysplasia.
What interventions are being tested in trial NCT03502798?
The interventions under investigation include: scanning a/LCI (DEVICE).
Who is sponsoring clinical trial NCT03502798?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03502798 being conducted?
This trial has 2 study locations across New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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