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NCT02810236 · ClinicalTrials.gov registry record · NA
Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?
A NA study of Anxiety and Breast Diseases, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT02810236 is a NA study of Anxiety and Breast Diseases that has completed, run by Duke University. The registered enrollment target is 12 participants, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (97% lower). The trial reports 1 study location across 1 state.
The verdict
NCT02810236, a NA study of Anxiety and Breast Diseases, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The investigator hypothesizes that a benign directed ultrasound, when performed after a normal digital mammogram, will provide women with focal breast pain additional reassurance that the etiology of their symptom is benign. 160 women over the age of thirty with focal breast pain who present to the Breast Imaging Clinic for evaluation between 3/1/2016 - 7/1/2018 will be selected and randomized to three groups using a block randomization technique. All study participants will complete a survey assessing psychosocial factors, then receive a digital mammogram. Patients with a negative mammogram will continue on with the study and will either have a conversation about their negative mammogram with a radiologist or receive a directed ultrasound. A second survey will be conducted assessing psychosocial factors. All study participants who did not receive an ultrasound will receive an ultrasound so that all study participants are provided with the standard of care for focal breast pain. The results of the survey will be compared and appropriate statistical analyses such as an Analysis of Variance (ANOVA) test will be conducted to determine any statistically significant differences between the three randomized groups. The risks/safety issues of this study are believed to be minimal.
Conditions Studied
Interventions
- BEHAVIORAL Discussion
- PROCEDURE Ultrasound
Study Locations (1)
North Carolina
- Duke University Medical Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2018-02-01 |
| Est. Completion | 2019-11-30 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02810236
The ClinicalTrials.gov registry entry for NCT02810236 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 440-participant average among 364 other Anxiety trials with a reported enrollment target (97% lower). The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Anxiety appearing as the primary indexed condition, and to 2 interventions - of which Discussion is the first listed.
NCT02810236 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.
Frequently Asked Questions
What is clinical trial NCT02810236 about?
NCT02810236 is a clinical study titled "Focal Breast Pain: Does a Normal Ultrasound Provide Reassurance?". The investigator hypothesizes that a benign directed ultrasound, when performed after a normal digital mammogram, will provide women with focal breast pain additional reassurance that the etiology of their symptom is benign. 160 women over the age of thirty with focal breast pain who present to the ...
What is the current status of trial NCT02810236?
This trial is currently completed. It is a NA study. The enrollment target is 12 participants. The study started on 2018-02-01. Estimated completion is 2019-11-30.
What conditions does trial NCT02810236 study?
This clinical trial studies the following conditions: Anxiety, Breast Diseases, Mastodynia.
What interventions are being tested in trial NCT02810236?
The interventions under investigation include: Discussion (BEHAVIORAL), Ultrasound (PROCEDURE).
Who is sponsoring clinical trial NCT02810236?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02810236 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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