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NCT04563754 · ClinicalTrials.gov registry record · Phase 1
The Effectiveness of High Resolution Microendoscopy for People Living With HIV
A Phase 1 study, sponsored by Baylor College of Medicine.
- Completed
- Registry status
- Phase 1
- Development phase
- 163
- Enrollment target
NCT04563754 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 163 participants.
The verdict
NCT04563754, a Phase 1 study, has completed, sponsored by Baylor College of Medicine.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 163 participants
- Enrollment target
Study Summary
The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated with neoplasia. The investigators' central hypothesis is that this 'optical' approach will increase the efficiency, clinical impact, and cost-effectiveness of the current standard of high-resolution anoscopy(HRA)-guided biopsy, thus facilitating usage by less-experienced clinicians in community-based or low-resource settings. To validate this, the investigators will conduct a study to determine the efficiency and diagnostic characteristics of the mHRME 'optical biopsy' approach versus the current standard of HRA-based tissue biopsy. Successful results will allow for improved efficacy and resource utilization for cancer screening in people living with HIV for anal cancer and other epithelial cancers including the cervix, oral cavity, bladder, and GI tract.
Interventions
- DRUG Proflavine Hemisulfate
- DIAGNOSTIC_TEST mHRME (Mobile High resolution microendoscope)
- DIAGNOSTIC_TEST High resolution anoscopy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 163 participants |
| Start Date | 2019-07-30 |
| Est. Completion | 2025-03-28 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04563754
The ClinicalTrials.gov registry entry for NCT04563754 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 163 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Baylor College of Medicine, which has 616 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Proflavine Hemisulfate is the first listed.
NCT04563754 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04563754 about?
NCT04563754 is a clinical study titled "The Effectiveness of High Resolution Microendoscopy for People Living With HIV". The investigators have developed a portable, battery-operated, mobile high-resolution microendoscope (mHRME) that provides subcellular images of the anal epithelium, delineating the cellular and morphologic changes associated with neoplasia. The investigators' central hypothesis is that this 'optica...
What is the current status of trial NCT04563754?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 163 participants. The study started on 2019-07-30. Estimated completion is 2025-03-28.
What interventions are being tested in trial NCT04563754?
The interventions under investigation include: Proflavine Hemisulfate (DRUG), mHRME (Mobile High resolution microendoscope) (DIAGNOSTIC_TEST), High resolution anoscopy (DIAGNOSTIC_TEST).
Who is sponsoring clinical trial NCT04563754?
This trial is sponsored by Baylor College of Medicine, which has 616 total clinical trials registered on ClinicalTrials.gov.
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