Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
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: Completed Phase 1 study, sponsored by Baylor College of Medicine.
NCT04563754 is a Phase 1 study that has completed, run by Baylor College of Medicine. The registered enrollment target is 163 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (172% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
The primary outcome of this study is to measure the operating characteristics including SN, SP, PPV and NPV comparing the physician- and algorithm- guided HRME-based image compared to the Lugol's- guided physician diagnosis of HSIL during HRA. Gold standard consensus pathology was used and pathology data needs to be obtained, verified, and entered.
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 |
What the finished NCT04563754 record still lists
NCT04563754 is an interventional study that assigns participants to a tested intervention. The registered 163 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (172% higher).
The record links to 0 conditions, and to 3 interventions - of which Proflavine Hemisulfate is the first listed.
NCT04563754 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04563754's enrollment target sits among peer trials
163 336th of 2000 higher than 1,665 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT03180268 · 163 participants · Phase 3
Observation or Radiation Therapy in Treating Patients With Newly Diagnosed Grade II Meningioma That Has Been Completely Removed by Surgery
- NCT04862221 · 163 participants · Phase 2
TReatment for ImmUne Mediated PathopHysiology
- NCT05702229 · 163 participants · Phase 2
Novel Combinations in Participants With Locally Advanced Unresectable or Metastatic Gastric or Gastroesophageal Junction Adenocarcinoma
- NCT06137118 · 163 participants · Phase 1
AZD0486 as Monotherapy in B-cell Acute Lymphoblastic Leukaemia
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI