mHRME (Mobile High resolution microendoscope) for Anal Squamous Intraepithelial Lesions

Phase-Based Progress Estimates
M.D. Anderson Cancer Center, Houston, TXAnal Squamous Intraepithelial LesionsmHRME (Mobile High resolution microendoscope) - DiagnosticTest
All Sexes
What conditions do you have?

Study Summary

This trial is testing a new, portable microendoscope that takes subcellular images of the anal epithelium to look for changes associated with neoplasia (abnormal tissue growth). The investigators hypothesis is that this 'optical' approach will be more efficient and have a greater clinical impact than the standard of HRA (High resolution anoscopy)-guided biopsy.

Eligible Conditions
  • Anal High-Grade Squamous Intraepithelial Lesions

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 2 Secondary · Reporting Duration: Day 1

Day 1
Performance characteristics: Sensitivity (SN), Specificity (SP), positive predictive value (PPV) and negative predictive values (NPV)
Procedure efficiency
Procedure time

Trial Safety

Trial Design

2 Treatment Groups

1 of 2
1 of 2

Experimental Treatment

200 Total Participants · 2 Treatment Groups

Primary Treatment: mHRME (Mobile High resolution microendoscope) · No Placebo Group · Phase 1 & 2

mHRMEExperimental Group · 3 Interventions: High resolution anoscopy, Proflavine Hemisulfate, mHRME (Mobile High resolution microendoscope) · Intervention Types: DiagnosticTest, Drug, DiagnosticTest
Experimental Group · 1 Intervention: mHRME (Mobile High resolution microendoscope) · Intervention Types: DiagnosticTest
First Studied
Drug Approval Stage
How many patients have taken this drug
Proflavine Hemisulfate
Completed Early Phase 1

Trial Logistics


Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: day 1

Who is running the clinical trial?

Medical University of South CarolinaOTHER
855 Previous Clinical Trials
5,390,001 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
2,827 Previous Clinical Trials
1,792,468 Total Patients Enrolled
The University of Texas Health Science Center, HoustonOTHER
821 Previous Clinical Trials
259,704 Total Patients Enrolled
William Marsh Rice UniversityOTHER
40 Previous Clinical Trials
26,601 Total Patients Enrolled
University of California, San FranciscoOTHER
2,314 Previous Clinical Trials
11,758,198 Total Patients Enrolled
Baylor College of MedicineLead Sponsor
932 Previous Clinical Trials
5,989,155 Total Patients Enrolled
Icahn School of Medicine at Mount SinaiOTHER
791 Previous Clinical Trials
508,784 Total Patients Enrolled
Sharmilla Anandasabapathy, MDPrincipal InvestigatorBaylor College of Medicine
Elizabeth Y Chiao, MDPrincipal InvestigatorM.D. Anderson Cancer Center

Eligibility Criteria

Age 18+ · All Participants · 4 Total Inclusion Criteria

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Frequently Asked Questions

Does the FDA recognize mHRME as a safe and effective medical device?

"The safety of mHRME was given a 2. This is due to the fact that, while there are Phase 2 trials underway testing its safety, there are no such studies investigating whether or not the mobile high resolution microendoscope is effective." - Anonymous Online Contributor

Unverified Answer

Is this research project still recruiting individuals?

"That is correct. The information available on indicates that this study, which was originally posted on 7/1/2019, is still recruiting patients. They are looking for 200 individuals from 2 separate locations." - Anonymous Online Contributor

Unverified Answer

How many people are allowed to be in this trial at any given time?

"That is correct. The clinical trial in question, as reflected on the website, appears to be currently recruiting patients. This specific study was first published on 7/1/2019 and was most recently updated on 9/7/2021. They are looking for 200 volunteers at 2 different locations." - Anonymous Online Contributor

Unverified Answer
Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.