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

Phase 1 & 2

Waitlist Available

Led By Sharmilla Anandasabapathy, MD

Research Sponsored by Baylor College of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1

Awards & highlights

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.

Who is the study for?

This trial is for adults over 18 with HIV who have had abnormal anal cytology or documented HSIL in the past two years. They must be patients at specific clinics and able to consent. Excluded are those allergic to Proflavine or Iodine, with bleeding disorders, a history of invasive anal cancer, pregnant women, or those unable to undergo anoscopy.Check my eligibility

What is being tested?

The study tests a new portable device (mHRME) against standard high-resolution anoscopy (HRA) for detecting precancerous changes in the anus. The mHRME provides detailed images and aims to improve screening efficiency and accessibility for people living with HIV.See study design

What are the potential side effects?

Potential side effects may include reactions to the fluorescent contrast agent Proflavine used during imaging such as local irritation or allergic reaction. There's also a general risk associated with biopsies like bleeding or infection.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Performance characteristics: Sensitivity (SN), Specificity (SP), positive predictive value (PPV) and negative predictive values (NPV)

Secondary outcome measures

Procedure efficiency

Procedure time

Trial Design

1Treatment groups

Experimental Treatment

Group I: mHRMEExperimental Treatment3 Interventions

5-10 ml of proflavine hemisulfate (0.01%) will be applied on the anal epithelium. The mHRME will then be inserted and imaging of abnormal tissues will be performed. This is a single-arm study where all subjects will receive both standard of care HRA (High resolution anoscopy) and experimental mHRME imaging.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Proflavine Hemisulfate

2009

Completed Early Phase 1

~40

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

William Marsh Rice UniversityOTHER

45 Previous Clinical Trials

27,692 Total Patients Enrolled

M.D. Anderson Cancer CenterOTHER

2,976 Previous Clinical Trials

1,789,347 Total Patients Enrolled

University of California, San FranciscoOTHER

2,510 Previous Clinical Trials

15,243,546 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

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."

Answered by AI

Is this research project still recruiting individuals?

"That is correct. The information available on clinicaltrials.gov 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."

Answered by AI

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 clinicaltrials.gov, 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."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

The Effectiveness of High Resolution Microendoscopy for People Living With HIV

Sharmila Anandasabapathy 2019. "The Effectiveness of High Resolution Microendoscopy for People Living With HIV". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04563754.