mHRME (Mobile High resolution microendoscope) for Anal Squamous Intraepithelial Lesions
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.
- Anal High-Grade Squamous Intraepithelial Lesions
1 Primary · 2 Secondary · Reporting Duration: Day 1
2 Treatment Groups
1 of 2
mHRME and HRA
1 of 2
200 Total Participants · 2 Treatment Groups
Primary Treatment: mHRME (Mobile High resolution microendoscope) · No Placebo Group · Phase 1 & 2
Participation is compensated
You will be compensated for participating in this trial.
Who is running the clinical trial?
Age 18+ · All Participants · 4 Total Inclusion CriteriaMark “Yes” if the following statements are true for you:
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
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor