Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT05396781 |
| Other study ID # |
H-44015 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 13, 2022 |
| Est. completion date |
January 20, 2022 |
Study information
| Verified date |
June 2022 |
| Source |
Anandasabapathy, Sharmila, M.D. |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
The investigators have a current trial in China and the US which provides significant support
for the safety, cost-effectiveness, accuracy and efficiency of a high resolution
microendoscope (HRME)-guided approach in the hands of experienced clinicians. To improve
functionality, portability and broader use of this device by non-experts, the investigators
recently developed a prototype marHRME platform with an automated, augmented reality
(AR)-interpretation that provides an overlaid endoscopic + micro-endoscopic view,
facilitating diagnosis and biopsy targeting.
Description:
The investigators' hypothesis is that this mobile device with automated, AR optical biopsy
diagnoses can efficiently and accurately facilitate endoscopic cancer detection in low to
middle income countries (LMICs) with less experienced providers and is acceptable to
providers and patients.
Objective 1: The investigators' first objective is to evaluate the marHRME technology in
terms of performance, efficiency, and impact. In a single-arm, feasibility study (n=50) of
high-risk subjects undergoing Lugol's chromoendoscopy (LCE) followed by marHRME for
esophageal squamous cell neoplasia (ESCN) screening, the investigators will evaluate the
diagnostic performance and efficiency of this automated optical biopsy device.
The investigators' main hypothesis is that the marHRME will:
1. increase the accuracy of Lugol's endoscopy (LCE), other exploratory hypotheses are
2. increase the accuracy of marHRME among novices and be non-inferior to experts,
3. increase user confidence among experts and novices and, subsequently,
4. increase the efficiency and impact of LCE by reducing biopsies and second procedures.
For performance for marHRME vs. Standard of Care, the investigators will compare the accuracy
of the marHRME + LCE vs. LCE alone to the gold-standard histopathology (expert GI
pathologist). For performance of the Machine vs. Man, the investigators will compare accuracy
of the marHRME software read to novice and expert clinicians' subjective read to
gold-standard histopathology. For clinician confidence and clinical impact, the investigators
will determine the clinician's confidence level in the software diagnosis and the potential
clinical impact of this diagnosis among novice and expert endoscopists using marHRME.
Objective 2: The investigators' secondary objective is to evaluate the acceptability of the
technology among patients and providers. All patients participating in the study will be
invited to participate in a brief (20 min) interviewer-administered survey prior to
undergoing endoscopy to assess attitudes and barriers to marHRME, and a follow-up interview
(7 days post-procedure) to determine experiences and acceptability. Informed consent and the
initial interview will be conducted in a private clinic room by trained study staff from the
Brazilian team using a brief Portuguese-language survey. The follow-up interview will occur
by phone, after a routine follow-up call by clinical staff.
The endoscopists and trainees participating in the feasibility study will be invited to
participate in a series of questionnaires and in- depth interviews administered at different
time points of the study to assess provider acceptance. Informed consent will be obtained
prior to the first interview. Clinicians will answer a brief questionnaire to assess
acceptance of marHRME prior to undergoing raining, after training, and after conducting 25
procedures. After 25 procedures, endoscopists and trainees will participate in a 30- minute
semi-structured interview to assess marHRME experience. The interviews will be audio
recorded, professionally transcribed, and translated (Portuguese to English) for coding and
analysis.
