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COMPLETED Early Phase 1

Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer

NCT01384708 · View on ClinicalTrials.gov ↗

Study Summary

The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collaborators at Rice University and provides \> 1000x magnified images of the esophageal mucosa. The purpose of this study is to determine whether this device can be used to enhance the diagnostic accuracy of routine endoscopic screening for squamous cell cancer of the esophagus.

Conditions Studied

Interventions

  • DRUG proflavine

Study Locations (1)

New York

  • Mount Sinai Medical Center — New York

Trial Details

FieldValue
Enrollment Target 70 participants
Start Date 2010-08
Est. Completion 2013-10
Phase Early Phase 1

Sponsor

Anandasabapathy, Sharmila, M.D.

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT01384708

The ClinicalTrials.gov registry entry for NCT01384708 describes a study currently listed as completed. It is categorized as Early Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 70 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Anandasabapathy, Sharmila, M.D., which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Squamous Cell Cancer appearing as the primary indexed condition, and to 1 intervention — of which proflavine is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT01384708 reports 1 study location spanning 1 distinct geographic area — top geographies include New York. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT01384708 about?

NCT01384708 is a clinical study titled "Evaluation of a Miniaturized Microscope Device for the Detection of Esophageal Squamous Cell Cancer". The overall objective of this study is to determine whether high-resolution imaging of the esophagus during routine diagnostic upper endoscopy can assist clinicians in detecting and discriminating dysplastic (precancerous) areas. This high-resolution microendoscope (HRME) was developed by our collab...

What is the current status of trial NCT01384708?

This trial is currently completed. It is a Early Phase 1 study. The enrollment target is 70 participants. The study started on 2010-08. Estimated completion is 2013-10.

What conditions does trial NCT01384708 study?

This clinical trial studies the following conditions: Squamous Cell Cancer. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT01384708?

The interventions under investigation include: proflavine (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT01384708?

This trial is sponsored by Anandasabapathy, Sharmila, M.D., which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT01384708 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial