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OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

NCT04984447 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-10-22

No results posted yet for this study

Summary

The investigators are seeking healthy adult participants 18-60 years and healthy pregnant women in their 2nd trimester of pregnancy for a research study to assess a new imaging device. The Tearney Laboratory at the Wellman Center for Photomedicine at Massachusetts General Hospital is developing high-resolution imaging devices that can be used to improve diagnostics in gastrointestinal diseases.

Conditions

  • Environmental Enteric Dysfunction

Interventions

DEVICE

TNIB Catheter

Pariticipants will be asked to fast for 8 hours prior to study procedure and no liquids 2 hours prior to study procedure. Lidocaine jelly will may be used to help insert the TNIB Catheter through the Nares. Once inserted past the pharynx, imaging will begin. We will attempt to image the duodenum within 3 hours of study procedure starting.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

  • Guillermo Tearney, M.D, PhD. · Massachusetts General Hospital

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-09-22
Primary Completion
2027-12-31
Completion
2029-12-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04984447 on ClinicalTrials.gov