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Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan

NCT04275167 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-01-14

No results posted yet for this study

Summary

This pilot study will test the feasibility and tolerability of the tethered OCT capsule and Trans Nasal Endomicroscopy probe and accessory devices for imaging the small intestine in subjects with EED and a matched non-EED cohort. This study will assess subject tolerability, optimal imaging technique, and imaging of EED features.

Conditions

  • Environmental Enteric Dysfunction

Interventions

DEVICE

Tethered Capsule Endomicroscope/Trans Nasal Endomicroscope

Either the Tethered Capsule Endomicroscope or the Transnasal Endomicroscope will be deployed in the subject. Once the capsule is swallowed /TNE device is inserted, the device will naturally be moved to the duodenum via peristalsis. Once in the duodenum, imaging will be performed. For subjects receiving the TNE device, brushing samples will be collected through the introduction tube.

Sponsors & Collaborators

  • Bill and Melinda Gates Foundation

    collaborator OTHER

  • Aga Khan University Hospital, Pakistan

    collaborator OTHER

  • Massachusetts General Hospital

    lead OTHER

Principal Investigators

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

Study Design

Allocation
NON_RANDOMIZED
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
6 Months
Max Age
70 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-10-11
Primary Completion
2028-01-31
Completion
2029-01-31
FDA Device
Yes

Countries

  • Pakistan

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 NCT04275167 on ClinicalTrials.gov