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

NCT04275167 | Enrolling By Invitation FDA Device

• 1 other identifier: 2017P001219
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Tethered Capsule Endomicroscopy; Optical Coherence Tomography; EED; Pakistan; Intestinal Disorder

Outcome Measures

Primary Outcomes (1)

• Feasibility of TCE and TNE

  Number of participants that we have successfully deployed the Trans-nasal imaging device/Tethered capsule device in.

  up to 3 hours during the study.

Study Arms (2)

Feasibility of TCE

EXPERIMENTAL

Feasibility is measured by the number of participants that we have successfully deployed the Tethered capsule device in.

Device: Tethered Capsule Endomicroscope/Trans Nasal Endomicroscope

Feasibility of TNE and Microbiome Brushing

EXPERIMENTAL

Feasibility is measured by the number of participants that we have successfully deployed the TNE device and collected brush samples in.

Device: Tethered Capsule Endomicroscope/Trans Nasal Endomicroscope

Interventions

Tethered Capsule Endomicroscope/Trans Nasal Endomicroscope DEVICE

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.

Feasibility of TCE; Feasibility of TNE and Microbiome Brushing

Eligibility Criteria

• Age: 6 Months - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Children must be 6 months to 59 months old
• Adult participants 18 years of age or older scheduled for a standard of care endoscopy
• EED manifesting as malnourishment (WHZ\<-2) without clear etiology or healthy subjects with WHZ \>=0
• Participants and/or parents/guardians must be able to give informed consent/assent
• Participants and/or parents/guardians must be willing to provide consent for live streaming of the procedure
• Participants must be able to follow fasting instructions prior to the procedure
• Participants 18 years and older
• Participants who are in their 2nd trimester of singleton pregnancy as confirmed by an ultrasound
• Participants with a BMI below 18.5 without clear etiology and healthy pregnant women with BMI between 18.5 -24.5.
• Participants must be able to follow fasting instructions prior to the procedure
• Participants must be able to consent to the procedure

You may not qualify if:

• Participants with any history of esophageal or intestinal strictures or prior GI surgery
• Participants with history of pyloric stenosis
• Participants with HIV diagnosis
• Participants with any contraindications for NG/NJ tube placement, including but not limited to those listed below:
• Participants with any history of esophageal or intestinal strictures or prior GI surgery
• Participants with history of pyloric stenosis or atresia
• Participants with suspected or diagnosed HIV, Hepatitis B and C
• Participants with any history of esophageal or intestinal strictures or prior GI surgery
• Participants with a history of upper gastrointestinal surgery including fundoplication
• Participants with upper GI obstruction
• Participants with short bowel syndrome
• Participants with upper respiratory infection at least 7 days prior to the procedure
• Deviated septum or any other anatomical abnormalities of the nasopharynx or upper gastrointestinal region, history of trans-sphenoidal surgery, facial or cranial trauma and fractures, chronic sinusitis, esophageal strictures, varices etc.
• Participants on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
• Participants with upper GI bleeding

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bill and Melinda Gates Foundation: collaborator
• Aga Khan University Hospital, Pakistan: collaborator

Study Sites (1)

Aga Khan Medical Center

Karachi, Pakistan

Location

MeSH Terms

Conditions

Intestinal Diseases

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Guillermo Tearney, M.D, PhD.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guillermo J. Tearney, MD, PhD - Principal Investigator

Study Record Dates

• First Submitted: December 9, 2019
• First Posted: February 19, 2020
• Study Start: October 11, 2017
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 1, 2029
• Last Updated: January 14, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)