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Endomicroscopy

Non-Sedative Endomicroscopy for Healthy Infants

N/A

Waitlist Available

Led By Guillermo Tearney, MD, PhD

Research Sponsored by Massachusetts General Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

6 to 48 month old infants that can follow fasting requirements

Be younger than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up approximate 90 minute study visit

Awards & highlights

Study Summary

This trial aims to use a new device to examine the gut of infants with no need for sedation.

Who is the study for?

This trial is for healthy infants aged between 6 to 48 months who can follow fasting requirements before the procedure. It's designed to test a new way of looking at their intestines without sedation.Check my eligibility

What is being tested?

The study is testing the use of transnasal endomicroscopy (TNE) in unsedated infants. This involves using a tiny tube through the nose to view and evaluate the intestine, measure its potential difference, and collect microbiome samples.See study design

What are the potential side effects?

Potential side effects may include discomfort due to the introduction tube, nasal irritation, gagging or choking sensation during TNE procedure. However, serious side effects are not expected in this study.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximate 90 minute study visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximate 90 minute study visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximate 90 minute study visit for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Ability for unsedated infant subjects to tolerate the device

Ability to acquire gastrointestinal images in an unsedated infant

Ability to acquire microbiome brush and intestinal potential difference samples

+1 more

Secondary outcome measures

Ability to collect intestinal potential difference measurements in various locations in the gastrointestinal tract of unsedated infants

Amount and composition of microbial samples acquired via microbiome brush sampling in unsedated infants

Trial Design

1Treatment groups

Experimental Treatment

Group I: Trans Nasal Endomicroscopy ImagingExperimental Treatment1 Intervention

The subject will have the transnasal introduction tube inserted, and OCT images will be acquired using the OCT compact imaging system. The subject may also undergo a microbiome brushing and/or intestinal potential difference measurement procedure during the study visit.

0 / 1Eligibility criteria met

Find a Location

Who is running the clinical trial?

Bill and Melinda Gates FoundationOTHER

407 Previous Clinical Trials

22,924,073 Total Patients Enrolled

Massachusetts General HospitalLead Sponsor

2,928 Previous Clinical Trials

13,198,340 Total Patients Enrolled

Guillermo Tearney, MD, PhDPrincipal InvestigatorMassachusetts General Hospital

8 Previous Clinical Trials

1,140 Total Patients Enrolled

Media Library

Transnasal introduction tube (Endomicroscopy) Clinical Trial Eligibility Overview. Trial Name: NCT05857488 — N/A

Healthy Subjects Clinical Trial 2023: Transnasal introduction tube Highlights & Side Effects. Trial Name: NCT05857488 — N/A

Healthy Subjects Research Study Groups: Trans Nasal Endomicroscopy Imaging

Transnasal introduction tube (Endomicroscopy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05857488 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical trial permit the participation of individuals under thirty years old?

"This medical study seeks participants between 6 and 48 months old."

Answered by AI

Do I meet the prerequisites to join this trial?

"To be accepted into this medical trial, potential participants must present as healthy and fall within the age range of 6 months to 48 months. A total of 15 persons are needed for full participation in the research effort."

Answered by AI

Has recruitment opened for this clinical experiment?

"Based on the information provided by clinicaltrials.gov, this medical research has ceased recruitment of study participants; it was initially posted on January 1st 2022 and last updated May 4th 2023. Despite these circumstances, 815 other trials are seeking out patients for participation currently."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at University of Virginia (UVa)

Guillermo Tearney 2022. "Feasibility, Safety and Utility of Endomicroscopy to Study the Intestines of Unsedated Infants at University of Virginia (UVa)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05857488.