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OCT-Guided Trans Nasal Imaging for Environmental Enteric Dysfunction

N/A

Recruiting

Led By Guillermo Tearney, M.D, 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

Subjects who are in their 2nd trimester of pregnancy

Subject must be able to consent to the procedure

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

Study Summary

This trial is testing a new imaging device that could improve diagnostics for gastrointestinal diseases.

Who is the study for?

This study is looking for healthy adults aged 18-60 and pregnant women in their second trimester, without high-risk conditions or diabetes on medication. Participants must be able to consent and fast before the procedure. Those with nasal, gastrointestinal, or clotting issues, or using certain medications are excluded.Check my eligibility

What is being tested?

The trial is testing a new TNIB Catheter imaging device developed by the Tearney Laboratory to enhance diagnosis of gastrointestinal diseases. It involves trans nasal imaging of the small intestine using this novel catheter.See study design

What are the potential side effects?

Potential side effects may include discomfort from fasting and having an NJ tube placed through the nose into the small intestine. There might also be risks associated with sedation if used during the procedure.

Eligibility Criteria

Inclusion Criteria

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

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I am in my second trimester of pregnancy.

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I can understand and agree to the treatment plan.

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I am between 18 and 60 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months 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 subject to tolerate the device

Ability to visualize gastrointestinal features

Trial Design

1Treatment groups

Experimental Treatment

Group I: Feasibility of TNIB catheterExperimental Treatment1 Intervention

The feasibility of using the TNIB catheter to obtain microscopic images of the intestine. Healthy adult volunteers, and healthy pregnant women in their 2nd trimester of pregnancy will be enrolled, and their upper gastrointestinal tract will be imaged by the TNIB device

0 / 3Eligibility criteria met

Find a Location

Who is running the clinical trial?

Massachusetts General HospitalLead Sponsor

2,933 Previous Clinical Trials

13,198,471 Total Patients Enrolled

Bill and Melinda Gates FoundationOTHER

407 Previous Clinical Trials

22,924,058 Total Patients Enrolled

Guillermo Tearney, M.D, PhD.Principal Investigator - Massachusetts General Hospital

Massachusetts General Hospital

6 Previous Clinical Trials

610 Total Patients Enrolled

Media Library

TNIB Catheter Clinical Trial Eligibility Overview. Trial Name: NCT04984447 — N/A

Environmental Enteric Dysfunction Research Study Groups: Feasibility of TNIB catheter

Environmental Enteric Dysfunction Clinical Trial 2023: TNIB Catheter Highlights & Side Effects. Trial Name: NCT04984447 — N/A

TNIB Catheter 2023 Treatment Timeline for Medical Study. Trial Name: NCT04984447 — N/A

Frequently Asked Questions

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

Is it possible to enroll in this medical experiment at present?

"Indeed, the information posted on clinicaltrials.gov indicates that this study is actively seeking participants. It was initially advertised in September 2017 and has been renewed as recently as July 2021. The trial requires 30 subjects to be enrolled from a single site."

Answered by AI

Do I meet the criteria to enroll in this clinical trial?

"This medical trial is recruiting 30 participants suffering from environmental enteric dysfunction (EED) aged between 18 and 60. To be eligible, candidates must adhere to the following prerequisites: an 8-hour fast with no liquid intake 2 hours prior to testing, as well as being outside of their second trimester pregnancy window while possessing the capacity for informed consent."

Answered by AI

Is the enrollment criteria for this trial limited to adults aged 18 and older?

"The eligibility requirements for this particular clinical trial stipulate that participants must be between 18 to 60 years of age. For those under or over the specified range, an alternate study is available."

Answered by AI

How many participants are being enrolled in this medical experiment?

"Affirmative. Clinicaltrials.gov displays that recruitment is ongoing for this clinical trial, which was first made public on September 22nd 2017 and most recently modified on July 21st 2021. The study seeks to enlist 30 individuals at 1 site."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

Guillermo Tearney 2017. "OCT Guided Trans Nasal Imaging of the Small Intestine in Adults". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04984447.