OCT-Guided Trans Nasal Imaging for Environmental Enteric Dysfunction

Overseen ByAnita Chung, RN

Age: 18 - 65

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Must not be taking: Anticoagulants, Antiplatelets, NSAIDs, Steroids

Disqualifiers: Upper respiratory disease, Upper GI surgery, High-risk pregnancy, Diabetes, others

No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

The investigators are seeking healthy adult volunteers 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.

Do I need to stop taking my current medications to join the trial?

Yes, you may need to stop taking certain medications. The trial excludes people on medications that delay stomach emptying, drugs that affect blood clotting, and nasal or allergy steroids.

What data supports the effectiveness of the TNIB Catheter treatment for Environmental Enteric Dysfunction?

The research shows that Optical Coherence Tomography (OCT), which is part of the TNIB Catheter treatment, is effective in providing high-resolution images of tissues, helping to detect and monitor diseases in the gastrointestinal tract. This suggests that the TNIB Catheter could be useful in diagnosing and monitoring conditions like Environmental Enteric Dysfunction.¹ ² ³ ⁴ ⁵

Is OCT-guided trans nasal imaging safe for humans?

Optical coherence tomography (OCT) is generally considered safe as it is a non-invasive imaging technique that uses light to create detailed images of tissues. Studies have used OCT in various parts of the body, including the gastrointestinal tract and sinonasal mucosa, without significant safety concerns reported.¹ ² ⁵ ⁶ ⁷

How does OCT-guided trans nasal imaging differ from other treatments for environmental enteric dysfunction?

OCT-guided trans nasal imaging is unique because it uses a noninvasive imaging technique called optical coherence tomography (OCT) to produce detailed images of tissues, which can help in diagnosing and monitoring conditions. Unlike traditional treatments that may rely on more invasive methods, this approach offers a way to visualize and assess the condition without surgery or biopsies.¹ ² ³ ⁵ ⁷

Research Team

Guillermo Tearney, M.D, PhD.

Principal Investigator

Massachusetts General Hospital

Eligibility Criteria

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.

Inclusion Criteria

I am in my second trimester of pregnancy.

Healthy subjects

Subject must fast (no solid food) for at least 8 hours and have no liquids within 2 hours prior to the procedure

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Exclusion Criteria

I have had surgery on my upper stomach or intestines.

I am pregnant with diabetes and need medication to manage it.

Pregnant women with high-risk pregnancies such as history of hyperemesis gravidarum, HIV, severe anemia or any other high-risk pregnancy conditions at the discretion of the subject's physician and the PI

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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Imaging Procedure

Participants undergo imaging of the upper gastrointestinal tract using the TNIB device

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after the imaging procedure

6 months

Treatment Details

Interventions

TNIB Catheter

Trial OverviewThe 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.

Participant Groups

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