OCT-Guided Trans Nasal Imaging for Environmental Enteric Dysfunction

Overseen By Anita 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 Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

30 Participants Needed

What You Need to Know Before You Apply

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.

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 3 4 5}

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. ^{2 3 4 5 6}

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. ^{2 3 5 6 7}

Who Is on the Research Team?

Guillermo Tearney, M.D, PhD.

Principal Investigator

Massachusetts General Hospital

Are You a Good Fit for This Trial?

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

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

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• TNIB Catheter

Trial Overview 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.

How Is the Trial Designed?

Group I: Feasibility of TNIB catheter Experimental Treatment 1 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

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Bill and Melinda Gates Foundation

Collaborator

Trials

428

Recruited

23,060,000+

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Optical Coherence Tomography as a Tool for Imaging the Sinonasal Mucosa in Patients: A Systematic Review. [2023]

2. United States pubmed.ncbi.nlm.nih.gov

Expanding Functionality of Commercial Optical Coherence Tomography Systems by Integrating a Custom Endoscope. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Methods and application areas of endoscopic optical coherence tomography. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Optical coherence tomography. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Ultrahigh speed endoscopic optical coherence tomography for gastroenterology. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

In vivo ultrahigh-resolution optical coherence tomography of mouse colon with an achromatized endoscope. [2019]

7. United States pubmed.ncbi.nlm.nih.gov

Endoscopically guided spectral-domain OCT with double-balloon catheters. [2021]