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OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

This study is testing a new imaging device called the TNIB Catheter. This device is a thin, flexible tube with a camera that goes through your nose to take high-resolution pictures of your small intestine (duodenum). Researchers want to see if healthy adults, aged 18-60, and healthy pregnant women in their second trimester can tolerate the device and if it can clearly show features of the digestive system. The goal is to develop better ways to diagnose stomach and bowel conditions. This study is currently recruiting participants.

Study design
This is an interventional study planning to enroll 30 healthy participants. It is not specified if it is randomized or blinded.
What's involved
You would need to fast for 8 hours and avoid liquids for 2 hours before the procedure. The TNIB Catheter will be inserted through your nose, and imaging will begin.
Compensation
Not stated in the trial record.
Follow-up
Your ability to tolerate the device will be checked at 3 hours. The ability to visualize gastrointestinal features will be assessed at 6 months.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04984447

OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

Enrolling by Invitation
NAAges 18–60InterventionalDevice feasibility
Massachusetts General Hospital
~30 participants
Updated 2025-10-22 on ClinicalTrials.gov
What's tested:TNIB Catheter

At a glance

Recruiting sites
0 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Ability for participant to tolerate the device
Measured over 3 hours
+1 more outcome measured

Conditions

Environmental Enteric Dysfunction

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Healthy Volunteers

NCT04984447

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Massachusetts General Hospital

    Boston, Massachusettsno site contact published

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Guillermo Tearney, M.D, PhD. · PRINCIPAL_INVESTIGATOR · Massachusetts General Hospital

Who to contact

This trial hasn't published a contact. View it on ClinicalTrials.gov

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Eligibility criteria

Inclusion

Healthy participants
Participants who are in their 2nd trimester of pregnancy
Participant must be 18-60 years of age
Participant must be able to consent to the procedure.
Participant must fast (no solid food) for at least 8 hours and have no liquids within 2 hours prior to the procedure.

Exclusion

Participants with a history of upper respiratory disease or surgery
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
Participants with a history of upper gastrointestinal surgery
Pregnant women with Type 1 diabetes
Pregnant women with Type 2 diabetes on medication and gestational diabetes requiring medication
Pregnant women with gestational thrombocytopenia
Participants with upper respiratory infection at least 7 days prior to the procedure
Pariticipants with any contraindications to the placement of the NJ tube including 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 medications that delay gastric emptying.
Participants on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
Participants using nasal steroids or any steroids for environmental allergies.

What this trial measures

  • Ability for participant to tolerate the device3 hours

    Can the participant tolerate the administration of the device with minimal discomfort?

  • Ability to visualize gastrointestinal features6 months

    Can the technology successfully visualize gastrointestinal features?