OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

NCT04984447 | Enrolling By Invitation FDA Device

• 1 other identifier: 2017P001428
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

The investigators are seeking healthy adult participants 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.

Conditions

Environmental Enteric Dysfunction

Keywords

EED; Environmental Enteric Dysfunction; Environmental Enteropathy; Tropical Enteropathy; GI; Tethered Capsule Endoscopy; Imaging; Diagnosis

Outcome Measures

Primary Outcomes (2)

• Ability for participant to tolerate the device

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

  3 hours

• Ability to visualize gastrointestinal features

  Can the technology successfully visualize gastrointestinal features?

  6 months

Study Arms (1)

Feasibility of TNIB catheter

EXPERIMENTAL

The feasibility of using the TNIB catheter to obtain microscopic images of the intestine. Healthy adult participants, 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

Device: TNIB Catheter

Interventions

TNIB Catheter DEVICE

Pariticipants will be asked to fast for 8 hours prior to study procedure and no liquids 2 hours prior to study procedure. Lidocaine jelly will may be used to help insert the TNIB Catheter through the Nares. Once inserted past the pharynx, imaging will begin. We will attempt to image the duodenum within 3 hours of study procedure starting.

Feasibility of TNIB catheter

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Massachusetts General Hospital: lead
• Bill and Melinda Gates Foundation: collaborator

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Sprue, Tropical; Disease

Condition Hierarchy (Ancestors)

Malabsorption Syndromes; Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Guillermo Tearney, M.D, PhD.

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Guillermo J. Tearney, MD, PhD - Principal Investigator

Study Record Dates

• First Submitted: August 11, 2020
• First Posted: July 30, 2021
• Study Start: September 22, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029
• Last Updated: October 22, 2025

Record last verified: 2025-10

Locations

US (1)