OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Environmental Enteric Dysfunction
• Intervention / Treatment: Device: TNIB Catheter

Detailed Description

The investigators have developed a device that can image the duodenum (the first part of the small intestine). The device consists of a thin, flexible tube with a small internal camera inside of it that takes high-resolution images of the gastrointestinal tract. The device will be introduced through the nose and then advanced into the stomach and duodenum. Participant tolerability, imaging quality and the optimal imaging technique will be evaluated. The results of this study will be used as the basis for a larger study to be conducted at the Aga Khan University Hospital in Pakistan where subjects with suspected or diagnosed EED will be imaged.

• Study Type: Interventional
• Enrollment (Estimated): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• 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 Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Feasibility of TNIB catheter; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Ability to visualize gastrointestinal features	Can the technology successfully visualize gastrointestinal features?	6 months
Ability for participant to tolerate the device	Can the participant tolerate the administration of the device with minimal discomfort?	3 hours

Collaborators and Investigators

• Sponsor: Massachusetts General Hospital
• Collaborators: Bill and Melinda Gates Foundation
• Investigators: Principal Investigator: Guillermo Tearney, M.D, PhD., Massachusetts General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 22, 2017
• Primary Completion (Estimated): December 1, 2027
• Study Completion (Estimated): December 1, 2029

Study Registration Dates

• First Submitted: August 11, 2020
• First Submitted That Met QC Criteria: July 21, 2021
• First Posted (Actual): July 30, 2021

Study Record Updates

• Last Update Posted (Estimated): October 22, 2025
• Last Update Submitted That Met QC Criteria: October 20, 2025
• Last Verified: October 1, 2025

More Information

Terms related to this study

• Keywords: Imaging; Diagnosis; GI; Tropical Enteropathy; EED; Environmental Enteric Dysfunction; Environmental Enteropathy; Tethered Capsule Endoscopy
• Additional Relevant MeSH Terms: Pathologic Processes; Metabolic Diseases; Intestinal Diseases; Digestive System Diseases; Gastrointestinal Diseases; Malabsorption Syndromes; Pathological Conditions, Signs and Symptoms; Nutritional and Metabolic Diseases; Disease; Sprue, Tropical
• Other Study ID Numbers: 2017P001428

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No