OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

Massachusetts General Hospital (Other)
Overall Status
CT.gov ID
Bill and Melinda Gates Foundation (Other)

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Anticipated Enrollment :
30 participants
Intervention Model:
Single Group Assignment
None (Open Label)
Primary Purpose:
Device Feasibility
Official Title:
OCT Guided Trans Nasal Imaging of the Small Intestine in Adults
Actual Study Start Date :
Sep 22, 2017
Anticipated Primary Completion Date :
Jun 1, 2023
Anticipated Study Completion Date :
Jun 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Feasibility of TNIB catheter

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

Device: TNIB Catheter
Subjects 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.

Outcome Measures

Primary Outcome Measures

  1. Ability for subject to tolerate the device [3 hours]

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

  2. Ability to visualize gastrointestinal features [6 months]

    Can the technology successfully visualize gastrointestinal features?

Eligibility Criteria


Ages Eligible for Study:
18 Years to 60 Years
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Inclusion Criteria:
  • Healthy subjects

  • Subjects who are in their 2nd trimester of pregnancy

  • Subject must be 18-60 years of age Subject must be able to consent to the procedure.

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

Exclusion Criteria:
  • Subjects 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

  • Subjects 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

  • Subjects with upper respiratory infection at least 7 days prior to the procedure

  • Subjects 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.

  • Subjects on medications that delay gastric emptying.

  • Patients on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.

  • Subjects using nasal steroids or any steroids for environmental allergies.

Contacts and Locations


Site City State Country Postal Code
1 Massachusetts General Hospital Boston Massachusetts United States 02114

Sponsors and Collaborators

  • Massachusetts General Hospital
  • Bill and Melinda Gates Foundation


  • Principal Investigator: Guillermo Tearney, M.D, PhD., Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information


None provided.
Responsible Party:
Guillermo Tearney, Guillermo J. Tearney, MD, PhD - Principal Investigator, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
Other Study ID Numbers:
  • 2017P001428
First Posted:
Jul 30, 2021
Last Update Posted:
Jul 30, 2021
Last Verified:
Jul 1, 2021
Studies a U.S. FDA-regulated Drug Product:
Studies a U.S. FDA-regulated Device Product:
Product Manufactured in and Exported from the U.S.:
Keywords provided by Guillermo Tearney, Guillermo J. Tearney, MD, PhD - Principal Investigator, Massachusetts General Hospital

Study Results

No Results Posted as of Jul 30, 2021