OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

Study Overview
=================
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.

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.

Official Title
-----------------
OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

Conditions
-----------------
Environmental Enteric Dysfunction

Intervention / Treatment
-----------------
* Device: TNIB Catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
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.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Feasibility of TNIB catheter<br>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<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability for subject to tolerate the device | Can the subject 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EED, Environmental Enteric Dysfunction, Environmental Enteropathy, Tropical Enteropathy, GI, Tethered Capsule Endoscopy, Imaging, Diagnosis