OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Recruiting

CT.gov ID

NCT04984447

Collaborator

Bill and Melinda Gates Foundation (Other)

Enrollment

Location

Arm

80.3

Anticipated Duration (Months)

0.4

Patients Per Site Per Month

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
Environmental Enteric Dysfunction	Device: TNIB Catheter	N/A

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:

Interventional

Anticipated Enrollment :

30 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

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.

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

Ability for subject to tolerate the device [3 hours]
Can the subject tolerate the administration of the device with minimal discomfort?
Ability to visualize gastrointestinal features [6 months]
Can the technology successfully visualize gastrointestinal features?

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.