OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

Not Applicable

• Conditions: Environmental Enteric Dysfunction
• Interventions: Device: TNIB Catheter

• Registration Number: NCT04984447
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study Start: 2017-09-22
• Study First Submitted: 2020-08-11
• Study First Submitted QC: 2021-07-21
• Study First Posted: 2021-07-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-09
• Last Update Posted: 2024-05-13
• Primary Completion: 2026-12
• Study Completion: 2028-12

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 30

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility of TNIB catheter	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

Primary Outcome Measures

Name	Time	Method
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?

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States