OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

Conditions

• Environmental Enteric Dysfunction

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Accepted

Interventions

• TNIB Catheter — DEVICE
  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.

Study Details

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.

Key Dates

Start date

Sep 22, 2017

Status verified

Oct 2025

Primary completion

Dec 31, 2027

Completion

Dec 31, 2029

Study Design

Enrollment

30 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Arms

• 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

Primary Outcome Measure

Ability for participant to tolerate the device [ Time Frame: 3 hours ]

Locations (1)

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