OCT Guided Trans Nasal Imaging of the Small Intestine in Adults

  • STATUS
    Recruiting
  • End date
    Jun 5, 2024
  • participants needed
    30
  • sponsor
    Massachusetts General Hospital
Updated on 5 August 2021

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.

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.

Details
Condition Environmental Enteric Dysfunction
Treatment TNIB Catheter
Clinical Study IdentifierNCT04984447
SponsorMassachusetts General Hospital
Last Modified on5 August 2021

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note