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Enrolling By Invitation
NCT04984447
OCT Guided Trans Nasal Imaging of the Small Intestine in Adults
Conditions: Environmental Enteric Dysfunction
Sex: All
Ages: 18 Years – 60 Years
Healthy volunteers: Yes
Phase: NA
Enrollment: 30
Sponsor: Massachusetts General Hospital
Location: Massachusetts General Hospital Boston Massachusetts
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* Healthy participants
* Participants who are in their 2nd trimester of pregnancy
* Participant must be 18-60 years of age
* Participant must be able to consent to the procedure.
* Participant must fast (no solid food) for at least 8 hours and have no liquids within 2 hours prior to the procedure.
Exclusion Criteria:
* Participants 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
* Participants 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
* Participants with upper respiratory infection at least 7 days prior to the procedure
* Pariticipants 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.
* Participants on medications that delay gastric emptying.
* Participants on drugs which impair clotting like anticoagulants and antiplatelet drugs, NSAIDS, history of bleeding disorders.
* Participants using nasal steroids or any steroids for environmental allergies.
Source: ClinicalTrials.gov (NCT04984447). StuddyBuddy aggregates publicly available trial information.