Status:
ENROLLING_BY_INVITATION
Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan
Lead Sponsor:
Massachusetts General Hospital
Collaborating Sponsors:
Bill and Melinda Gates Foundation
Aga Khan University Hospital, Pakistan
Conditions:
Environmental Enteric Dysfunction
Eligibility:
All Genders
6-70 years
Phase:
NA
Brief Summary
This pilot study will test the feasibility and tolerability of the tethered OCT capsule and Trans Nasal Endomicroscopy probe and accessory devices for imaging the small intestine in subjects with EED ...
Detailed Description
Environmental enteric dysfunction (EED) is a poorly understood condition characterized by intestinal inflammation and loss of barrier function that is prevalent in regions of the world with inadequate...
Eligibility Criteria
Inclusion
- The
- Children must be 6 months to 59 months old
- Adult subjects 18 years of age or older scheduled for a standard of care endoscopy
- EED manifesting as malnourishment (WHZ\<-2) without clear etiology or healthy subjects with WHZ \>=0
- Subjects and/or parents/guardians must be able to give informed consent/assent
- Subjects and/or parents/guardians must be willing to provide consent for live streaming of the procedure
- Subjects must be able to follow fasting instructions prior to the procedure
- Inclusion criteria for Pregnant women:
- Subjects 18 years and older
- Subjects who are in their 2nd trimester of singleton pregnancy as confirmed by an ultrasound
- Subjects with a BMI below 18.5 without clear etiology and healthy pregnant women with BMI between 18.5 -24.5.
- Subjects must be able to follow fasting instructions prior to the procedure
- Subjects must be able to consent to the procedure
- Tethered Capsule
Exclusion
- Subjects with any history of esophageal or intestinal strictures or prior GI surgery
- Subjects with history of pyloric stenosis
- Subjects with HIV diagnosis
- Trans Nasal
Key Trial Info
Start Date :
October 11 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 1 2029
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT04275167
Start Date
October 11 2017
End Date
January 1 2029
Last Update
May 13 2024
Active Locations (1)
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1
Aga Khan Medical Center
Karachi, Pakistan