Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan (NCT04275167) | Clinical Trial Compass
By InvitationNot Applicable
Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan
Pakistan170 participantsStarted 2017-10-11
Plain-language 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 and a matched non-EED cohort. This study will assess subject tolerability, optimal imaging technique, and imaging of EED features.
Who can participate
Age range
6 Months – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
The Inclusion Criteria:
* Children must be 6 months to 59 months old
* Adult participants 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
* Participants and/or parents/guardians must be able to give informed consent/assent
* Participants and/or parents/guardians must be willing to provide consent for live streaming of the procedure
* Participants must be able to follow fasting instructions prior to the procedure
Inclusion criteria for Pregnant women:
* Participants 18 years and older
* Participants who are in their 2nd trimester of singleton pregnancy as confirmed by an ultrasound
* Participants with a BMI below 18.5 without clear etiology and healthy pregnant women with BMI between 18.5 -24.5.
* Participants must be able to follow fasting instructions prior to the procedure
* Participants must be able to consent to the procedure
Tethered Capsule Exclusion Criteria:
* Participants with any history of esophageal or intestinal strictures or prior GI surgery
* Participants with history of pyloric stenosis
* Participants with HIV diagnosis
Trans Nasal Exclusion Criteria:
* Participants with any contraindications for NG/NJ tube placement, including but not limited to those listed below:
* Participants with any history of esophageal or intestinal strictures or prior GI surgery
* Participants with history of pyloric stenosis or atresia
* Participants with…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.