Ignite Creation Date:
2024-05-06 @ 2:17 PM
Last Modification Date:
2024-10-26 @ 1:28 PM
Study NCT ID:
NCT04275167
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-05-13
First Post:
2019-12-09
Brief Title:
Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Capsule Endomicroscopy for Visualization of the Small Intestine in EED Population in Pakistan
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 and a matched non-EED cohort This study will assess subject tolerability optimal imaging technique and imaging of EED features
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 sanitation and hygiene EED is a major driver of malnourishment poor neurological development stunting oral vaccine failure and infection affecting 25 of all children globally and causing over a million deaths each year It is hypothesized that the stunting associated with EED begins in utero and that the mothers gut health has a significant impact on the fetus Key periods of growth from pregnancy through birth and childhood offer windows for potential intervention Progress towards understanding EED and developing effective interventions has been hampered by an inability to evaluate the intestinal mucosa of populations in impoverished regions of the world where this condition is endemic
The Tearney Laboratory has developed a minimally invasive screening method known as tethered capsule endomicroscopy TCE for imaging intestinal mucosa With TCE an unsedated subject swallows a tethered pill which captures microscopic images of the entire esophagus stomach and small intestine as it is naturally transits these organs via peristalsis and under the influence of gravity The capsule implements a microscopic imaging technology called optical coherence tomography OCT that obtains 10-µm-resolution cross-sectional images of tissue The procedure is brief well tolerated and can be much less expensive than endoscopy The Investigators have implemented TCE for imaging the upper gastrointestinal tract of adults and adolescents with Celiac Disease CD and eosinophilic esophagitis EoE inflammatory conditions that are common in the US The qualities seen thus far in their TCE studies - high imaging resolution comprehensive tissue assessment and minimal invasiveness - are also the qualities needed for evaluating the intestinal mucosa in populations with EED
The Tearney Lab has also developed a new technique of deployment Trans Nasal Endomicroscopy TNE The TNE catheter comprises of an introduction tube similar to a standard Nasojejunal tube with one or two balloons attached at the distal end These balloons are inflated with Galinstan a safe liquid metal alloy used in pediatric thermometers or saline or sugar water or air which provides weight for the device to move to the duodenum under the forces of gravity and peristalsis The TNE catheter encloses the OCT optics within and is designed to have many of the same imaging properties of TCE but is introduced Trans nasally so that it can be effectively used in children infants and also enable collection of various tissue samples using accessory probes for analysis through the lumen of the introduction tube
There have been theories proposed that increased microorganism load andor dysbiosis or an imbalance in the composition of gut microorganisms in the intestine may be important in the establishment andor maintenance of EED Duodenal Aspiration during endoscopy is currently used as gold standard for standard of care to collect targeted microbiome However the microbiome yield from this procedure is low and the procedure requires an EGD which is a fairly invasive procedure and carries all of the risks associated with an EGD Tearney lab has developed a brush that can collect microbiota samples from the small intestine in the unsedated subject in a non-invasive manner The brush is similar to cytology brush used in standard clinical care designed to be deployed through the TNIT tube
The first phase of this study will test the feasibility and tolerability of the TCE device for imaging subjects with EED The second phase of this study will test the TNE device and its accessories for imaging and microbial sample collection in pregnant women
The Tearney Laboratory has developed a minimally invasive screening method known as tethered capsule endomicroscopy TCE for imaging intestinal mucosa With TCE an unsedated subject swallows a tethered pill which captures microscopic images of the entire esophagus stomach and small intestine as it is naturally transits these organs via peristalsis and under the influence of gravity The capsule implements a microscopic imaging technology called optical coherence tomography OCT that obtains 10-µm-resolution cross-sectional images of tissue The procedure is brief well tolerated and can be much less expensive than endoscopy The Investigators have implemented TCE for imaging the upper gastrointestinal tract of adults and adolescents with Celiac Disease CD and eosinophilic esophagitis EoE inflammatory conditions that are common in the US The qualities seen thus far in their TCE studies - high imaging resolution comprehensive tissue assessment and minimal invasiveness - are also the qualities needed for evaluating the intestinal mucosa in populations with EED
The Tearney Lab has also developed a new technique of deployment Trans Nasal Endomicroscopy TNE The TNE catheter comprises of an introduction tube similar to a standard Nasojejunal tube with one or two balloons attached at the distal end These balloons are inflated with Galinstan a safe liquid metal alloy used in pediatric thermometers or saline or sugar water or air which provides weight for the device to move to the duodenum under the forces of gravity and peristalsis The TNE catheter encloses the OCT optics within and is designed to have many of the same imaging properties of TCE but is introduced Trans nasally so that it can be effectively used in children infants and also enable collection of various tissue samples using accessory probes for analysis through the lumen of the introduction tube
There have been theories proposed that increased microorganism load andor dysbiosis or an imbalance in the composition of gut microorganisms in the intestine may be important in the establishment andor maintenance of EED Duodenal Aspiration during endoscopy is currently used as gold standard for standard of care to collect targeted microbiome However the microbiome yield from this procedure is low and the procedure requires an EGD which is a fairly invasive procedure and carries all of the risks associated with an EGD Tearney lab has developed a brush that can collect microbiota samples from the small intestine in the unsedated subject in a non-invasive manner The brush is similar to cytology brush used in standard clinical care designed to be deployed through the TNIT tube
The first phase of this study will test the feasibility and tolerability of the TCE device for imaging subjects with EED The second phase of this study will test the TNE device and its accessories for imaging and microbial sample collection in pregnant women
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None