Back to resultsSmall Bowel Motility in Patients With Systemic Sclerosis
Primary Purpose
System Sclerosis
Status
Unknown status
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Endoluminal image analysis by capsule endoscopy
Sponsored by
About this trial
This is an interventional diagnostic trial for System Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Systemic sclerosis diagnosed by ACR criteria
Exclusion Criteria:
- Lung transplantation
- End stage kidney disease
Sites / Locations
- Hospital Vall d'HebronRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Systemic sclerosis
Arm Description
Outcomes
Primary Outcome Measures
Motility index score
Secondary Outcome Measures
Full Information
NCT ID
NCT05205239
First Posted
January 11, 2022
Last Updated
January 11, 2022
Sponsor
Hospital Universitari Vall d'Hebron Research Institute
1. Study Identification
Unique Protocol Identification Number
NCT05205239
Brief Title
Small Bowel Motility in Patients With Systemic Sclerosis
Official Title
Intestinal Dysmotility in Patients With Functional Digestive Symptoms
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
July 1, 2021 (Actual)
Primary Completion Date
June 30, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hospital Universitari Vall d'Hebron Research Institute
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Several studies using intestinal manometry have reported alterations in small bowel motility in patients with systemic sclerosis. Our aim is to apply endoluminal image analysis to stratify the intestinal motor dysfunction in these patients can be assessed by non-invasive techniques. Consecutive patients with systemic sclerosis referred to our institution will be prospectively investigated using automated non-invasive techniques developed in our laboratory. Intraluminal images of the gut were obtained by capsule endoscopy. Endoluminal image analysis will be performed with original, previously validated programs based on computer vision and machine learning techniques.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
System Sclerosis
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Systemic sclerosis
Arm Type
Experimental
Intervention Type
Diagnostic Test
Intervention Name(s)
Endoluminal image analysis by capsule endoscopy
Intervention Description
Studies will be performed after discontinuation of medications that could affect gastrointestinal motility for at least 48 hours and overnight fast. Endoluminal images were obtained with the Pillcam capsule (Pillcam SB3 video capsule; Medtronic). Images will be obtained at a fixed 2 per second rate and recorded for a total of 8 hours with the subjects lying comfortably on a hospital bed and the trunk raised 30° above horizontal. Forty-five minutes after gastric exit, participants will be instructed to ingest a liquid meal (Ensure HN; Abbott; 300 mL,1 Kcal/mL). Endoluminal images of the small bowel will be analyzed with a computer program specifically developed in our laboratory for the evaluation of intestinal motility. This previously validated program is based on computer vision techniques, which allow the detection and quantification of contractile and non-contractile patterns characterizing small bowel motility.
Primary Outcome Measure Information:
Title
Motility index score
Time Frame
8 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Systemic sclerosis diagnosed by ACR criteria
Exclusion Criteria:
Lung transplantation
End stage kidney disease
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Luis Alcala, MD
Phone
34 695101188
Email
lalcala@vhebron.net
First Name & Middle Initial & Last Name or Official Title & Degree
Carolina Malagelada, MD
Phone
+34932746259
Email
cmalagelada@vhebron.net
Facility Information:
Facility Name
Hospital Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis Alcala, MD
Phone
932746259
Email
lalacala@vhebron.net
First Name & Middle Initial & Last Name & Degree
Carolina Malagelada, MD
Phone
+34932746259
Email
cmalagelada@vhebron.net
12. IPD Sharing Statement
Citations:
PubMed Identifier
26251472
Citation
Malagelada C, Drozdzal M, Segui S, Mendez S, Vitria J, Radeva P, Santos J, Accarino A, Malagelada JR, Azpiroz F. Classification of functional bowel disorders by objective physiological criteria based on endoluminal image analysis. Am J Physiol Gastrointest Liver Physiol. 2015 Sep 15;309(6):G413-9. doi: 10.1152/ajpgi.00193.2015. Epub 2015 Aug 6.
Results Reference
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PubMed Identifier
27810622
Citation
Segui S, Drozdzal M, Pascual G, Radeva P, Malagelada C, Azpiroz F, Vitria J. Generic feature learning for wireless capsule endoscopy analysis. Comput Biol Med. 2016 Dec 1;79:163-172. doi: 10.1016/j.compbiomed.2016.10.011. Epub 2016 Oct 19.
Results Reference
background
PubMed Identifier
32475007
Citation
Malagelada C, Bendezu RA, Segui S, Vitria J, Merino X, Nieto A, Sihuay D, Accarino A, Molero X, Azpiroz F. Motor dysfunction of the gut in cystic fibrosis. Neurogastroenterol Motil. 2020 Sep;32(9):e13883. doi: 10.1111/nmo.13883. Epub 2020 May 31.
Results Reference
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Small Bowel Motility in Patients With Systemic Sclerosis
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