Small Bowel Motility in Patients With Systemic Sclerosis

Not Applicable

• Conditions: System Sclerosis
• Interventions: Diagnostic Test: Endoluminal image analysis by capsule endoscopy

• Registration Number: NCT05205239
• Lead Sponsor: Hospital Universitari Vall d'Hebron Research Institute

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-01
• Status Verified: 2021-10
• Study First Submitted: 2022-01-11
• Study First Submitted QC: 2022-01-11
• Last Update Submitted: 2022-01-11
• Study First Posted: 2022-01-25
• Last Update Posted: 2022-01-25
• Primary Completion: 2022-06-30
• Study Completion: 2022-08-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Systemic sclerosis diagnosed by ACR criteria

Exclusion Criteria

• Lung transplantation
• End stage kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Systemic sclerosis	Endoluminal image analysis by capsule endoscopy	-

Primary Outcome Measures

Name	Time	Method
Motility index score	8 hours

Trial Locations

Locations (1)

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain