NCT05205239

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2021

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2021

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

January 11, 2022

Completed
14 days until next milestone

First Posted

Study publicly available on registry

January 25, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2022

Completed
Last Updated

January 25, 2022

Status Verified

October 1, 2021

Enrollment Period

12 months

First QC Date

January 11, 2022

Last Update Submit

January 11, 2022

Conditions

System Sclerosis

Outcome Measures

Primary Outcomes (1)

  • Motility index score

    8 hours

Study Arms (1)

Systemic sclerosis

EXPERIMENTAL
Diagnostic Test: Endoluminal image analysis by capsule endoscopy

Interventions

Endoluminal image analysis by capsule endoscopyDIAGNOSTIC_TEST

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.

Systemic sclerosis

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Systemic sclerosis diagnosed by ACR criteria

You may not qualify if:

  • Lung transplantation
  • End stage kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Vall d'Hebron

Barcelona, 08035, Spain

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26251472BACKGROUND

  • 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.

    PMID: 27810622BACKGROUND

  • 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.

    PMID: 32475007BACKGROUND

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Central Study Contacts

Luis Alcala, MD

CONTACT

34 695101188lalcala@vhebron.net

Carolina Malagelada, MD

CONTACT

+34932746259cmalagelada@vhebron.net

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 11, 2022

First Posted

January 25, 2022

Study Start

July 1, 2021

Primary Completion

June 30, 2022

Study Completion

August 31, 2022

Last Updated

January 25, 2022

Record last verified: 2021-10

Locations

ES(1)