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Intestinal Dysmotility in Patients With Functional Digestive Symptoms

Sponsor
Hospital Universitari Vall d'Hebron Research Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT04764019
Collaborator
Instituto de Salud Carlos III (Other)
50
Enrollment
1
Location
1
Arm
39.7
Anticipated Duration (Months)
1.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Automatic and non-invasive diagnostic methods based on the analysis of internal (intraluminal) and external (abdominal) images have been recently developed to measure intestinal motility. In patients with severe motor disorders, such as intestinal pseudo-obstruction, these new non-invasive techniques have shown to be equivalent to conventional intestinal manometry, the current gold-standard. However, these new techniques also detect less obvious signs of intestinal motor dysfunction, which are not detectable by conventional manometry.

High resolution manometry has been recently been applied to other parts of the digestive tract with great success, and probably will replace the actual gold-standard for intestinal motility evaluation. The investigators expect high-resolution manometry to be more sensitive than conventional manometry to the subtle motility disturbances detected by the new non-invasive techniques.

The purpose of this project is to demonstrate that intestinal motor function can be measured more sensitively and accurately using a combination of new technologies: high resolution manometry and the non-invasive diagnostic methods based on the analysis of images. The combined use of these techniques, following a step-wise algorithm, could allow to determine the mechanism, the affected regions and severity of the dysfunction in patients with intestinal dysmotility.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: High resolution intestinal manometry
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Intestinal Dysmotility in Patients With Functional Digestive Symptoms
Actual Study Start Date :
Nov 7, 2018
Actual Primary Completion Date :
Jul 15, 2021
Anticipated Study Completion Date :
Feb 28, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Patients

Patients with chronic digestive symptoms in whom intestinal dysmotility is suspected

Diagnostic Test: High resolution intestinal manometry
Evaluation of intestinal manometry by the use a high resolution intestinal manometry catheter with 34 closely spaced sensors.

Outcome Measures

Primary Outcome Measures

  1. Contractile activity [10 minutes]

    Number of contractions

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:

  • Patients: digestive symptoms

  • Healthy subjects: asymptomatic

Exclusion Criteria:

  • Patients: organic disorders

  • Healthy subjects: organic disorders

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hospital Vall d'Hebron Barcelona Spain 08035

Sponsors and Collaborators

  • Hospital Universitari Vall d'Hebron Research Institute
  • Instituto de Salud Carlos III

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier:
NCT04764019
Other Study ID Numbers:
  • PR(AG)56/2018
First Posted:
Feb 21, 2021
Last Update Posted:
Nov 22, 2021
Last Verified:
Mar 1, 2021
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No

Study Results

No Results Posted as of Nov 22, 2021