Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intestinal Dysmotility in Patients With Functional Digestive Symptoms

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04764019
Recruitment Status : Recruiting
First Posted : February 21, 2021
Last Update Posted : November 22, 2021
Sponsor:
Collaborator:
Instituto de Salud Carlos III
Information provided by (Responsible Party):
Hospital Universitari Vall d'Hebron Research Institute

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Gastrointestinal Motility Disorder Diagnostic Test: High resolution intestinal manometry Not Applicable

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated 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 : November 7, 2018
Actual Primary Completion Date : July 15, 2021
Estimated Study Completion Date : February 28, 2022
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Contractile activity [ Time Frame: 10 minutes ]
    Number of contractions


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients: digestive symptoms
  • Healthy subjects: asymptomatic

Exclusion Criteria:

  • Patients: organic disorders
  • Healthy subjects: organic disorders
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04764019


Contacts
Layout table for location contacts
Contact: Carolina Malagelada, MD 34 932746259 cmalagelada@vhebron.net
Contact: Fernando Azpiroz, MD 34932746259 azpiroz.fernando@gmail.com

Locations
Layout table for location information
Spain
Hospital Vall d'Hebron Recruiting
Barcelona, Spain, 08035
Contact: Carolina Malagelada, MD    34 932746259    cmalagelada@vhebron.net   
Sponsors and Collaborators
Hospital Universitari Vall d'Hebron Research Institute
Instituto de Salud Carlos III
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Hospital Universitari Vall d'Hebron Research Institute
ClinicalTrials.gov Identifier: NCT04764019    
Other Study ID Numbers: PR(AG)56/2018
First Posted: February 21, 2021    Key Record Dates
Last Update Posted: November 22, 2021
Last Verified: March 2021

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No