Intestinal Dysmotility in Patients With Functional Digestive Symptoms
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Nov 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2018
CompletedFirst Submitted
Initial submission to the registry
February 17, 2021
CompletedFirst Posted
Study publicly available on registry
February 21, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 15, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2022
CompletedNovember 22, 2021
March 1, 2021
2.7 years
February 17, 2021
November 18, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Contractile activity
Number of contractions
10 minutes
Study Arms (1)
Patients
EXPERIMENTALPatients with chronic digestive symptoms in whom intestinal dysmotility is suspected
Interventions
Evaluation of intestinal manometry by the use a high resolution intestinal manometry catheter with 34 closely spaced sensors.
Eligibility Criteria
You may qualify if:
- Patients: digestive symptoms
- Healthy subjects: asymptomatic
You may not qualify if:
- Patients: organic disorders
- Healthy subjects: organic disorders
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Vall d'Hebron
Barcelona, 08035, Spain
Related Publications (1)
Malagelada C, Karunaratne TB, Accarino A, Cogliandro RF, Landolfi S, Gori A, Boschetti E, Malagelada JR, Stanghellini V, Azpiroz F, De Giorgio R. Comparison between small bowel manometric patterns and full-thickness biopsy histopathology in severe intestinal dysmotility. Neurogastroenterol Motil. 2018 Mar;30(3). doi: 10.1111/nmo.13219. Epub 2017 Sep 22.
PMID: 28941004BACKGROUND
Central Study Contacts
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
February 17, 2021
First Posted
February 21, 2021
Study Start
November 7, 2018
Primary Completion
July 15, 2021
Study Completion
February 28, 2022
Last Updated
November 22, 2021
Record last verified: 2021-03