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MOWOOT Device to Treat Constipation in Adults

NCT04262752 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-04-23

No results posted yet for this study

Summary

The aim was to assess the safety and effectiveness of the automatic colon-specific massage with the MOWOOT device for patients suffering from chronic constipation due to Multiple Sclerosis, Parkinson Disease (NBD) or other unknown causes (Idiopathic).The hypothesis is that this treatment administered daily in home-use settings could ameliorate constipation in chronically affected people.

Conditions

  • Constipation
  • Constipation; Neurogenic
  • Constipation Chronic Idiopathic

Interventions

DEVICE

intermittent colonic exo-peristaltic massage treatment with the MOWOOT medical device

The MOWOOT massager belt is connected to the desktop device and is the component which is in contact with the subject giving the abdominal massage action. The massager belt, which is placed on the user's abdominal area, administers a specific abdominal massage on the ascendant and descendent segments of the colon. This massage emulates the techniques used by professional therapists through a series of pneumatic actuators operating like the movement of a wave transmitting movement through the colon. The type and speed of the massage can usually be regulated by an algorithm that controls the operation from the desktop device. For the present clinical trial, time and force will stay fixed on 20 minutes and force 3 (0'6-0'7 bar). Subjects will not be able to choose other massage options. Subjects should use the MOWOOT device once a day for 20 min (1 complete treatment) ideally at the same hour every day for the 4 weeks of the interventional treatment period.

Sponsors & Collaborators

  • usMIMA S.L.

    lead INDUSTRY

Principal Investigators

  • Immaculada Herrero-Fresneda, PhD · usMIMA S.L.

  • Doreen McClurg, PhD · Glasgow Caledonian University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-11
Primary Completion
2019-05-13
Completion
2019-06-07

Countries

  • Spain
  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04262752 on ClinicalTrials.gov