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Effect of Vibration Capsule on Different Subtypes of Functional Constipation
Sponsor: Changhai Hospital
Summary
This study is a multi-center prospective cohort study, which plans to include 600 patients with chronic functional constipation to treat with Vibrabot capsules and patients will be grouped according to subtypes. During the study, the patients' basic information, baseline constipation status and treatment information, capsule intake during treatment, and concomitant medication will be collected. During the treatment phase, patients follow the doctor's advice to receive Vibrabot capsule treatment and maintain stable dietary intake and exercise according to the constipation diagnosis and treatment guidelines. During the study, patients need to fill in the relevant information during the treatment in the electronic questionnaire in a timely and truthful manner. The treatment effect of the patients is evaluated by assessing the number of occurrences of spontaneous bowel movements (SBM) and complete spontaneous bowel movements (CSBM).
Official title: A Prospective Cohort Study On the Efficacy of Vibrating Capsule For Different Subtypes of Chronic Functional Constipation
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
600
Start Date
2024-06-01
Completion Date
2026-07-01
Last Updated
2024-05-10
Healthy Volunteers
No
Interventions
Vibrabot capsule
Main parameters of Vibrabot capsule: nominal diameter: 11.8±1mm; nominal length: 26.7±1mm; nominal weight: 4.5±1g. After the patient swallows the Vibrabot capsule, the capsule runs through the stomach → duodenum → jejunum and ileum → colon. According to the clinical data and configuration settings, the capsule will reach the colon and vibrate 8 hours after activation for ≥ 180 minutes in a cycle at low, medium, and high frequencies sequentially. The capsule relieves and treats constipation by massaging the colon wall through motor vibration to relieve colon muscle spasms and promote colonic peristalsis. The VC well be taken between 21:00 and 22:00 every day, and the frequency of administration is determined based on the patient's individual situation.
Locations (1)
Changhai hospital
Shanghai, China