Real-World Clinical Study on the Efficacy of Vibrating Capsule (Vibrabot Capsule) for Chronic Functional Constipation

Launched by CHANGHAI HOSPITAL · May 15, 2024

Keywords

ClinConnect Summary

This clinical trial is studying the effectiveness of a new treatment called the Vibrabot capsule for people who have chronic functional constipation. The study aims to include 300 patients with this condition, comparing their results with another group of patients receiving standard constipation treatments. Participants will be asked to provide information about their health, their current constipation situation, and their treatment history. During the trial, they will take the Vibrabot capsules as directed by their doctors, while also maintaining a balanced diet and regular exercise.

To join the study, patients must meet certain criteria, such as being diagnosed with functional constipation according to specific guidelines and agreeing to participate by signing a consent form. However, some individuals may not be eligible, including those with certain gastrointestinal issues, allergies, or serious health conditions. Participants will need to complete regular online questionnaires to track their progress, focusing on how often they have normal bowel movements during the treatment period. This trial is important because it could help find new ways to improve the lives of those suffering from chronic constipation.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Patients who can be diagnosed with functional constipation according to the Rome IV criteria.
• • 2. Patients who consent to participate in this trial and voluntarily sign the informed consent form (ICF).
• Exclusion Criteria:
• • 1. People who are not eligible for surgery or refuse to undergo any abdominal surgery;
• • 2. People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
• • 3. People allergic to polymeric materials;
• • 4. People implanted with cardiac pacemakers and using gastrointestinal pacemakers;
• • 5. People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies.
• • 6. People with dysphagia;
• • 7. Pregnant women;
• • 8. People with severe depression and anxiety and severe acute gastrointestinal lesions.
• • 9. People with other conditions, so the investigator considers them not eligible for this study.