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

Summary

This study is a multi-center prospective cohort study, which plans to include 300 patients with chronic functional constipation to treat with Vibrabot capsules, and at the same time, include ≥300 patients receiving constipation treatment during the same period.

During the study, it is necessary to collect the patients' basic information, baseline constipation status and treatment information, capsule intake during treatment, and concomitant medication. 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 scan the two-dimensional code or search for the electronic questionnaire "Vibrabot Health" Official Account on WeChat, and 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).

Conditions

• Clinical Study
• Chronic Functional Constipation

Interventions

DEVICE

Treatment with Vibrating 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.

Sponsors & Collaborators

• Ruijin Hospital

  collaborator OTHER

• Shanghai Tongji Hospital, Tongji University School of Medicine

  collaborator OTHER

• Shanghai 10th People's Hospital

  collaborator OTHER

• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine

  collaborator OTHER

• Shanghai 6th People's Hospital

  collaborator OTHER

• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University

  collaborator OTHER

• Shanghai Pudong New Area Gongli Hospital

  collaborator OTHER

• Changhai Hospital

  lead OTHER

Principal Investigators

• Zhuan Liao, MD · Changhai Hospital

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-06-01

Primary Completion

2025-12-31

Completion

2026-06-01

Countries

• China

Study Locations