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Effect of Vibration Capsule on Different Subtypes of Functional Constipation

NCT06408883 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-05-10

No results posted yet for this study

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).

Conditions

  • Clinical Study
  • Chronic Functional Constipation

Interventions

DEVICE

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.

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-06-01
Primary Completion
2025-12-31
Completion
2026-07-01

Countries

  • China

Study Locations

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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 NCT06408883 on ClinicalTrials.gov