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

NCT06418685 | Not Yet Recruiting DMC

• 1 other identifier: ANKONYX2023006
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Real-World Clinical Study; Vibrating Capsule; Chronic Functional Constipation; Response Rate; Complete Spontaneous Bowel Movement

Outcome Measures

Primary Outcomes (1)

• After treatment, whether the response rate of patients using the Vibrabot vibrating capsules alone reaches 50%.

  The definition of the responder is a patient with an average weekly increase of ≥1 complete spontaneous bowel movement (CSBM) compared to the baseline.

  At the end of the sixth week of treatment

Secondary Outcomes (10)

• Proportion of constipated patients who use/do not use other constipation treatment methods

  At the end of the sixth week of treatment

• Proportion of constipated patients who use/do not use other constipation treatment methods

  at the end of the 4-week follow-up

• Proportion of patients with an average increase of ≥1 CSBMs per week compared to the baseline period

  At the end of the sixth week of treatment

• Proportion of respondents with an average of ≥3 SBMs per week during the treatment period

  At the end of the sixth week of treatment

• Proportion of subjects with ≥3 SBMs per week and an increase of ≥1 CSBMs during at least 4 weeks of treatment compared to baseline

  At the end of the sixth week of treatment

Other Outcomes (2)

• Proportion of constipated patients (including different constipation types, occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment.

  At the end of the sixth week of treatment

• occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment.

  at the end of the 4-week follow-up period.

Study Arms (2)

VC group

Treatment with Vibrabot Capsule

Device: Treatment with Vibrating Capsule

Other treatment group

Selecting Alternative Treatment Methods through Assessment

Interventions

Treatment with Vibrating Capsule DEVICE

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.

VC group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study is a multi-center clinical trial. Patients are considered eligible for this study if they meet the inclusion criteria and do not meet any of the exclusion criteria. This study plans to include 300 patients with chronic functional constipation to treat with Vibrabot capsules for at least 6 weeks, and ≥300 patients with constipation receiving other treatments concurrently.

You may qualify if:

• Patients who can be diagnosed with functional constipation according to the Rome IV criteria.
• Patients who consent to participate in this trial and voluntarily sign the informed consent form (ICF).

You may not qualify if:

• People who are not eligible for surgery or refuse to undergo any abdominal surgery;
• People with known or suspected gastrointestinal obstruction, stenosis, diverticulum, bleeding, malformation, and fistula.
• People allergic to polymeric materials;
• People implanted with cardiac pacemakers and using gastrointestinal pacemakers;
• People with abdominal aortic aneurysms, gastrointestinal vascular lesions, ulcers, and lesions with bleeding tendencies.
• People with dysphagia;
• Pregnant women;
• People with severe depression and anxiety and severe acute gastrointestinal lesions.
• People with other conditions, so the investigator considers them not eligible for this study.

Sponsors & Collaborators

• Changhai Hospital: lead
• Ruijin Hospital: collaborator
• Shanghai Tongji Hospital, Tongji University School of Medicine: collaborator
• Shanghai 10th People's Hospital: collaborator
• Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine: collaborator
• Shanghai 6th People's Hospital: collaborator
• Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University: collaborator
• Shanghai Pudong New Area Gongli Hospital: collaborator

Study Sites (1)

Changhai hospital

Shanghai, China

Location

Related Publications (3)

• Scott SM, Simren M, Farmer AD, Dinning PG, Carrington EV, Benninga MA, Burgell RE, Dimidi E, Fikree A, Ford AC, Fox M, Hoad CL, Knowles CH, Krogh K, Nugent K, Remes-Troche JM, Whelan K, Corsetti M. Chronic constipation in adults: Contemporary perspectives and clinical challenges. 1: Epidemiology, diagnosis, clinical associations, pathophysiology and investigation. Neurogastroenterol Motil. 2021 Jun;33(6):e14050. doi: 10.1111/nmo.14050. Epub 2020 Dec 2.

  PMID: 33263938 BACKGROUND

• Zhu JH, Qian YY, Pan J, He C, Lan Y, Chen WN, Wang BM, Zhao W, Li JN, Li XQ, Lv B, Fan YH, Zuo XL, Li Z, Zou DW, Li ZS, Liao Z. Efficacy and safety of vibrating capsule for functional constipation (VICONS): A randomised, double-blind, placebo-controlled, multicenter trial. EClinicalMedicine. 2022 Apr 25;47:101407. doi: 10.1016/j.eclinm.2022.101407. eCollection 2022 May.

  PMID: 35518121 BACKGROUND

• Camilleri M, Kerstens R, Rykx A, Vandeplassche L. A placebo-controlled trial of prucalopride for severe chronic constipation. N Engl J Med. 2008 May 29;358(22):2344-54. doi: 10.1056/NEJMoa0800670.

  PMID: 18509121 BACKGROUND

MeSH Terms

Interventions

Therapeutics

Study Officials

• Zhuan Liao, MD

  Changhai Hospital

  STUDY CHAIR

Central Study Contacts

Yangyang Qian, MD

CONTACT

+86 13818040017; drfionachien@163.com

Jiahui Zhu, MD

CONTACT

+86 18301952685; jiahuizhu2685@126.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 30, 2024
• First Posted: May 17, 2024
• Study Start: June 1, 2024
• Primary Completion: December 31, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: May 17, 2024

Record last verified: 2024-01

Locations

CN (1)