Clinical trial NCT06418685: Real-World Clinical Study on the Efficacy of Vibrating Capsule (Vibrabot Capsule) for Chronic Functional Constipation
Official title: The First Affiliated Hospital of Naval Medical University
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Clinical Study
Chronic Functional Constipation
Keywords: Real-World Clinical Study
Vibrating Capsule
Chronic Functional Constipation
Response Rate
Complete Spontaneous Bowel Movement
Lead sponsor: Changhai Hospital
Sponsor class: OTHER
Collaborators: name: Ruijin Hospital
name: Shanghai Tongji Hospital, Tongji University School of Medicine
name: Shanghai 10th People's Hospital
name: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Shanghai 6th People's Hospital
name: Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University
name: Shanghai Pudong New Area Gongli Hospital
First posted: 2024-05-17
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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).

Detailed description: Constipation is characterized by a decrease in bowel movements, dry and hard stools, and difficulty in defecation. With changes in diet, faster pace of life, and social psychological factors, the prevalence of chronic constipation is on the rise. The global incidence of chronic constipation is 14%, while the prevalence of chronic constipation in adults in China is 4.0% to 10.0%. The prevalence of functional constipation in China is 6%. The high-risk groups for constipation include the elderly, women, diabetics, those taking opiates, antipsychotic drugs, or bedridden patients. Occupation, lifestyle, dietary habits, mental health, family history of constipation, and BMI are factors related to constipation.

Constipation affects patients' quality of life, and some patients abuse laxatives or repeatedly seek medical treatment, increasing medical costs. The main treatments for constipation are adjusting lifestyle, medication, psychotherapy, biofeedback, and surgery. However, these methods often have side effects, and patient satisfaction is still relatively low. A new approach needs to be explored to address this clinical problem.

The Disposable Gastrointestinal Vibrating Capsule System (Vibrabot capsule) (NMPA Device Approval No. 20223090282) is the world's first approved and marketed product for treating constipation through purely physical means. It can provide intermittent comfortable massages to the digestive tract, activate the intestinal neural network, awaken intestinal motility, and help alleviate constipation issues. Clinical study results show that the product is safe to use and can increase the frequency of bowel movements in patients with chronic functional constipation.

This study focuses on post-marketing clinical study for patients with functional constipation of varying severity, further evaluating the efficacy of the product in a large sample population.

Through this real-world study, to analyze the response of functional constipation patients with different severity, treatment status, capsule dosage, and combined medication to Vibrabot capsule, as well as the duration of efficacy maintenance during the follow-up period; to compare the efficacy with patients treated with drugs or other therapies during the same period, explore the possibility of curing functional constipation patients, further improve the treatment satisfaction of constipation patients, and promote the establishment and application of consensus or guidelines for the use of Vibrabot capsule in treating functional constipation.

Each patient will undergo a series of study visits, including screening, treatment visit, and follow-up visit. The visit process is briefly described as follows:

Visit 1 (0 \~ 1 day) - Baseline/Screening Period:

This visit includes:

The patient will sign an informed consent form; Set the inclusion/exclusion criteria; Guide patients to fill out the questionnaire using the Official Account and complete the Baseline Period Questionnaire in the Official Account.

Prescription Vibrabot capsule treatment or other treatment options.

Visit 2 (Week 2 ±3 days) - Treatment Period 1:

This visit includes:

Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.

Record adverse events and concomitant treatments; Prescription Vibrabot capsules or other treatment options. Visit 3 (Week 4±3 days) - Treatment Period 2

This visit includes:

Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.

Record adverse events and concomitant treatments; Prescription Vibrabot capsules or other treatment options. Visit 4 (Week 6 ±3 days) - Treatment Period 3

This visit includes:

Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day, take Vibrabot capsules on time or opt for other treatment plans; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks.

Record adverse events and concomitant treatments.

Visit 5 (Week 10±3 days) - Follow-up Period:

This visit includes:

Fill out the Daily Bowel Movement Questionnaire in the WeChat Official Account every day; Fill out the Constipation Symptom Self-Assessment Scale and Assessment Scale for Quality of Life with Constipation in the Official Account every 2 treatment weeks; Record adverse events and concomitant treatments.

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.

Primary outcomes:
measure: After treatment, whether the response rate of patients using the Vibrabot vibrating capsules alone reaches 50%.
timeFrame: At the end of the sixth week of treatment
Secondary outcomes:
measure: Proportion of constipated patients who use/do not use other constipation treatment methods
timeFrame: At the end of the sixth week of treatment
measure: Proportion of constipated patients who use/do not use other constipation treatment methods
timeFrame: at the end of the 4-week follow-up
measure: Proportion of patients with an average increase of ≥1 CSBMs per week compared to the baseline period
timeFrame: At the end of the sixth week of treatment
measure: Proportion of respondents with an average of ≥3 SBMs per week during the treatment period
timeFrame: At the end of the sixth week of treatment
measure: Proportion of subjects with ≥3 SBMs per week and an increase of ≥1 CSBMs during at least 4 weeks of treatment compared to baseline
timeFrame: At the end of the sixth week of treatment
measure: Proportion of patients with an average increase of ≥1 CSBMs per week during the follow-up phase compared to the baseline period;
timeFrame: At the end of the sixth week of treatment
measure: Proportion of patients with an average of ≥3 SBMs per week during the follow-up phase
timeFrame: at the end of the 4-week follow-up
measure: Proportion of patients with a reduction of ≥1 point in total Patient Assessment of Constipation Quality of Life questionnaire(PAC-QOL) scores after treatment compared to the baseline period
timeFrame: At the end of the sixth week of treatment
measure: Proportion of patients with a reduction of ≥1 point in total Patient Assessment of Constipation Symptom (PAC-SYM) scores after treatment compared to the baseline period
timeFrame: At the end of the sixth week of treatment
measure: Time of first use of laxative or enema after a course of vibrating capsule treatment (6 weeks)
timeFrame: After the end of the sixth week of treatment
Other outcomes:
measure: Proportion of constipated patients (including different constipation types, occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment.
timeFrame: At the end of the sixth week of treatment
measure: occupations, age groups, BMI, gender, and baseline treatment status) responding to vibrating capsule treatment.
timeFrame: at the end of the 4-week follow-up period.
Locations:
city: Shanghai
country: China
facility: Changhai hospital
Study officials:
affiliation: Changhai Hospital
name: Zhuan Liao, MD
role: STUDY_CHAIR
References:
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