Ignite Creation Date:
2024-05-11 @ 8:30 AM
Last Modification Date:
2024-10-26 @ 3:29 PM
Study NCT ID:
NCT06408883
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-10
First Post:
2024-05-07
Brief Title:
Effect of Vibration Capsule on Different Subtypes of Functional Constipation
Sponsor:
Changhai Hospital
Organization:
Changhai Hospital
Study Overview
Official Title:
A Prospective Cohort Study On the Efficacy of Vibrating Capsule For Different Subtypes of Chronic Functional Constipation
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 doctors 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
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 doctors 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
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 40 to 100 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 worlds 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 constipationHowever it remains unknown whether there are differences in treatment outcomes for patients with different subtypes of functional constipation
In this study we conducted a clinical study on patients with different subtypes of functional constipation to compare their therapeutic effects in patients with different subtypes
Patients will be divided into groups according to the results of colonic transit test balloon push-out test defecography and anorectal manometry
1 Inclusion Criteria
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
2 Exclusion Criteria
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
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 - BaselineScreening Period
This visit includes
The patient will sign an informed consent form Set the inclusionexclusion 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 43 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 103 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
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 worlds 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 constipationHowever it remains unknown whether there are differences in treatment outcomes for patients with different subtypes of functional constipation
In this study we conducted a clinical study on patients with different subtypes of functional constipation to compare their therapeutic effects in patients with different subtypes
Patients will be divided into groups according to the results of colonic transit test balloon push-out test defecography and anorectal manometry
1 Inclusion Criteria
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
2 Exclusion Criteria
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
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 - BaselineScreening Period
This visit includes
The patient will sign an informed consent form Set the inclusionexclusion 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 43 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 103 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None