Last updated: April 8, 2024
Sponsor: Beijing Tsinghua Chang Gung Hospital
Overall Status: Active - Recruiting
Phase
N/A
Condition
Constipation
Treatment
polyethylene glycol
Vibrabot capsule
Clinical Study ID
NCT06364111
Vibrabot Capsule
Ages 18-85 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- People with moderate to severe functional constipation according to Rome IV criteria.
- People who agree to use appropriate medical methods of contraception from the timethey sign the ICF until the end of the treatment period (excluding women in a medicalsterilization status).
- People who had a colonoscopy within three years before screening and negative results,or their colonoscopy results are judged by the investigator as mild anomalies, but thecause of their constipation cannot be explained. If the colonoscopy report isunavailable, the study physician will determine if a colonoscopy is needed. If thesubjects undergo a colonoscopy after signing the ICF, they will not enter thetreatment period until their BMs return to the baseline level.
- People had colonic polyps and a polypectomy (except for endoscopic submucosaldissection (ESD)): Those with a polyp ≤1 cm can be enrolled one month after thepolypectomy; Those with a polyp >1 cm can be enrolled three months after thepolypectomy.
- People who consent to participate in this trial and can communicate with theinvestigator and can understand and comply with the relevant procedures andrequirements during the study (including completing study questionnaires on time,being treated and visited as scheduled, and undergoing relevant examinations), andvoluntarily sign the ICF.
Exclusion
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, andlesions with bleeding tendencies.
- People with dysphagia.
- Pregnant women or women with pregnancy plans in the next year.
- People with severe depression and anxiety and severe acute gastrointestinal lesions.
- People who had gastrointestinal surgery or a history of surgery that changed thestructure of the gastrointestinal tract (except for appendectomy) or people whounderwent gastrointestinal ESD in the past three months.
- People with severe hemorrhoids (patients with grade III-IV hemorrhoids according tothe Clinical Practice Guidelines for the Management of Hemorrhoids of the AmericanSociety of Colon and Rectal Surgeons).
- People who plan to undergo MRI in the near future.
- People with other conditions, so the investigator considers them not eligible for thisstudy.
Study Design
Total Participants: 45
Treatment Group(s): 2
Primary Treatment: polyethylene glycol
Phase:
Study Start date:
January 08, 2024
Estimated Completion Date:
August 30, 2025
Study Description
Connect with a study center
XuanJiang
Beijing, Beijing 102218
ChinaActive - Recruiting
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