Status:
COMPLETED
Efficacy and Safety of Vibrating Capsule in Patients With Functional Constipation
Lead Sponsor:
Changhai Hospital
Collaborating Sponsors:
Changhai Hospital, Naval Medical University, Shanghai, China.
Beijing Xiehe Hospital, Beijing 100000, China.
Conditions:
Functional Constipation
Gastrointestinal Disease
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
The safety and efficacy of vibrating capsule (VC) in promoting defecation by mechanical stimulation of the gastrointestinal walls have been elucidated in animal studies and pilot clinical studies. Our...
Detailed Description
This study was a multicentred, double-blind, placebo-controlled clinical trial to assess the safety and the effecacy of a newly developed gastrointestinal vibrating capsule (VC) in treating patients w...
Eligibility Criteria
Inclusion
- Male and female patients aged over 18 years and under 80 years;
- Patients who present with chronic constipation for more than 6 months and with SBM less than 3 times per week within recent 3 weeks and have at least one of the following symptoms for more than one-fourth (25%) during defecation:
- Straining;
- Lumpy or hard stools (bristol stool form (BSF scale 1\~2);
- Sensation of incomplete evacuation;
- Sensation of anorectal obstruction/blockage;
- Manual maneuvers to facilitate defecation. Note: The above criteria can only be applied during spontaneous defecation, including no taking of laxatives within 24 hours before defecation, etc.
- Organic diseases were not found by barium enema or colonoscopy in the past year.
- Insufficient criteria for irritable bowel syndrome.
Exclusion
- Patients who have contraindications to gastroscopy or colonoscopy;
- Patients under 18 years or over 80 years;
- Active vomiting;
- Patients with a permanent pacemaker (e.g. implantable cardioverter-defibrillator);
- Patients with any electronic/magnetic/mechanically controlled devices (e.g. sacral nerve stimulators, bladder stimulators);
- Patients with dysphagia, odynophagia or known swallowing disorder;
- Patients with known Zenker's diverticulum;
- Patients with suspected bowel obstruction or bowel perforation;
- Patients with prior bowel obstruction;
- Patients with gastroparesis or known gastric outlet obstruction;
- Patients with known Crohn's disease;
- Patients who are taking daily non-steroidal anti-inflammatory drugs (excluding prophylactic doses of aspirin) for more than six months;
- Patients who have received abdominopelvic radiotherapy treatment;
- Patients with a history of GI tract surgery (Billroth I, Billroth II, Oesophagectomy, gastrectomy or bariatric procedure);
- Patients who are pregnant or lactating;
- Patients with altered mental status that would limit their ability to swallow;
- Patients with allergy to conscious sedation, polyethylene glycol or metoclopramide;
- Patients unwilling to swallow the capsule;
- Patients with known dementia affecting ability to consent;
- Patients who have warning signs in recent years including abnormal weight loss(\>10% in recent 3 month), bloody stool (except hemorrhoids), infection, etc.;
- Other inappropriate situations determined by physicians.
Key Trial Info
Start Date :
November 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 30 2020
Estimated Enrollment :
107 Patients enrolled
Trial Details
Trial ID
NCT04671264
Start Date
November 14 2018
End Date
October 30 2020
Last Update
December 17 2020
Active Locations (1)
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1
Changhai Hospital
Shanghai, Shanghai Municipality, China, 200437