Status:
COMPLETED
The Efficacy of Long-Course Treatment Using Vibrating Capsules for Chronic Constipation
Lead Sponsor:
Beijing Tsinghua Chang Gung Hospital
Conditions:
Chronic Functional Constipation
Eligibility:
All Genders
18-85 years
Phase:
NA
Brief Summary
This is a single-center trial. It enrolled nine 18- to 85-year-old patients with chronic constipation to evaluate the efficacy of long-course treatment by using vibrating capsule (VC).
Detailed Description
This study was a single-center prospective, single-arm exploratory clinical trial. If a subject signs an Ethics Committee (EC)-approved study informed consent (ICF) that meets the inclusion criteria a...
Eligibility Criteria
Inclusion
- 18 to 85-year-old men and women.
- Patients with symptoms of constipation in the six months prior to treatment, with less than three complete spontaneous bowel movements (CSBM) per week over the last three months, along with at least one of the following symptoms in at least 25% of bowel movements: Straining during defecation; Lumpy or hard stools (Bristol stool types 1-2) in at least 25% of bowel movements; A sensation of incomplete evacuation in at least 25% of bowel movements; A sensation of anorectal obstruction/blockage in at least 25% of bowel movements; Manual maneuvers to facilitate defecation (e.g., digital evacuation, pelvic floor support) in at least 25% of bowel movements. Loose stools are rarely present without the use of laxatives; insufficient criteria for irritable bowel syndrome Criteria fulfilled for the last three months with symptom onset at least six months prior to diagnosis.
- Patients with constipation not caused by organic disease based on medical history and previous medical records.
- Patients who agree to participate in the trial and voluntarily sign the informed consent form.
Exclusion
- Patients who are not eligible for surgery or those who refuse any abdominal surgery.
- Patients with known or suspected gastrointestinal obstruction, stenosis, diverticula, bleeding, deformities, or fistulas.
- Patients allergic to polymer materials.
- Patients with cardiac pacemakers or gastrointestinal pacemakers.
- Patients with abdominal aortic aneurysm, gastrointestinal vascular diseases, ulcers, or bleeding tendencies.
- Patients with swallowing disorders.
- Patients with severe depression or anxiety, or severe acute gastrointestinal diseases.
- Patients with history of gastrointestinal surgery or surgeries altering gastrointestinal structure (excluding appendectomy) or patients who underwent gastrointestinal endoscopic submucosal dissection (ESD) in the past three months.
- Patients with severe hemorrhoids (grade 3-4 as defined by the American Society of Colon and Rectal Surgeons guidelines).
- Patients planning to undergo magnetic resonance imaging (MRI) in the near future.
- Pregnant women or planning to become pregnant.
- Any other conditions deemed unsuitable for participation by the investigators.
Key Trial Info
Start Date :
July 28 2023
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2023
Estimated Enrollment :
9 Patients enrolled
Trial Details
Trial ID
NCT06553664
Start Date
July 28 2023
End Date
December 2 2023
Last Update
August 19 2024
Active Locations (1)
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1
XuanJiang
Beijing, Beijing Municipality, China, 102218