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Clinical study of Disposable Gastrointestinal Vibrating Capsule combined with polyethylene glycol to optimize bowel preparation for colonoscopy

Clinical study of Disposable Gastrointestinal Vibrating Capsule combined with polyethylene glycol to optimize bowel preparation for colonoscopy

Status
Recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400089466
Enrollment
Unknown
Registered
2024-09-09
Start date
2024-03-27
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colon diseases

Interventions

Group A (traditional procedure group):1500 ml of polyethylene glycol at 8 p.m. the day before the examination + 1500 ml of polyethylene glycol solution 4h before the colonoscopy.
Group B (Linaclotide group):1 capsule of Linaclotide was taken orally at 6:00 p.m. the day before the examination + 2000 ml of polyethylene glycol solution was taken orally in divided doses before the
Group C (vibrabot capsule group):1 vibrabot capsule was taken at 7 a.m. the day before the examination, and 2,000 ml of polyethylene glycol solution was taken in divided doses before the colonoscopy.

Sponsors

PLA Rocket Force Characteristic Medical Center
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 70 Years

Inclusion criteria

Inclusion criteria: 1)Age 18~70 years old, no gender limitation. 2)patients with outpatient and inpatient colonoscopy in the Department of Gastroenterology of the Rocket Force Characteristic Medical Center.

Exclusion criteria

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)People with severe depression and anxiety and severe acute gastrointestinal lesions. 8)People who had gastrointestinal surgery or a history of surgery that changed the structure of the gastrointestinal tract (except for appendectomy) or people who underwent gastrointestinal ESD in the past three months. 9)People with severe hemorrhoids (patients with grade III-IV hemorrhoids according to the Clinical Practice Guidelines for the Management of Hemorrhoids of the American Society of Colon and Rectal Surgeons). 10)People who plan to undergo MRI in the near future. 11)Pregnant or expectant women. 12)People with other conditions, so the investigator considers them not eligible for this study.

Design outcomes

Primary

MeasureTime frame
Intestinal cleanliness score;

Secondary

MeasureTime frame
Defecation;Comparison of comfort level of bowel preparation ;Comparison of entry and exit times for colonoscopy; Cecum arrival rate;

Countries

China

Contacts

Public ContactChangzheng Li

PLA Rocket Force Characteristic Medical Center

licz007@aliyun.com+86 189 1088 3642

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026