PillCam Colon Capsule Endoscopy for Ulcerative Colitis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Pillcam colon capsule (PCC) endoscopy is a novel strategy tool to inspect colon mucosa. The aim of the present study is to evaluate if PCC endoscopy is able to precisely investigate patients with ulcerative colitis and reach high consistency to conventional colonoscopy.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Symptomatic patients with confirmed ulcerative colitis (UC) were enrolled in this prospective single-center study. No sooner had patients gone through Pillcam colon capsule (PCC) endoscopy solution than they got conventional colonoscopy which is recognized as the "gold standard" examination technique. The extent of mucosal damage and inflammatory lesions during both modalities were recorded for comparison. In addition, the regimen of bowel preparation, completion rate, colonic cleanliness, compliance or adverse events were analyzed.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Ulcerative Colitis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Adult patients (aged 18-70)
* Ulcerative Colitis history
* Suffering from symptoms such as hematochezia, diarrhea or abdominal pain

Exclusion Criteria

* Patients with a high risk for capsule retention (such as intestinal diverticula, acute abdominal pain without regular defecation indicating intestinal obstruction or a history of abdominal operation or intestinal reconstructed operation),
* Patients allergic to sodium phosphate or polyethylene glycol (PEG) solution,
* Patients with a history of Crohn's disease
* Patients with serious systematic diseases such as congestive heart failure, renal failure or severe liver disease.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Zhizheng Ge

Shanghai Institute of Digestive Disease，Renji Hospital, Shanghai Jiao Tong University School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

zhi zheng Ge, MD. Ph.D

Role: PRINCIPAL_INVESTIGATOR

Clinical Professor of Gastroenterology Department, Shanghai Renji Hospital; Director, Head of Digestive Endoscopy Department, Shanghai Renji Hospital

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

rjyyxhk2319

Identifier Type: -

Identifier Source: org_study_id