Ulcerative ColitisNCT01467609
PillCam Colon Capsule Endoscopy for Ulcerative Colitis
An observational study of Ulcerative Colitis, run by Shanghai Jiao Tong University School of Medicine.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Ulcerative Colitis
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jul 2009to Nov 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: academic hospital endoscopist of digestive department
Who may be able to join
- Adult patients (aged 18-70)
- Ulcerative Colitis history
- Suffering from symptoms such as hematochezia, diarrhea or abdominal pain
Who cannot join
- 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.
About this study
Official title: PillCam Colon Capsule Endoscopy Versus Conventional Colonoscopy for the Detection of the Severity and Extent of Ulcerative Colitis
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.
Read the detailed description
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
- Ulcerative Colitis
- Keywords
- Pillcam colon capsule endoscopy, conventional colonoscopy, ulcerative colitis, endoscopic manifestation, colonoscopy
- Medical subject headings
- Colitis, Ulcerative
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional
the severity of patients investigated by PCC endoscopy and conventional colonoscopy the extent of evolved lesions extent investigated by PCC endoscopy and conventional colonoscopy the safety of PCC endoscopy course (eg: adverse events during bowel preparation and the course; the completion rate)
Secondary outcomes (4)
the gastrointestinal transit time (transit time from ingestion to excretion), cecum arrival time (transit time from ingestion to the cecum), and colon residence time (transit time from the arrival in the cecum to excretion)
clinical data such as age, gender,chief complaint
the Mayo score of each case
the quality of colonic preparation
4 grades contain excellent, good, fair and poor
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2011 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionNov 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhizheng Ge, Shanghai Jiao Tong University School of Medicine
- Investigators
- zhi zheng Ge, MD. Ph.D, Principal investigator, Clinical Professor of Gastroenterology Department, Shanghai Renji Hospital; Director, Head of Digestive Endoscopy Department, Shanghai Renji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01467609
- Sponsor's protocol ID
- rjyyxhk2319
- Status last verified
- Nov 2011
- First submitted
- 20 Oct 2011
- Last updated
- 8 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PillCam Colon Capsule Endoscopy Versus Conventional Colonoscopy for the Detection of the Severity and Extent of Ulcerative Colitis
- ClinicalTrials.gov ID
- NCT01467609
- Acronym / sponsor ID
- rjyyxhk2319
- Conditions
- Ulcerative Colitis
- Keywords
- Pillcam colon capsule endoscopy, conventional colonoscopy, ulcerative colitis, endoscopic manifestation, colonoscopy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Nov 2010 (actual)
- First posted
- 8 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- academic hospital endoscopist of digestive department
Key inclusion criteria (3 listed)
- Adult patients (aged 18-70)
- Ulcerative Colitis history
- Suffering from symptoms such as hematochezia, diarrhea or abdominal pain
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional
the severity of patients investigated by PCC endoscopy and conventional colonoscopy the extent of evolved lesions extent investigated by PCC endoscopy and conventional colonoscopy the safety of PCC endoscopy course (eg: adverse events during bowel preparation and the course; the completion rate)
4 secondary outcomes
the gastrointestinal transit time (transit time from ingestion to excretion), cecum arrival time (transit time from ingestion to the cecum), and colon residence time (transit time from the arrival in the cecum to excretion)
clinical data such as age, gender,chief complaint
the Mayo score of each case
the quality of colonic preparation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
zhi zheng Ge, MD. Ph.D principal investigator
Clinical Professor of Gastroenterology Department, Shanghai Renji Hospital; Director, Head of Digestive Endoscopy Department, Shanghai Renji Hospital
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Shanghai Jiao Tong University School of Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the accuracy of PCC endoscopy in the survey of ulcerative colitis compared with conventional compared with conventional. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2011.