Ulcerative ColitisPhase 3NCT00145808
Wireless Capsule Endoscopy in Ulcerative Colitis
A Phase 3 study testing Given® Diagnostic System in people with Ulcerative Colitis, run by University of Chicago at 1 site in United States.
Trial summary
Based on the inaccuracies of the current classification scheme for inflammatory bowel disease (IBD), the failure of surgical pouches and the findings of retrospective observational trials to date, we hypothesize that a significant proportion of patients with UC will have small bowel involvement that will result in a… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- Given® Diagnostic System
- Type of treatment
- Medical device
- How many people
- 116 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2005to Nov 2008
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Inclusion criteria for the "disease" arm include a clinical impression of ulcerative colitis that includes assessment of the colon by colonoscopy and biopsy and assessment of the terminal ileum either by ileoscopy or by small bowel radiograph or enteroclysis. Subjects in the "control" arm will only be included if they do not carry the diagnosis of UC or CD, have not had previous gastric or small bowel surgery and are free of gastrointestinal symptoms including unexplained abdominal pain, diarrhea or gastrointestinal bleeding.
Who cannot join
- A known bowel obstruction, fistula or stricture, a permanent pacemaker and/or implantable defibrillator, history of a swallowing disorder, inability to provide informed consent, pregnancy, the use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) within the past 30 days, known celiac disease, known terminal ileal disease on ileoscopy and a history of occult or obscure gastrointestinal bleeding of unclear etiology. In menstruating females, a urine HCG will be performed on the day they arrive for the study (prior to ingestion of the capsule), if fourteen (14) days or more have elapsed since their last menstrual period. If subject reports they are menopausal, a urine HCG will be performed unless subject has had no menses during the past two years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prospective Controlled Assessment of Wireless Capsule Endoscopy (WCE) in Ulcerative Colitis (UC)
Based on the inaccuracies of the current classification scheme for inflammatory bowel disease (IBD), the failure of surgical pouches and the findings of retrospective observational trials to date, we hypothesize that a significant proportion of patients with UC will have small bowel involvement that will result in a change in diagnosis to CD or the recognition of a new phenotype of IBD. The aim of this study is to determine the prevalence of small bowel pathology in patients diagnosed with UC using WCE. This information will aid in the current efforts to re-classify IBD using improved endoscopic and imaging technologies, genetic information and serologic information.
Read the detailed description
Subjects will undergo both a blood draw and a wireless capsule endoscopy (WCE).
The blood draw will occur in the GI procedure unit on the day of subjects exam.
WCE: Subject will only consume a clear liquid diet after noon the day prior to the exam. No food or beverage consumption any after 10 PM on the day before examination. Not oral medications after 12 AMon the day of exam (8 hours before subject's exam).
Day of exam, subject will report to the endoscopy unit. At that time, subject will be prepared for examination by doctor who will apply a sensor array to the abdomen with adhesive sleeves. In addition, a waist belt device that holds the data recorder will be fitted to subject. Subjects will swallow the capsule endoscope. The capsule endoscope passes naturally through digestive tract while transmitting video images to the data recorder worn on the belt for approximately eight hours. At this point, subjects will be free to leave the University of Chicago hospital until they return eight hours later for disconnection of the recording equipment.
Two hours after ingestion of the capsule, subject will be able to resume a clear liquid diet. Four hours after the study's start time, subject will be able to resume a regular diet ( solid foods). At this time, subject will also be able to resume taking oral medications.
After eight hours, subject will return to the endoscopy suite (DCAM 6H) for disconnection of the recording equipment (sensor array, data recorder, and belt). The time that the capsule was ingested, eating and drinking times, and disconnection time as well as any discomfort subject experienced will be recorded.
Subject will be contacted 72 hours after the examination to confirm passage of the capsule. If they have not reported passage of the capsule with this time, subject will undergo an abdominal radiograph in order to determine whether or not the capsule has passed.
Subjects will be asked to identify a non-relative control (spouses are acceptable) within five years of their age and of similar background without Ulcerative Colitis. There is an Information Handout that participating subjects will give to friends interested in participating. If the subject does not find anyone, they may still participate in this research study. The study staff will try to find someone for them.
- Conditions
- Ulcerative Colitis
- Being tested
- Given® Diagnostic System
- Keywords
- Ulcerative colitis
- Medical subject headings
- Colitis, Ulcerative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Given® Diagnostic SystemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess the prevalence of small bowel abnormalities in UC patients compared to controls.
Secondary outcomes (1)
Ensure safety of subjects by confirming passage of the capsule.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2005 (estimated)
- Study startJun 2005
- Primary completionJun 2007
- Study completionNov 2008
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.
- More trials run by University of ChicagoThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 3
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 116 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Chicago
- Sponsor type
- University, hospital or other
- Collaborators
- Prometheus Laboratories, American College of Gastroenterology
- Responsible party
- Sponsor
- Investigators
- David Rubin, MD, Principal investigator, University of Chicago
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00145808
- Sponsor's protocol ID
- 13215A
- Status last verified
- Sep 2013
- First submitted
- 1 Sep 2005
- Last updated
- 5 Sep 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Controlled Assessment of Wireless Capsule Endoscopy (WCE) in Ulcerative Colitis (UC)
- ClinicalTrials.gov ID
- NCT00145808
- Acronym / sponsor ID
- 13215A
- Conditions
- Ulcerative Colitis
- Keywords
- Ulcerative colitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 116 participants (estimated)
- Lead sponsor
- University of ChicagoUniversity, hospital or other
- Collaborators
- Prometheus Laboratories, American College of Gastroenterology
- Study start
- Jun 2005
- Primary completion
- Jun 2007 (actual)
- Study completion
- Nov 2008 (actual)
- First posted
- 5 Sep 2005 (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.
Based on the inaccuracies of the current classification scheme for inflammatory bowel disease (IBD), the failure of surgical pouches and the findings of retrospective observational trials to date, we hypothesize that a significant proportion of patients with UC will have small bowel involvement that will result in a change in diagnosis to CD or the recognition of a new phenotype of IBD. The aim of this study is to determine the prevalence of small bowel pathology in patients diagnosed with UC using WCE. This information will aid in the current efforts to re-classify IBD using improved endoscopic and imaging technologies, genetic information and serologic information.
Detailed description
Subjects will undergo both a blood draw and a wireless capsule endoscopy (WCE).
The blood draw will occur in the GI procedure unit on the day of subjects exam.
WCE: Subject will only consume a clear liquid diet after noon the day prior to the exam. No food or beverage consumption any after 10 PM on the day before examination. Not oral medications after 12 AMon the day of exam (8 hours before subject's exam).
Day of exam, subject will report to the endoscopy unit. At that time, subject will be prepared for examination by doctor who will apply a sensor array to the abdomen with adhesive sleeves. In addition, a waist belt device that holds the data recorder will be fitted to subject. Subjects will swallow the capsule endoscope. The capsule endoscope passes naturally through digestive tract while transmitting video images to the data recorder worn on the belt for approximately eight hours. At this point, subjects will be free to leave the University of Chicago hospital until they return eight hours later for disconnection of the recording equipment.
Two hours after ingestion of the capsule, subject will be able to resume a clear liquid diet. Four hours after the study's start time, subject will be able to resume a regular diet ( solid foods). At this time, subject will also be able to resume taking oral medications.
After eight hours, subject will return to the endoscopy suite (DCAM 6H) for disconnection of the recording equipment (sensor array, data recorder, and belt). The time that the capsule was ingested, eating and drinking times, and disconnection time as well as any discomfort subject experienced will be recorded.
Subject will be contacted 72 hours after the examination to confirm passage of the capsule. If they have not reported passage of the capsule with this time, subject will undergo an abdominal radiograph in order to determine whether or not the capsule has passed.
Subjects will be asked to identify a non-relative control (spouses are acceptable) within five years of their age and of similar background without Ulcerative Colitis. There is an Information Handout that participating subjects will give to friends interested in participating. If the subject does not find anyone, they may still participate in this research study. The study staff will try to find someone for them.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inclusion criteria for the "disease" arm include a clinical impression of ulcerative colitis that includes assessment of the colon by colonoscopy and biopsy and assessment of the terminal ileum either by ileoscopy or by small bowel radiograph or enteroclysis. Subjects in the "control" arm will only be included if they do not carry the diagnosis of UC or CD, have not had previous gastric or small bowel surgery and are free of gastrointestinal symptoms including unexplained abdominal pain, diarrhea or gastrointestinal bleeding.
Key exclusion criteria (1 listed)
- A known bowel obstruction, fistula or stricture, a permanent pacemaker and/or implantable defibrillator, history of a swallowing disorder, inability to provide informed consent, pregnancy, the use of aspirin or non-steroidal anti-inflammatory drugs (NSAIDs) within the past 30 days, known celiac disease, known terminal ileal disease on ileoscopy and a history of occult or obscure gastrointestinal bleeding of unclear etiology. In menstruating females, a urine HCG will be performed on the day they arrive for the study (prior to ingestion of the capsule), if fourteen (14) days or more have elapsed since their last menstrual period. If subject reports they are menopausal, a urine HCG will be performed unless subject has had no menses during the past two years.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Given® Diagnostic System | Device | – |
Primary outcome
Assess the prevalence of small bowel abnormalities in UC patients compared to controls.
1 secondary outcome
Ensure safety of subjects by confirming passage of the capsule.
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 5 Sep 2013.
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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.
David Rubin, MD principal investigator
University of Chicago
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Given® Diagnostic System in people with Ulcerative Colitis, run by University of Chicago at 1 site in United States.
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 1 inclusion and 1 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 5 Sep 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Assess the prevalence of small bowel abnormalities in UC patients compared to controls.. 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 5 Sep 2013.