Crohn's DiseasePhase 3NCT00596700
Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study
A Phase 3 study testing Given® Diagnostic System including PillCamTM SB Capsules in people with Crohn's Disease, run by Rabin Medical Center at 4 sites in 2 countries.
Trial summary
The Study 1. Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score 2. Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria 3. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Given® Diagnostic System including PillCamTM SB Capsules
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 4 sitesin 2 countries
- Study dates
- Jan 2007to Jan 2012
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients 18 years or older and not greater than 80 years suffer from Crohn's Disease of the small bowel, documented by clinical, endoscopical, histopathological and radiological parameters, in any activity stage iof the disease and any treatment
- Documented written Informed Consent
Who cannot join
- Subject suffers from swallowing difficulties
- Female subject is pregnant or nursing (in case of necessary small bowel series a pregnancy test has to be performed prior to the test)
- Subject is known to suffer from intestinal obstruction
- Subject has a cardiac pacemakers or other implanted electro medical devices
- Patients with more than 40% small bowel resect
- Subject has any condition, which precludes compliance with study and/or device instructions
Show all 9Show fewer
- Subject suffers from life threatening conditions
- Subject is currently participating in another clinical study
- Subject with colonic involvement of Crohn's disease
Trial locations and contacts
4 sites in 2 countries.
4 sites in 2 countries
Israel3 sites
Hillel Jafa Medical Center
Hadera
Rabin Medical Center, Beilinson Hospital, Tel Aviv University
Petah Tikva, 49100
Asaf Harofe Medical Center
Zrifin
About this study
The Study
- Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score
- Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria
- Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP
- Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire
- Capsule exam is performed
- CD of de-identified is made at the study site.
- Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails
- CDs are copied
- CDs of study patients are provided to blinded readers
Read the detailed description
The Niv score was devised to measure mucosal disease activity in Crohn's disease using capsule endoscopy. This scoring index is based on inflammatory score parameters: Erythema, hyperemia, edema, denudation, nodularity, apthae, erosion, ulcer, bleeding), extent score: Focal, patchy, diffuse, and stricture score: single-passed, multiple-passed, obstruction. The higher the score, the more involvement is observed. The advantage of this index is that it actually measures disease activity and not symptoms in an easy non-invasive manner. For assessing Crohn's disease, mucosal healing can be directly seen and if there is no mucosal disease there can be no symptoms secondary to inflammatory bowel disease. The subjective nature of disease activity indices is avoided, as is the problem of disease without symptoms. It is envisioned that the Niv score could diagnose Crohn's disease (excluding normally occurring mucosal breaks), identify NSAID damage, measure disease activity / severity, measure drug response for clinical trials and in practice, and guide medical management for the patient's with small bowel Crohn's disease.
This study will measure the Niv score against CDAI. Since capsule endoscopy assesses mucosal disease and not symptoms it is not envisioned that the Niv score will perfectly correlate with the Harvey-Bradshaw score. It is envisioned that the Niv score will have the same direction. Both of these indices will be determined as part of a multicenter trial. The trial design is outlined below.
The Study
- Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score
- Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria
- Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP
- Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire
- Capsule exam is performed
- CD of de-identified is made at the study site.
- Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails
- CDs are copied
- CDs of study patients are provided to blinded readers Scoring sheets will be provided to readers - see addendum A
- Readers will score the CDs and return the scoring sheets to the principal investigator
- Data is collated and analyzed
- Conditions
- Crohn's Disease
- Being tested
- Given® Diagnostic System including PillCamTM SB Capsules
- Keywords
- Capsule endoscopy, Crohn's disease, IBD, Activity score, Small bowel, Crohn's disease of the small bowel in any stage, Recruiting
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Given® Diagnostic System including PillCamTM SB CapsulesDevice
Also called PillCam™SB capsule (Given Imaging Ltd, Yoqneam, Israel)
Device for detection of pathologies as a tool in the diagnosis of gastrointestinal disorders.
An ingestible,disposable video camera that transmits high quality images of the small intestinal mucosa
| Study group | Role | What they receive |
|---|---|---|
| Device | Experimental | Patient preparation procedure will be done according to chapter 4 in the Given Diagnostic System user manual. In brief: to drink only clear liquids beginning 12:00 noon the day before.at least 8 hours (since 12:00 PM) fast prior to the procedure. Patient will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion.
Eight hours post ingestion, data recorder will be removed and the patient will be dismissed.
A local experienced reader will review the RAPID video to determine the diagnosis blinded to the results of the standard workup procedures, and to each other results. Results will be recorded in the case report forms. A decoded video will be transferred to the principal investigator for reevaluation Receives: Device: Given® Diagnostic System including PillCamTM SB Capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
This prospective study is aimed to evaluate the correlation of capsule endoscopy CECDAI with the CDAI (accepted clinical index) and IBDQ (quality of life questionnaire) in patients suffering from small-bowel Crohn's disease
Measured: Two years
Secondary outcomes (1)
Capsule endoscopy investigation and crohn's disease outcome
Measured: Two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jan 2008 (estimated)
- Study startJan 2007
- Primary completionJan 2012
- Study completionJan 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Crohn's DiseaseStudies 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
- Interventional
- Phase
- Phase 3
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- US Department of Veterans Affairs, Rambam Health Care Campus, Assaf-Harofeh Medical Center, Hillel Yaffe Medical Center, University of Athens, University of Magdeburg
- Responsible party
- Principal investigator, Yaron Niv, Rabin Medical Center
- Investigators
- Yaron Niv, MD, AGAF, Principal investigator, RMC, Tel Aviv University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00596700
- Sponsor's protocol ID
- CECDAI-2006
- Status last verified
- Apr 2014
- First submitted
- 8 Jan 2008
- Last updated
- 29 Apr 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Capsule Endoscopy Crohn's Disease Activity Index - Validation Multi Center Study
- ClinicalTrials.gov ID
- NCT00596700
- Acronym / sponsor ID
- CECDAI-2006
- Conditions
- Crohn's Disease
- Keywords
- Capsule endoscopy, Crohn's disease, IBD, Activity score, Small bowel, Crohn's disease of the small bowel in any stage, Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Collaborators
- US Department of Veterans Affairs, Rambam Health Care Campus, Assaf-Harofeh Medical Center, Hillel Yaffe Medical Center, University of Athens, University of Magdeburg
- Study start
- Jan 2007
- Primary completion
- Jan 2012 (actual)
- Study completion
- Jan 2012 (actual)
- First posted
- 17 Jan 2008 (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.
The Study
- Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score
- Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria
- Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP
- Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire
- Capsule exam is performed
- CD of de-identified is made at the study site.
- Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails
- CDs are copied
- CDs of study patients are provided to blinded readers
Detailed description
The Niv score was devised to measure mucosal disease activity in Crohn's disease using capsule endoscopy. This scoring index is based on inflammatory score parameters: Erythema, hyperemia, edema, denudation, nodularity, apthae, erosion, ulcer, bleeding), extent score: Focal, patchy, diffuse, and stricture score: single-passed, multiple-passed, obstruction. The higher the score, the more involvement is observed. The advantage of this index is that it actually measures disease activity and not symptoms in an easy non-invasive manner. For assessing Crohn's disease, mucosal healing can be directly seen and if there is no mucosal disease there can be no symptoms secondary to inflammatory bowel disease. The subjective nature of disease activity indices is avoided, as is the problem of disease without symptoms. It is envisioned that the Niv score could diagnose Crohn's disease (excluding normally occurring mucosal breaks), identify NSAID damage, measure disease activity / severity, measure drug response for clinical trials and in practice, and guide medical management for the patient's with small bowel Crohn's disease.
This study will measure the Niv score against CDAI. Since capsule endoscopy assesses mucosal disease and not symptoms it is not envisioned that the Niv score will perfectly correlate with the Harvey-Bradshaw score. It is envisioned that the Niv score will have the same direction. Both of these indices will be determined as part of a multicenter trial. The trial design is outlined below.
The Study
- Prospective trial of the Niv score validating score against known activity indices - see addendum A for Niv score
- Known Crohn's disease patients undergoing capsule endoscopy are identified - see addendum B for inclusion/exclusion criteria
- Prior to capsule exam, temperature is taken, height and weight measured, bloods are drawn for albumin, ESR, HCT, CRP
- Prior to capsule exam, symptom/exam questionnaire is completed - see addendum C for questionnaire
- Capsule exam is performed
- CD of de-identified is made at the study site.
- Landmarks are confirmed and the small bowel transit time is divided into 2 and labeled on thumbnails
- CDs are copied
- CDs of study patients are provided to blinded readers Scoring sheets will be provided to readers - see addendum A
- Readers will score the CDs and return the scoring sheets to the principal investigator
- Data is collated and analyzed
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Device | Experimental | Device: Given® Diagnostic System including PillCamTM SB CapsulesPatient preparation procedure will be done according to chapter 4 in the Given Diagnostic System user manual. In brief: to drink only clear liquids beginning 12:00 noon the day before.at least 8 hours (since 12:00 PM) fast prior to the procedure. Patient will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion. Eight hours post ingestion, data recorder will be removed and the patient will be dismissed. A local experienced reader will review the RAPID video to determine the diagnosis blinded to the results of the standard workup procedures, and to each other results. Results will be recorded in the case report forms. A decoded video will be transferred to the principal investigator for reevaluation |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients 18 years or older and not greater than 80 years suffer from Crohn's Disease of the small bowel, documented by clinical, endoscopical, histopathological and radiological parameters, in any activity stage iof the disease and any treatment
- Documented written Informed Consent
Key exclusion criteria (9 listed)
- Subject suffers from swallowing difficulties
- Female subject is pregnant or nursing (in case of necessary small bowel series a pregnancy test has to be performed prior to the test)
- Subject is known to suffer from intestinal obstruction
- Subject has a cardiac pacemakers or other implanted electro medical devices
- Patients with more than 40% small bowel resect
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 including PillCamTM SB CapsulesAlso: PillCam™SB capsule (Given Imaging Ltd, Yoqneam, Israel)Device for detection of pathologies as a tool in the diagnosis of gastrointestinal disorders. An ingestible,disposable video camera that transmits high quality images of the small intestinal mucosa | Device | Device |
Primary outcome
This prospective study is aimed to evaluate the correlation of capsule endoscopy CECDAI with the CDAI (accepted clinical index) and IBDQ (quality of life questionnaire) in patients suffering from small-bowel Crohn's disease
Time frame: Two years
1 secondary outcome
Capsule endoscopy investigation and crohn's disease outcome
Time frame: Two years
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 29 Apr 2014.
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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.
Yaron Niv, MD, AGAF principal investigator
RMC, Tel Aviv University
4 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Given® Diagnostic System including PillCamTM SB Capsules in people with Crohn's Disease, run by Rabin Medical Center at 4 sites in 2 countries.
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 2 inclusion and 9 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 29 Apr 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Israel, Ireland. 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?
This prospective study is aimed to evaluate the correlation of capsule endoscopy CECDAI with the CDAI (accepted clinical index) and IBDQ (quality of life questionnaire) in patients suffering from small-bowel Crohn's disease (time frame: Two years). 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 29 Apr 2014.