Crohn's DiseasePhase 1/2NCT01631435
PillCam® Platform With the PillCam Crohn's Disease Capsule
A Phase 1/2 study testing Pillcam colon capsule and PillCam™ Prep Procedure and Ileocolonoscopy in people with Crohn's Disease, run by Medtronic - MITG at 1 site in United States.
Trial summary
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Crohn's Disease
- What is being tested?
- Pillcam colon capsule and PillCam™ Prep Procedure and Ileocolonoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2012to Feb 2014
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subject ages 18-75 years, inclusive
- Subject has known CD and signs and symptoms of active disease including one of the following:
- Chronic diarrhea
- Chronic abdominal pain
- Rectal bleeding
- Subject has at least one of the following within three months of enrollment:
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- Positive inflammatory marker (ESR, CRP, thrombocytosis, leukocytosis, fecal lactoferrin, fecal alpha-1 antitrypsin)
- Anemia (hemoglobin level below normal reference range)
- Hypoalbuminemia (albumin below normal reference range)
- Weight loss
- Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 90 days prior to enrollment.
- Subject agrees to sign consent form
Who cannot join
- Indeterminate Colitis
- Ulcerative Colitis
- Antibiotic Associated Colitis
- Stool positive for Ova \&Parasite and for Clostridium difficile toxin within 3 months of enrollment
- Other known infectious cause of increased symptoms
- Known history of intestinal obstruction or current obstructive symptoms, such as severe abdominal pain with accompanying nausea or vomiting, based on investigator judgment.
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- Definite long stricture seen on radiological exam.
- Non-steroidal anti-inflammatory drugs including Aspirin, (twice weekly or more) during the 4 weeks preceding enrollment
- Suspected GI stricture, followed by Pillcam Patency study or other imaging study that could not prove patency of the GI tract.
- Subject has had prior abdominal surgery of the gastrointestinal tract in the last 6 months, other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator.
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subjects with known or suspected delayed gastric emptying
- Subjects with known or suspected delayed Small bowel motility
- Subject suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions.
- Subject has Type I or Type II Diabetes.
- Subject has any allergy or other known contraindication to the medications used in the study.
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Women who are either pregnant or nursing at the time of screening, or are of child-bearing potential and do not practice medically acceptable methods of contraception.
- Concurrent participation in another clinical trial using any investigational drug or device.
- Subject suffers from a life threatening condition.
- Subject with a history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters.
Trial locations and contacts
1 site in 1 country.
United States1 site
IU School of Medicine - Gastroenterology
Indianapolis, Indiana
About this study
Official title: Evaluation of the PillCam® Platform With the PillCam Crohn's Disease Capsule in Visualization of Lesions in the Small Bowel and Colon That May Indicate Crohn's Disease
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
Read the detailed description
This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below:
Visit 1; Screening visit
- Informed consent process
- screening for eligibility to participate in the study
- Inclusion/exclusion criteria
- Small bowel patency test
- Demographic data
- Pregnancy test
- General medical history
Visit 2; PillCam® Crohn's capsule ingestion
- PillCam® CD bowel preparation
- Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)
- Ileocolonoscopy with intubation of terminal ileum
Follow up period (5-9 days following visit 2)
- CE Follow up telephone contac
- Conditions
- Crohn's Disease
- Being tested
- Pillcam colon capsule and PillCam™ Prep Procedure, Ileocolonoscopy
- Keywords
- All subjects will have evidence of active symptoms associated with Crohn's disease
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pillcam colon capsule and PillCam™ Prep ProcedureOther
PillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day.
IleocolonoscopyDevice
Conventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure
- Ileocolonoscopy with intubation of terminal ileum
| Study group | Role | What they receive |
|---|---|---|
| bowel prep regimen | Other | Each study subject will undergo a bowel preparation followed by a PillCam procedure. Receives: Other: Pillcam colon capsule and PillCam™ Prep Procedure; Device: Ileocolonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon
the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy.
The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy.
Each patient was classified as follows:
- Active Crohn's disease is likely
- Active Crohn's disease is NOT likely "Active Crohn's disease" included the followings lesions:
- Aphthous ulceration
- Ulcers (other than Aphthous)
- Bleeding
- Inflammatory stricture Lesions other than the above list were classified as "Non active Crohn's disease."
Measured: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startJun 2012
- Primary completionJan 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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 1/2
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Debbra Helper, MD, Principal investigator, Indiana University, Indianapolis , USA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01631435
- Sponsor's protocol ID
- MA-206
- Status last verified
- Mar 2015
- First submitted
- 28 Jun 2012
- Last updated
- 1 Aug 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the PillCam® Platform With the PillCam Crohn's Disease Capsule in Visualization of Lesions in the Small Bowel and Colon That May Indicate Crohn's Disease
- ClinicalTrials.gov ID
- NCT01631435
- Acronym / sponsor ID
- MA-206
- Conditions
- Crohn's Disease
- Keywords
- All subjects will have evidence of active symptoms associated with Crohn's disease
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jun 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 29 Jun 2012 (estimated)
- Results
- Posted 27 Mar 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a prospective, multi-center (up to 6 sites) study which aims to To establish the effectiveness of the PillCam Platform with the PillCam Crohn's capsule as demonstrated by visualizing the small bowel and colon in patients with active symptoms associated with Crohn's disease (CD).
Detailed description
This is a prospective, multi-center (up to 6 sites) study which aims to evaluate the diagnostic yield and safety of the PillCam Platform with the CD capsule in subjects with symptoms associated with Crohn's disease. All subjects to be enrolled in this study will have evidence of active symptoms associated with Crohn's disease. Each subject will be required to follow a bowel preparation regimen and will undergo the Crohn's Disease capsule endoscopy procedure and thereafter the ileocolonoscopy procedure on the same day. The ileocolonoscopy procedure may be done the following day per physician discretion. If the ileocolonoscopy procedure is done within 24 hours from the CE procedure, the subject will stay on clear liquid diet. Observations/ assessments to be conducted in the trial detailed in the sections below:
Visit 1; Screening visit
- Informed consent process
- screening for eligibility to participate in the study
- Inclusion/exclusion criteria
- Small bowel patency test
- Demographic data
- Pregnancy test
- General medical history
Visit 2; PillCam® Crohn's capsule ingestion
- PillCam® CD bowel preparation
- Capsule endoscopy Conventional ileocolonoscopy Examination (same day or within 24 hours)
- Ileocolonoscopy with intubation of terminal ileum
Follow up period (5-9 days following visit 2)
- CE Follow up telephone contac
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| bowel prep regimen | Other | Other: Pillcam colon capsule and PillCam™ Prep Procedure, Device: IleocolonoscopyEach study subject will undergo a bowel preparation followed by a PillCam procedure. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Subject ages 18-75 years, inclusive
- Subject has known CD and signs and symptoms of active disease including one of the following:
- Subject has at least one of the following within three months of enrollment:
- Proven patency by the Agile capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, performed within the 90 days prior to enrollment.
- Subject agrees to sign consent form
Key exclusion criteria (21 listed)
- Indeterminate Colitis
- Ulcerative Colitis
- Antibiotic Associated Colitis
- Stool positive for Ova \&Parasite and for Clostridium difficile toxin within 3 months of enrollment
- Other known infectious cause of increased symptoms
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 |
|---|---|---|
| Pillcam colon capsule and PillCam™ Prep ProcedurePillCam® Crhon capsule preparation will include a clear liquid diet and administration of a purgative sulfate-free polyethylene glycol electrolyte lavage (SF-ELS) solution (e.g. Nulytely) divided into two doses: the first dose on the evening before the exam and the 2nd dose on the morning of the exam day. | Other | bowel prep regimen |
| IleocolonoscopyConventional ileocolonoscopy Examination (same day or within 24 hours)of CE procedure • Ileocolonoscopy with intubation of terminal ileum | Device | bowel prep regimen |
Primary outcome
Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon
Time frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment
the primary outcome will be evalluated as follow: The number of subjects having active Crohn's disease in their terminal ileum and / or colon as detected by the PillCam Platform with the CD capsule and ileocolonoscopy. The analysis related to the primary endpoint was applied for the terminal ileum and colon only due to the limited access of ileocolonoscopy. Each patient was classified as follows: * Active Crohn's disease is likely * Active Crohn's disease is NOT likely "Active Crohn's disease" included the followings lesions: * Aphthous ulceration * Ulcers (other than Aphthous) * Bleeding * Inflammatory stricture Lesions other than the above list were classified as "Non active Crohn's disease."
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Debbra Helper, MD principal investigator
Indiana University, Indianapolis , USA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Pillcam colon capsule and PillCam™ Prep Procedure and Ileocolonoscopy in people with Crohn's Disease, run by Medtronic - MITG 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 12 inclusion and 21 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 1 Aug 2019. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Mar 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Per-subject Diagnostic Yield of the PillCam Platform With the CD Capsule Within the Terminal Ileum and Colon as Compared to the Ileocolonoscopy Diagnostic Yield Within the Terminal Ileum and Colon (time frame: All the end points and outcomes measures will be evaluated within 4 months from end of enrollment). 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 1 Aug 2019.