Chronic Inflammatory Small Bowel DiseasePIANONCT02742714
PillCam SBC System Functionality in Established and Suspected IBD Patients
A study testing PillCam SBC system in people with Chronic Inflammatory Small Bowel Disease and Crohn's Disease, run by Medtronic - MITG at 5 sites in 3 countries.
Trial summary
This clinical study is designed to evaluate the PillCam SBC system performance in 50 established or suspected inflammatory bowel disease (IBD) patients by visualizing and assessing their small and large bowel. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Inflammatory Small Bowel Disease, Crohn's Disease
- What is being tested?
- PillCam SBC system
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Jul 2016to Mar 2017
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ages 18-75 years, inclusive
- Patient has known crohn disease and/ or ulcerative colitis Or
- Patient suspected to have inflammatory bowel disease and suffers from either:
- Diarrhea for more than 6 weeks and/or
- Abdominal pain for more than 6 weeks and/or
- Extra-luminal manifestations of IBD including: erythema nodosum, pyoderma gangrenosum, arthritis, peri-anal disease, uveitis, aphthous stomatitis and
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- Suffers from at least one of the symptoms / lab abnormalities listed below:
- Positive inflammatory marker (ESR, C reactive protein (CRP), thrombocytosis, fecal lactoferrin, fecal calprotectin) within 3 months prior to enrollment
- Unexplained anemia (less than normal limits) within 3 months prior to enrollment
- Hypoalbuminemia (<3.5 g/dl) within 3 months of enrollment
- Positive IBD serology within 3 months of enrollment
- Recurrent Fevers
- Unexplained weight loss
- Gastro-intestinal bleeding including melena and/or hematochezia and/or fecal occult blood test (FOBT) positive.
- Chronic perianal disease (fistula, fissure, peri-rectal abscess)
- Abnormal imaging of Gastrointestinal (GI) tract (e.g. Magnetic resonance enterography (MRE)) suggestive of inflammatory bowel disease
- For known CD patients, proven patency by the patency capsule or another approach deemed clinically acceptable by the investigator, e.g. CT enterography, MRE performed within the 90 days prior to enrollment
- Patients agree to sign consent form
Who cannot join
- Antibiotic Associated Colitis
- Stool positive for Ova \&Parasite and for Clostridium difficile toxin within 3 months of enrollment
- Other known infectious cause of symptoms
- Known or suspected intestinal obstruction
- Non-steroidal anti-inflammatory drugs (twice weekly or more) during the 4 weeks preceding enrollment.
- Suspected or known GI stricture, followed by patency capsule study or other imaging study that could not prove patency of the GI tract
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- Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule
- Patient with known gastrointestinal motility disorders
- Subjects with known or suspected delayed gastric emptying
- Patient suffers from any condition, such as swallowing problems, which precludes compliance with study and/or device instructions
- Patient has any allergy or other known contraindication or intolerance to the medications used in the study
- Patient 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
- Patient suffers from a life threatening condition
- Patients with history or clinical evidence of renal disease and/or previous clinically significant laboratory abnormalities of renal function parameters
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Israel3 sites
Shaare Zedek Medical Center
Jerusalem, 91031
Sheba Medical Center
Ramat Gan, 52621
The Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239
About this study
Official title: Evaluation of PillCam SBC Capsule Endoscopy System Performance in Established and Suspected IBD Patients to Assess System Functionality by Visualizing and Assessing the Small Bowel and Colon
This clinical study is designed to evaluate the PillCam SBC system performance in 50 established or suspected inflammatory bowel disease (IBD) patients by visualizing and assessing their small and large bowel.
Read the detailed description
The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa.
Fifty established and suspected IBD patients (at least half of them with established crohn disease (CD)) with active or quiescent disease activity, aged 18 years and up, with no symptomatic stricture or known obstruction that would prevent capsule passage will be enrolled in up to 6 medical sites in Israel and Europe.
Patients will undergo bowel prep, followed by a PillCam SBC capsule examination. Patency capsule may precede PillCam SBC ingestion according to physician discretion.
The PillCam Software videos will be evaluated by local site reader following a Subjective Assessment Form fulfillment.
- Being tested
- PillCam SBC system
- 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 SBC systemDevice
Also called PillCam Endoscopy system
The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa.
| Study group | Role | What they receive |
|---|---|---|
| PillCam SBC | Experimental | The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa. Receives: Device: PillCam SBC system |
What is being measured
The primary outcome is the main question the study is designed to answer.
Successful SBC procedure in terms of video creation and report generation per training instructions
Success procedures are being measured. Only if both video and report will be created it will be defined as success.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2016 (estimated)
- Study startJul 2016
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Inflammatory Small Bowel 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Abraham Eliakim, Prof., Principal investigator, Sheba Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02742714
- Sponsor's protocol ID
- COVGIRD0546
- Acronym
- PIANO
- Status last verified
- Sep 2017
- First submitted
- 2 Mar 2016
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of PillCam SBC Capsule Endoscopy System Performance in Established and Suspected IBD Patients to Assess System Functionality by Visualizing and Assessing the Small Bowel and Colon
- ClinicalTrials.gov ID
- NCT02742714
- Acronym / sponsor ID
- PIANO / COVGIRD0546
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Jul 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 19 Apr 2016 (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.
This clinical study is designed to evaluate the PillCam SBC system performance in 50 established or suspected inflammatory bowel disease (IBD) patients by visualizing and assessing their small and large bowel.
Detailed description
The PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa.
Fifty established and suspected IBD patients (at least half of them with established crohn disease (CD)) with active or quiescent disease activity, aged 18 years and up, with no symptomatic stricture or known obstruction that would prevent capsule passage will be enrolled in up to 6 medical sites in Israel and Europe.
Patients will undergo bowel prep, followed by a PillCam SBC capsule examination. Patency capsule may precede PillCam SBC ingestion according to physician discretion.
The PillCam Software videos will be evaluated by local site reader following a Subjective Assessment Form fulfillment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PillCam SBC | Experimental | Device: PillCam SBC systemThe PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Patients ages 18-75 years, inclusive
- Patient has known crohn disease and/ or ulcerative colitis Or
- Patient suspected to have inflammatory bowel disease and suffers from either:
- Diarrhea for more than 6 weeks and/or
- Abdominal pain for more than 6 weeks and/or
Key exclusion criteria (16 listed)
- Antibiotic Associated Colitis
- Stool positive for Ova \&Parasite and for Clostridium difficile toxin within 3 months of enrollment
- Other known infectious cause of symptoms
- Known or suspected intestinal obstruction
- Non-steroidal anti-inflammatory drugs (twice weekly or more) during the 4 weeks preceding enrollment.
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 SBC systemAlso: PillCam Endoscopy systemThe PillCam SBC system to be tested in this study, is a new system composed of capsule, Data recorder and a new software Pillcam Desktop Software (version 9.0). The main features of the SBC capsule are panoramic field of view and adaptive frame rate customized for complete coverage of both small bowel and colonic mucosa. | Device | PillCam SBC |
Primary outcome
Successful SBC procedure in terms of video creation and report generation per training instructions
Time frame: 4 weeks
Success procedures are being measured. Only if both video and report will be created it will be defined as success.
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 19 Sep 2017.
- Individual participant dataSharing planned: No
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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.
Abraham Eliakim, Prof. principal investigator
Sheba Medical Center
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam SBC system in people with Chronic Inflammatory Small Bowel Disease and Crohn's Disease, run by Medtronic - MITG at 5 sites in 3 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 18 inclusion and 16 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 19 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Israel, Italy, Spain. 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.
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?
Successful SBC procedure in terms of video creation and report generation per training instructions (time frame: 4 weeks). 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 19 Sep 2017.