Small/Large BowelNCT01433042
PillCam SB3 Capsule- Feasibility Study
A study testing capsule endoscopy in people with Small/Large Bowel, run by Medtronic - MITG at 4 sites in 4 countries.
Trial summary
Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Small/Large Bowel
- What is being tested?
- capsule endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 225 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Aug 2011to Oct 2012
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient age is ≥ 18 years old,
- Patients with history suggestive and /OR symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy,
- Patient and/or legal guardian is able and agrees to sign the Informed Consent Form
Who cannot join
- Patient has dysphagia,
- Patient is known or is suspected to suffer from intestinal obstruction,
- Patient has known previous stricture/obstruction of the SB or colon,
- Patient has a cardiac pacemakers or other implanted electro medical devices, 5. Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception,
- 6. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule, 7. Patient has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator, 8. Patient has any condition, which precludes compliance with study and/or device instructions, 9. Patient suffers from life threatening conditions, 10. Patient is currently participating in another clinical study, 11. Patient has known slow gastric emptying time
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
About this study
Official title: Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients
Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy.
Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small bowel disease.
Read more
Preparation for procedure will include 12 hours fasting prior to the capsule ingestion
Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion.
Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of capsule performance will be captured
Read the detailed description
- Purpose of study- To assess the performance of PillCam SB3 capsule in detecting small bowel lesions in patients
- Study design- Feasibility study
- Number of subjects- Up to 200
- Subject population- Patients with symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy
- No of centers- 4
- Duration of enrollment up to 12 months from IRB approval to enroll study patients
- Duration of follow-up 1 week after capsule procedure.
- Primary objectives To evaluate the performance of SB-3 system in patients as per physician questionnaire
- Conditions
- Small/Large Bowel
- Being tested
- capsule endoscopy
- Keywords
- small bowel disease
- Medical subject headings
- Cerebral Palsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsule endoscopyDevice
Also called CE
capsule endoscopy procedure
| Study group | Role | What they receive |
|---|---|---|
| capsule endoscopy | Experimental | Not described Receives: Device: capsule endoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians
precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians
Measured: up to 6 months from end of recruitment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2011 (estimated)
- Study startAug 2011
- Primary completionOct 2012
- Study completionOct 2012
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 Small/Large BowelStudies 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
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Samuel Adler, Prof, Principal investigator, Medtronic - MITG
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01433042
- Sponsor's protocol ID
- RD-304
- Status last verified
- Dec 2013
- First submitted
- 7 Sep 2011
- 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
- Assessment the Performance of PillCam SB3 Capsule in Detecting Small Bowel Lesions in Patients
- ClinicalTrials.gov ID
- NCT01433042
- Acronym / sponsor ID
- RD-304
- Conditions
- Small/Large Bowel
- Keywords
- small bowel disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Aug 2011
- Primary completion
- Oct 2012 (actual)
- Study completion
- Oct 2012 (actual)
- First posted
- 13 Sep 2011 (estimated)
- Results
- Posted 4 Feb 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study hypothesis: PillCam SB3 is a new capsule designed to provide an improved image quality, and improved SB and duodenum tissue coverage due to Adaptive Frame Rate (AFR) of 2-6 fps, which will create more images for evaluation, and therefore should improve diagnostic accuracy.
Proposed Design: to enroll up to 230 patients with symptoms suggesting the presence of small bowel disease.
Preparation for procedure will include 12 hours fasting prior to the capsule ingestion
Patients will undergo a standard capsule endoscopy. Patients will be allowed to drink clear liquids 2 hours post ingestion, and eat 4 hours post ingestion.
Diagnostic yield of the SB3 will be calculated The Physician's subjective assessment of capsule performance will be captured
Detailed description
- Purpose of study- To assess the performance of PillCam SB3 capsule in detecting small bowel lesions in patients
- Study design- Feasibility study
- Number of subjects- Up to 200
- Subject population- Patients with symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy
- No of centers- 4
- Duration of enrollment up to 12 months from IRB approval to enroll study patients
- Duration of follow-up 1 week after capsule procedure.
- Primary objectives To evaluate the performance of SB-3 system in patients as per physician questionnaire
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capsule endoscopy | Experimental | Device: capsule endoscopy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patient age is ≥ 18 years old,
- Patients with history suggestive and /OR symptoms suggestive of small bowel disease and whom are eligible and indicated for SB capsule endoscopy,
- Patient and/or legal guardian is able and agrees to sign the Informed Consent Form
Key exclusion criteria (5 listed)
- Patient has dysphagia,
- Patient is known or is suspected to suffer from intestinal obstruction,
- Patient has known previous stricture/obstruction of the SB or colon,
- Patient has a cardiac pacemakers or other implanted electro medical devices, 5. Women who are either pregnant or nursing at the time of screening, who intend to be during the study period, or are of child-bearing potential and do not practice medically acceptable methods of contraception,
- 6. Patient is expected to undergo MRI examination within 7 days after ingestion of the capsule, 7. Patient has had prior abdominal surgery of the gastrointestinal tract other than uncomplicated procedures that would be unlikely to lead to bowel obstruction based on the clinical judgment of the investigator, 8. Patient has any condition, which precludes compliance with study and/or device instructions, 9. Patient suffers from life threatening conditions, 10. Patient is currently participating in another clinical study, 11. Patient has known slow gastric emptying time
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 |
|---|---|---|
| capsule endoscopyAlso: CEcapsule endoscopy procedure | Device | capsule endoscopy |
Primary outcome
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians
Time frame: up to 6 months from end of recruitment
precentage of SB3 images that were graded as superior in image quality to SB2 by the physicians
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.
Samuel Adler, Prof principal investigator
Medtronic - MITG
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing capsule endoscopy in people with Small/Large Bowel, run by Medtronic - MITG at 4 sites in 4 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 3 inclusion and 5 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 4 sites in Israel, Romania, Spain, Sweden. 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?
Yes. Results are posted in the registry (first posted 4 Feb 2014). 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?
Precentage of SB3 Images That Were Graded as Superior in Image Quality to SB2 by the Physicians (time frame: up to 6 months from end of recruitment). 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.