Intestinal DiseaseNCT01787825
Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease
A study testing PillCam SB2 capsule and CapsoCam SV-1 in people with Intestinal Disease and Inflammatory Bowel Disease, run by Capso Vision, Inc. at 7 sites in 2 countries.
Trial summary
The purpose of this study is to compare the clinical findings involving the small bowel obtained with the Capso Vision Video Capsule Device to those results obtained with the PillCam SB2. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Disease, Inflammatory Bowel Disease, Crohn Disease
- What is being tested?
- PillCam SB2 capsule and CapsoCam SV-1
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 121 participants
- Where
- 7 sitesin 2 countries
- Study dates
- May 2012to Feb 2016
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female between 18 to 85 years of age (inclusive).
- Willing and able to provide written informed consent.
- Subjects with suspected small bowel disease who are referred for capsule endoscopy. Suspected small bowel disease includes suspected small bowel bleeding (including obscure gastrointestinal bleed), suspected or established Crohn's Disease [should have had patency capsule, CT or MR enterography before entry], suspected or known celiac disease, suspected small bowel tumor or familial polyposis syndrome.
- If subject was referred for capsule endoscopy (CE) for identification of occult GI bleeding, has the subject undergone a non-diagnostic esophagoduodenoscopy and colonoscopy as part of their evaluation, OR has the subject had continued bleeding requiring transfusion since the initial evaluation, OR does the subject have the following hematocrit values <31% in males or <28% in females.
Who cannot join
- Subjects who had a prior negative capsule endoscopy (within 1 year of study).
- Known or suspected obstruction or stricture unless patency capsule confirms patency.
- Known or suspected gastrointestinal perforation.
- Known or suspected small bowel diverticuli.
- Known swallowing disorder or the inability or unwillingness to swallow pills.
- Radiation or chemotherapy induced enteritis.
Show all 19Show fewer
- History of Zenker's or known duodenal or jejunal diverticula.
- Isolated diarrhea or isolated abdominal pain without alarm signs or symptoms
- Subjects who are high risk for undergoing surgical interventions (i.e., to CONFIDENTIAL CapsoVision Protocol SV-1 Revision: October 17, 2011 7 remove the capsule when capsule retention occurs).
- Subjects with DNR/DNI "do not resuscitate/do not intubate" status.
- Known or suspected gastrointestinal dysmotility.
- Presence of cardiac pacemaker, implanted defibrillator or other electromedical implant.
- History of skin reaction to adhesives.
- Subjects who in the Investigator's opinion should not consume the 2L GoLytely and 10 mg bisacodyl study drugs, because it could pose a significant additional risk to the subject because of the subject's medical condition.
- Subjects who are scheduled for an MRI within 30 days of the last study visit.
- Pregnancy; females of childbearing potential must have a negative urine pregnancy test at screening.
- Prisoners.
- Mental and/or physical condition precluding compliance with the study and/or device instructions.
- Participation in another clinical study within past 30 days.
Trial locations and contacts
7 sites in 2 countries.
7 sites in 2 countries
United States6 sites
Medical University of South Carolina
Charleston, South Carolina, 29425
UT Southwestern Medical Center
Dallas, Texas, 75390
Ziad Younes, MD
Germantown, Tennessee, 38138
Gastro Health
Miami, Florida, 33173
Shabana F. Pasha, MD
Scottsdale, Arizona, 85259
University of Massachusetts, Worcester
Worcester, Massachusetts, 01655
Canada1 site
Pacific Gastroenterology Associates GI Research Institute
Vancouver, British Columbia, V6Z 2K5
About this study
The purpose of this study is to compare the clinical findings involving the small bowel obtained with the Capso Vision Video Capsule Device to those results obtained with the PillCam SB2.
Read the detailed description
This is a prospective, randomized, comparative multi-center site study. The study will be conducted at 5 to 10 clinical sites. Up to 120 subjects will be enrolled in the study in order to obtain complete endoscopic results involving at least 98 subjects.
- Being tested
- PillCam SB2 capsule, CapsoCam SV-1
- Keywords
- intestinal disease, inflammatory bowel disease, crohn disease, ulcer, celiac disease, angioectasia, polyp
- Medical subject headings
- Intestinal Diseases, Inflammatory Bowel Diseases, Crohn Disease, Ulcer, Celiac Disease, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PillCam SB2 capsuleDevice
Also called capsule endoscopy system
Capsule Endoscopy system
CapsoCam SV-1Device
Also called Capsule endoscopy
Capsule endoscopy
| Study group | Role | What they receive |
|---|---|---|
| PillCam SB2 then CapsoCam SV-1 | Other | PillCam SB2 capsule then CapsoCam SV-1 capsule Receives: Device: PillCam SB2 capsule; Device: CapsoCam SV-1 |
| CapsoCam SV-1 then PillCam SB2 | Other | CapsoCam SV-1 capsule then PillCam SB2 capsule Receives: Device: PillCam SB2 capsule; Device: CapsoCam SV-1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Normal vs Abnormal, Overall Impression
The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.
Measured: Study Completion
Secondary outcomes (3)
Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2
Total transit time, was determined the time the 1st Duodenal image to the 1st cecal or IC Valve image as determined by the readers.
Measured: Study Completion
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Comparison of Diagnostic Yield of CapsoCam SV-1 as compared to PillCam SB: Proportion of primary diagnostic yields based upon the result of 2 out of 3 readers in agreement or the consensus group result.
Measured: Study Completion
Preference Between CapsoCam SV-1 and PillCam SB2
Subject preference between CapsoCam SV-1 and PillCam SB2 based on pill preference questionnaire administered to subjects
Measured: Study Completion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2013 (estimated)
- Study startMay 2012
- Primary completionApr 2015
- Study completionFeb 2016
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 Intestinal 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
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 121 participants (actual)
Sponsor and investigators
- Lead sponsor
- Capso Vision, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shabana F Pasha, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01787825
- Sponsor's protocol ID
- Capso Vision SV-1
- Status last verified
- Mar 2017
- First submitted
- 2 May 2012
- Last updated
- 10 May 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Capso Vision SV-1 to PillCam SB2 in the Evaluation of Subjects With Suspected Small Bowel Disease
- ClinicalTrials.gov ID
- NCT01787825
- Acronym / sponsor ID
- Capso Vision SV-1
- Keywords
- intestinal disease, inflammatory bowel disease, crohn disease, ulcer, celiac disease, angioectasia, polyp
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 121 participants (actual)
- Lead sponsor
- Capso Vision, Inc.Industry (pharma, biotech, devices)
- Study start
- May 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Feb 2016 (actual)
- First posted
- 11 Feb 2013 (estimated)
- Results
- Posted 10 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the clinical findings involving the small bowel obtained with the Capso Vision Video Capsule Device to those results obtained with the PillCam SB2.
Detailed description
This is a prospective, randomized, comparative multi-center site study. The study will be conducted at 5 to 10 clinical sites. Up to 120 subjects will be enrolled in the study in order to obtain complete endoscopic results involving at least 98 subjects.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PillCam SB2 then CapsoCam SV-1 | Other | Device: PillCam SB2 capsule, Device: CapsoCam SV-1PillCam SB2 capsule then CapsoCam SV-1 capsule |
| CapsoCam SV-1 then PillCam SB2 | Other | Device: PillCam SB2 capsule, Device: CapsoCam SV-1CapsoCam SV-1 capsule then PillCam SB2 capsule |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Male or female between 18 to 85 years of age (inclusive).
- Willing and able to provide written informed consent.
- Subjects with suspected small bowel disease who are referred for capsule endoscopy. Suspected small bowel disease includes suspected small bowel bleeding (including obscure gastrointestinal bleed), suspected or established Crohn's Disease [should have had patency capsule, CT or MR enterography before entry], suspected or known celiac disease, suspected small bowel tumor or familial polyposis syndrome.
- If subject was referred for capsule endoscopy (CE) for identification of occult GI bleeding, has the subject undergone a non-diagnostic esophagoduodenoscopy and colonoscopy as part of their evaluation, OR has the subject had continued bleeding requiring transfusion since the initial evaluation, OR does the subject have the following hematocrit values <31% in males or <28% in females.
Key exclusion criteria (19 listed)
- Subjects who had a prior negative capsule endoscopy (within 1 year of study).
- Known or suspected obstruction or stricture unless patency capsule confirms patency.
- Known or suspected gastrointestinal perforation.
- Known or suspected small bowel diverticuli.
- Known swallowing disorder or the inability or unwillingness to swallow pills.
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 SB2 capsuleAlso: capsule endoscopy systemCapsule Endoscopy system | Device | CapsoCam SV-1 then PillCam SB2, PillCam SB2 then CapsoCam SV-1 |
| CapsoCam SV-1Also: Capsule endoscopyCapsule endoscopy | Device | CapsoCam SV-1 then PillCam SB2, PillCam SB2 then CapsoCam SV-1 |
Primary outcome
Normal vs Abnormal, Overall Impression
Time frame: Study Completion
The review of images of suspected diseased small bowel to determine agreement among readers between the two image capture systems: CapsoCam SV-1 and PillCam SB2. The proportion of Normal vs Abnormal, Overall Impression based upon the result of 2 out of 3 data readers in agreement.
3 secondary outcomes
Comparison of SB Transit Times With CapsoCam SV-1 and PillCam SB2
Time frame: Study Completion
Comparison of Diagnostic Yield of CapsoCam SV-1 as Compared to PillCam SB2
Time frame: Study Completion
Preference Between CapsoCam SV-1 and PillCam SB2
Time frame: Study Completion
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Shabana F Pasha, MD principal investigator
Mayo Clinic
7 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PillCam SB2 capsule and CapsoCam SV-1 in people with Intestinal Disease and Inflammatory Bowel Disease, run by Capso Vision, Inc. at 7 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 4 inclusion and 19 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 10 May 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States, Canada. 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 10 May 2017). 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?
Normal vs Abnormal, Overall Impression (time frame: Study Completion). 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 10 May 2017.