AnemiaNCT01820182
Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule
A study testing capsule endoscopies in people with Anemia and Gastrointestinal Bleedings, run by Hôpital Edouard Herriot.
Trial summary
Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Anemia, Gastrointestinal Bleedings, Méléna
- What is being tested?
- capsule endoscopies
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 73 participants
- Where
- No sites listed yet
- Study dates
- Jan 2011to Jun 2012
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- over 18 years old
- obscure digestive bleeding justifying capsule endoscopy
- complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation
- absence of concomittent ongoing study
- absence of occlusive symptoms of suspected Crohn's disease nor of previous small bowel radiotherapy
- filled inform consent
- no implanted pace maker
- patient being affiliated to the CPAM
Who cannot join
- under 18 years old
- oral iron within 8 days before capsule endoscopy
- gastroparesis
- pacemaker
- swallowing troubles
- presence of oclusive symptoms suspected Crohn's disease nor of previous small bowel radiotherapy
- pregnancy or risk of pregnancy without efficient oral contraception
- absence of written informed consent
About this study
Official title: Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings
Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.
Read the detailed description
Objectives
Main objective
To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k>0,6
Secondary objectives
To compare the sensitivity and specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time
- Conditions
- Anemia, Gastrointestinal Bleedings, Méléna, Angiodysplasia, Polyps
- Being tested
- capsule endoscopies
- Medical subject headings
- Anemia, Angiodysplasia, Polyps
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
capsule endoscopiesDevice
Also called Pillcam SB2, Capsocam
Patients inclusion following inclusion criterias Randomization of capsule ingestion order Videocapsule recording by the two capsules Reading of the two capsules films in randomized order by two different readers in each center Reviewing of discordant capsule films by an expert panel
| Study group | Role | What they receive |
|---|---|---|
| capsocam capsula | Experimental | capsocam capsula readings Receives: Device: capsule endoscopies |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of discordant films between the two capsules with two different readers
Reading of the two capsules film is randomized order by two different readers in each center
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2013 (estimated)
- Study startJan 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnemiaStudies 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
- 73 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hôpital Edouard Herriot
- Sponsor type
- University, hospital or other
- Collaborators
- Capso Vision, Inc.
- Responsible party
- Principal investigator, Jean Christophe Saurin, Hôpital Edouard Herriot
- Investigators
- Saurin JS Jean Christophe, Msd, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01820182
- Sponsor's protocol ID
- 2010-023341-29
- Status last verified
- Sep 2023
- First submitted
- 21 Mar 2013
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of the Diagnostic Yield of Small Bowel Pillcam SB2 and Capsocam Capsule in Patients With Obscure Digestive Bleedings
- ClinicalTrials.gov ID
- NCT01820182
- Acronym / sponsor ID
- 2010-023341-29
- Conditions
- Anemia, Gastrointestinal Bleedings, Méléna, Angiodysplasia, Polyps
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 73 participants (actual)
- Lead sponsor
- Hôpital Edouard HerriotUniversity, hospital or other
- Collaborators
- Capso Vision, Inc.
- Study start
- Jan 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 28 Mar 2013 (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.
Comparative, randomized study patients are scheduled to have two capsule endoscopies within 2 to 14 days from each other using two different endoscopies the Pillcam SB2 (Given Imaging, Israel) and the Capsocam (Capso Vision Saratoga United States) The order in which the devices are administered is randomly allocated.
Detailed description
Objectives
Main objective
To compare the diagnostic yield of both capsules in the same patients with a satisfying concordance coefficient k>0,6
Secondary objectives
To compare the sensitivity and specificity of both capsule readings To copmpare the sensitivity and specificity for specific lesions classified in terms of relevance P0 P1 P2 To check the tecnical fiability (incidence of technical issues To check the feasibility To evaluate the rate of complete small bowel examination, the small bowel transit time the capsule reading time
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| capsocam capsula | Experimental | Device: capsule endoscopiescapsocam capsula readings |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- over 18 years old
- obscure digestive bleeding justifying capsule endoscopy
- complete endoscopic work up including colonoscopy with ileoscopy and gastroscopy with aneathesia or sedation
- absence of concomittent ongoing study
- absence of occlusive symptoms of suspected Crohn's disease nor of previous small bowel radiotherapy
Key exclusion criteria (8 listed)
- under 18 years old
- oral iron within 8 days before capsule endoscopy
- gastroparesis
- pacemaker
- swallowing troubles
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 endoscopiesAlso: Pillcam SB2, CapsocamPatients inclusion following inclusion criterias Randomization of capsule ingestion order Videocapsule recording by the two capsules Reading of the two capsules films in randomized order by two different readers in each center Reviewing of discordant capsule films by an expert panel | Device | capsocam capsula |
Primary outcome
number of discordant films between the two capsules with two different readers
Time frame: 14 days
Reading of the two capsules film is randomized order by two different readers in each center
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 21 Sep 2023.
- 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.
Saurin JS Jean Christophe, Msd principal investigator
Questions about this trial
What is this clinical trial studying?
A study testing capsule endoscopies in people with Anemia and Gastrointestinal Bleedings, run by Hôpital Edouard Herriot.
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 8 inclusion and 8 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 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
number of discordant films between the two capsules with two different readers (time frame: 14 days). 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 21 Sep 2023.