Adenomatous PolypsNCT01184781
Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy
A study testing Comparison of capsule endoscopy Pillcam II™ versus colonoscopy in people with Adenomatous Polyps and Cancer, run by Centre Hospitalier Universitaire de Nice at 2 sites in 2 countries.
Trial summary
The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adenomatous Polyps, Cancer
- What is being tested?
- Comparison of capsule endoscopy Pillcam II™ versus colonoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Aug 2010to Nov 2013
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age > 18 years old
- Patient with 40 years old and first degree relative affected by colo rectal cancer at age ≥ 60 ans
- Patient with 40 years old or ten years before the age at affected disease in case or first deree relative colo rectal cancer before 60 years old.
- Fecal occult blood test positive
- Personal history of adenomatous polyps
- Personnal history of acromegaly
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- Patient with social insurance
- Persons already participating in another clinical trial..
- Signature of informed consent
Who cannot join
- Pregnancy or breast feeding woman
- Déficience mentale du sujet rendant sa participation à l'essai impossible
- Pacemaker or all electronic devices implanted
- Patient with swallowing disorder, or digestive stricture know or suspected by the investigator
- Previous history of intestinal surgery, radiotherapy or inflammatory bowel disease
- Previous history of polyadenomatous congenital disease, Lynch syndrome
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- Intolerance with dompéridon and/or bisacodyl
- Intolerance with oral intake of NaP, polyethylen glycol (PEG) or macrogol
- Colonoscopy contre indication for anesthesiologic reasons
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population
The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.
- Conditions
- Adenomatous Polyps, Cancer
- Being tested
- Comparison of capsule endoscopy Pillcam II™ versus colonoscopy
- Medical subject headings
- Adenomatous Polyps, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comparison of capsule endoscopy Pillcam II™ versus colonoscopyDevice
On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)
| Study group | Role | What they receive |
|---|---|---|
| A | Other | On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy) Receives: Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.
Measured: 7 days
Secondary outcomes (1)
Pain Scores on the Visual Analog Scale
Presence of at least one polyp at capsule endoscopy and colonoscopy with both operators unaware of each other's findings until completion of the procedures.
Comparison of the different class of size for all polyps Comparison of Kudo and Paris classification of the polyps at endoscopy capsule and colonoscopy Tolerance, pain and discomfort between the both procedure Acceptability of both procedure at day 1 and day 7 Accuracy of the localization of the polyp or the lesion at the capsule endosocpy comparated with the colonoscopy topography (Gold standard).
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2010 (estimated)
- Study startAug 2010
- Primary completionSep 2010
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adenomatous PolypsStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de NiceThe 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HEBUTERNE Xavier, PU-PH, Study director, Digestive department
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01184781
- Sponsor's protocol ID
- 10-PP-02
- Status last verified
- Sep 2023
- First submitted
- 26 Jul 2010
- Last updated
- 8 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Parodi A, Vanbiervliet G, Hassan C, Hebuterne X, De Ceglie A, Filiberti RA, Spada C, Conio M. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer. Gastrointest Endosc. 2018 Mar;87(3):695-704. doi: 10.1016/j.gie.2017.05.023. Epub 2017 May 26.
PubMed 28554656
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population
- ClinicalTrials.gov ID
- NCT01184781
- Acronym / sponsor ID
- 10-PP-02
- Conditions
- Adenomatous Polyps, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NiceUniversity, hospital or other
- Study start
- Aug 2010 (actual)
- Primary completion
- Sep 2010 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 19 Aug 2010 (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.
The aim of the study is to perform a prospective, multicenter research comparing capsule endoscopy with the video colonoscopy in the detection of the adenomatous polyps and cancer specifically in a high risk population (sensibility, specificity, NPV, PPV and diagnostic accuracy). The investigators will used the Pillcam II™ colon capsule (second generation) and a high resolution colonoscope (with high definition). Both procedures will be perform in the same day with an adapted bowel preparation.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | Other | Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopyOn the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age > 18 years old
- Patient with 40 years old and first degree relative affected by colo rectal cancer at age ≥ 60 ans
- Patient with 40 years old or ten years before the age at affected disease in case or first deree relative colo rectal cancer before 60 years old.
- Fecal occult blood test positive
- Personal history of adenomatous polyps
Key exclusion criteria (9 listed)
- Pregnancy or breast feeding woman
- Déficience mentale du sujet rendant sa participation à l'essai impossible
- Pacemaker or all electronic devices implanted
- Patient with swallowing disorder, or digestive stricture know or suspected by the investigator
- Previous history of intestinal surgery, radiotherapy or inflammatory bowel disease
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 |
|---|---|---|
| Comparison of capsule endoscopy Pillcam II™ versus colonoscopyOn the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy) | Device | A |
Primary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Time frame: 7 days
The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.
1 secondary outcome
Pain Scores on the Visual Analog Scale
Time frame: 7 days
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 8 Sep 2023.
- Derived from this study: PubMed 28554656Parodi A, Vanbiervliet G, Hassan C, Hebuterne X, De Ceglie A, Filiberti RA, Spada C, Conio M. Colon capsule endoscopy to screen for colorectal neoplasia in those with family histories of colorectal cancer. Gastrointest Endosc. 2018 Mar;87(3):695-704. doi: 10.1016/j.gie.2017.05.023. Epub 2017 May 26.
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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.
HEBUTERNE Xavier, PU-PH study director
Digestive department
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Comparison of capsule endoscopy Pillcam II™ versus colonoscopy in people with Adenomatous Polyps and Cancer, run by Centre Hospitalier Universitaire de Nice at 2 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 9 inclusion and 9 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 8 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France, Italy. 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?
Number of Participants with Adverse Events as a Measure of Safety and Tolerability (time frame: 7 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01184781, which also lists 1 linked publication.
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 8 Sep 2023.