Clinical trial · Interventional
Project PREVAM : Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy
Prospective Comparison of Capsule Endoscopy Pillcam II™ Versus Colonoscopy for the Detection of Adenomatous Polyps and Cancer in a High Risk Population
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Adenomatous Polyps | Adenomatous Polyp | ALIAS | 0.90 |
| Cancer | Malignant Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Comparison of capsule endoscopy Pillcam II™ versus colonoscopy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- A
- description
- On the same patient, we compare both methods (video-colonoscopy vs capsule endoscopy)
- interventionNames
- Device: Comparison of capsule endoscopy Pillcam II™ versus colonoscopy
Primary outcomes (1)
- measure
- Number of Participants with Adverse Events as a Measure of Safety and Tolerability
- timeFrame
- 7 days
- description
- The investigators want to know if the capsule endoscopie is more or less effective than colonoscopy to detect lesion or abdominal cancer.
Secondary outcomes (1)
- measure
- Pain Scores on the Visual Analog Scale
- timeFrame
- 7 days
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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 * Patient with social insurance * Persons already participating in another clinical trial.. * Signature of informed consent Exclusion Criteria: * 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 * Intolerance with dompéridon and/or bisacodyl * Intolerance with oral intake of NaP, polyethylen glycol (PEG) or macrogol * Colonoscopy contre indication for anesthesiologic reasons
References
Publications (1)
- DERIVEDParodi 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. PMID 28554656