Evaluation of the PillCam™ Colon Capsule Endoscopy (PCCE) in the Visualization of the Colon
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
The Given® Diagnostic System offers an alternative approach for endoscopic visualization of the colon using capsule endoscopy, a swallowable device which contains imagers, light sources, a power source and a RF transmitter. Advantages of the Given® Diagnostic System include the elimination of the need for conscious sedation, the minimally invasive, painless nature of the exam, and the ability to pursue normal daily activities immediately following the procedure . This multi-center prospective, cohort study will evaluate the performance of PCCE in visualizing the colon. Up to 394 subjects will participate in this study. All subjects to be enrolled will be appropriate candidates for standard colonoscopy based on their clinical indication.
Each subject will undergo PCCE. All generated PCCE RAPID videos will be reviewed by blinded PCCE reading physicians. All readers, experienced in PillCam SB, will have undergone standardized training and passed a qualification test specific to reading and interpreting PCCE videos. Training will be done by reading at least 5 cases to demonstrate proficiency in interpretation of PCCE. PCCE results will be compared with that of a colonoscopy procedure.
Following PCCE procedure, standard colonoscopy will be performed by a colonoscopist blinded to the results of the PCCE. The colonoscopist will be "unblinded" during the standard colonoscopy procedure at three locations on withdrawal of the colonoscope.
Primary Endpoint - Accuracy parameters (sensitivity, specificity, NPV, PPV) of PCCE compared to standard colonoscopy.
• Number, type and severity of adverse events with both PCCE and standard colonoscopy
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
-
Haifa, Israël
- Rambam Medical Center
-
-
-
-
Arizona
-
Scottsdale, Arizona, États-Unis, 85259
- Mayo Clinic Arizona
-
-
Indiana
-
Indianapolis, Indiana, États-Unis, 46202
- Indiana University Hospital
-
-
Minnesota
-
Minneapolis, Minnesota, États-Unis, 55446
- Minnesota Gastroenterology
-
Rochester, Minnesota, États-Unis, 55905
- Mayo Clinic Rochester
-
-
New York
-
New York, New York, États-Unis, 10128
- Private Medical Facility
-
-
Oregon
-
Portland, Oregon, États-Unis, 97239-3098
- Oregon Health Sciences University
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
Inclusion criteria:
Subjects must meet one the following inclusion criteria to be eligible for enrollment into this proposed study:
Subject was referred for standard colonoscopy for one of the following reasons:
Subjects over 50 years of age with one or more of the following clinical symptoms:
rectal bleeding, hematochezia, melena, positive FOBT, recent change of bowel habits
• Any subject over 18 years of age with:
- Positive findings in the colon on a GI radiographic study (e.g., CT colonography, air-contrast barium enema, abdominal/pelvic CT scan)
- Personal history of colorectal cancer (CRC) or adenomatous colonic polyps and at least 5 years since last colonoscopy or no sooner than 3 years prior to enrollment date as long as their prior colonoscopy revealed at least one of the following high risk conditions: multiple (greater than 3)adenomas, large adenoma (greater than 1 cm) , adenomas with a villous component, adenoma with high grade dysplasia.
- Suspected or known ulcerative colitis
Exclusion criteria
The presence of any of the following will exclude a subject from study enrollment:
- Subject has dysphagia
- Subject has congestive heart failure
- Subject has renal insufficiency
- Subject is known or is suspected to suffer from intestinal obstruction.
- Subject has a cardiac pacemaker or other implanted electro medical devices.
- Subject is pregnant
- Subject is expected to undergo MRI examination within 7 days after ingestion of the capsule.
- Subject 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.
- Subject has any condition, which precludes compliance with study and/or device instructions.
- Age less than 18
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Perspectives temporelles: Éventuel
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Douglas Rex, M.D., Indiana University Hospital
- Chercheur principal: Glenn Eisen, M.D., Oregon Health and Science University
- Chercheur principal: Chris Gostout, MD, Mayo Clinic
- Chercheur principal: Blair Lewis, MD, Private Medical Facility
- Chercheur principal: S Ketover, MD, Minnesota Gastroenterology
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- MA-54
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
produit fabriqué et exporté des États-Unis.
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .