Clinical trial · Observational
PillCam® ESO 2 in Esophageal Pathologies
Evaluation of PillCam® ESO 2 in Patients With Suspected Esophageal Pathologies
NCT00885469CI-TRIAL-00039822MA-76completedClinicalTrials.gov clinicaltrialsProvenance
- 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)
Study Hypothesis: * PillCam™ ESO-2 will demonstrate equivalent accuracy parameters as compared to blinded esophagogastroduodenoscopy (EGD) in detecting suspected Barrett's esophagus, detecting and grading esophagitis. * PillCam™ ESO will demonstrate all safety parameters as compared to EGD * PillCam™ ESO-2 will demonstrate better patient's satisfaction as compared to EGD
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 |
|---|---|---|---|
| Barrett's Esophagus | — | UNRESOLVED | — |
| Gastroesophageal Reflux Disease | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- 1
- description
- Patients with known Barrett's Esophagus or chronic GERD
Primary outcomes (1)
- measure
- Accuracy parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting suspected Barrett's Esophagus (BE) as compared to standard EGD, using unblinded EGD as the reference standard.
- timeFrame
- 7 days
Secondary outcomes (3)
- measure
- Level of agreement (i.e. positive, negative and overall agreement parameters) between PillCam ESO 2 and standard EGD in classifying the Z-line following the ZAP score (Wallner et. al 2002), where Grades 0&I and grades II&III will be consolidated.
- timeFrame
- 7 days
- measure
- Accuracy Parameters (sensitivity, specificity, NPV, PPV) of PillCam ESO 2 in detecting Esophagitis as compared to standard EGD, using unblinded EGD as the reference standard.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patient age is 18 years or older * Patient is known or suspected to suffer from an esophageal disease based on his/her medical history and recent symptoms suggestive of GERD or BE * Patient agrees and signs the Informed Consent Form * Currently taking PPI for at least 28 days. Exclusion Criteria: * Patient has dysphagia * Patient has known Zenker's Diverticulum * Patient is known or is suspected to suffer from esophageal and/or intestinal obstruction * Patient has a cardiac pacemakers or other implanted electro medical devices * Patient who has undergone an EGD within past seven days * Female patient is pregnant and/or lactating * Patient is expected to undergo Magnetic Resonance Imaging (MRI) examination within 7 days after ingestion of the capsule * Patient has had a prior pelvic or 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 such as appendectomy or uncomplicated cholecystectomy) * Patient has any condition which precludes compliance with the study and/or device instructions * Patient suffers from life threatening conditions * Patient is currently participating in another clinical study * Patient is on medications that may coat the esophagus such as iron or sulcrafate. * Contraindication for any radiation or barium (e.g., sensitivity or allergy) required to confirm excretion of the capsule if necessary. * Patient is currently suffering from conditions like allergy, illness (flu) or anything else that causes congestion, excessive salivation, etc. that could foster difficulty in swallowing the capsule or affect the clarity of the CE images. * Contraindicated for use of laxatives, or surgery required to remove a capsule e.g., colonoscopy.
References
Publications (0)
Data not yet available
No reference posted for this study.