Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.

Detailed Description
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Natural ingestion of a wireless capsule endoscope (e.g. PillCam™ SB) is contraindicated in subjects with oropharyngeal or mechanical dysphagia, gastroparesis and known or suspected anatomical abnormalities. In addition, ingestion of a wireless capsule endoscope may be challenging in the pediatric population. The PillCam® Express Capsule Endoscopy Delivery System is intended to provide physicians with the capability to place capsules in the proximal duodenum using the accessory channel of a standard endoscope. The PillCam™ SB capsule to be used in this study was cleared by the FDA in August 2001 for small bowel evaluation. It has been ingested to date by more than 1,000,000 people worldwide and is well accepted by subjects and physicians as well as the professional societies. Further details of the PillCam®Express Capsule Endoscopy Delivery System can be found in the device description section. This study is designed to evaluate the performance and safety of the Capsule Endoscopy Delivery System in subjects indicated to undergo a standard Esophagogastroduodenoscopy (EGD) endoscopy

Official Title
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Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Conditions
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Small Bowel Disease, Inflammatory Bowel Disease

Intervention / Treatment
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* Device: PillCam® Express Capsule Endoscopy Delivery System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 2 years Subject scheduled for EGD endoscopy with a 2.8 mm (or greater) working channel Exclusion criteria: Subject is known or is suspected to suffer from bowel obstruction or bowel perforation at the time of presentation Subject has history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure) Presence of an electro-medical device (pacemaker or internal cardiac defibrillator) Subject is pregnant Subject is expected to undergo a MRI examination within 7 days after ingestion of the capsule Subject has known allergy to conscious sedation medications Subject or legal guardian is not able to provide written informed consent

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Interventional Model Description: To evaluate the safety and efficacy of an endoscopic capsule placement device.
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: PillCam® Express Capsule Endoscopy Delivery System|The PillCam® Express Capsule Endoscopy Delivery System is comprised of three parts: a catheter, a syringe and the capsule holder. The catheter is passed through the accessory channel of a standard endoscope and the capsule holder is snapped on to the distal end of the device. The endoscope is used to guide the Capsule Endoscopy Delivery System to the proximal duodenum. The capsule is then released pneumatically, using an air-filled syringe attached to the proximal end of the catheter. Once the capsule is deployed, the endoscope is withdrawn and the capsule holder is cut off at the distal part of the device with scissors. The catheter is then retracted and discarded. The PillCam® Express Capsule Endoscopy Delivery System is single-use, disposable and latex-free.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System | The number of capsules that successfully were in the duodenum as indicated by video images | up to 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physician's Subjective Assessment of the Ease of Capsule Placement | The physician was required to assess the ease of use while answering a designated questionnaire. In addition, qualitative analysis was reformed with regard to all the open questions. | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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capsule endoscopy, small bowel disease, inflammatory bowel disease, Subjects indicated for EGD endoscopy