Clinical trial NCT01088646: Evaluation of PillCam® Express Capsule Endoscopy Delivery System
Official title: Evaluation of PillCam® Express Capsule Endoscopy Delivery System
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Small Bowel Disease
Inflammatory Bowel Disease
Keywords: capsule endoscopy
small bowel disease
inflammatory bowel disease
Subjects indicated for EGD endoscopy
Lead sponsor: Medtronic - MITG
Sponsor class: INDUSTRY
First posted: 2010-03-17
Enrollment: 25
Sex: ALL
Minimum age (years): 2
Maximum age (years): 85
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: To evaluate the safety and efficacy of an endoscopic capsule placement device.
Primary purpose: DEVICE_FEASIBILITY

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

Detailed description: 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

Eligibility criteria: 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

Primary outcomes:
measure: Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System
timeFrame: up to 7 days
Secondary outcomes:
measure: Physician's Subjective Assessment of the Ease of Capsule Placement
timeFrame: 7 days
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Alabama Digestive Disorders Center, P. C.
state: Alabama
city: Montgomery
country: United States
facility: Alabama Liver and Digestive Specialists
state: Alabama
city: New York
country: United States
facility: RANY -Research Associates of New York (NY Gastroenterology Associates)
state: New York
Study officials:
affiliation: Mayo Clinic
name: Jonathan Leighton, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Private Practice New York, New York
name: Peter Legnani, MD
role: PRINCIPAL_INVESTIGATOR
References: