Inflammatory Bowel Disease Clinical Trial
— RD-300Official title:
Evaluation of PillCam® Express Capsule Endoscopy Delivery System
NCT number | NCT01088646 |
Other study ID # | RD-300 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | October 2009 |
Est. completion date | May 2010 |
Verified date | September 2020 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The purpose of this study is to evaluate the safety and efficacy of a trans-endoscopic capsule placement Capsule Endoscopy Delivery System.
Status | Completed |
Enrollment | 25 |
Est. completion date | May 2010 |
Est. primary completion date | May 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years to 85 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Alabama Digestive Disorders Center, P. C. | Huntsville | Alabama |
United States | Alabama Liver and Digestive Specialists | Montgomery | Alabama |
United States | RANY -Research Associates of New York (NY Gastroenterology Associates) | New York | New York |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 |
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