N/A N=25 Single-blind Device Feasibility

Evaluation of PillCam® Express Capsule Endoscopy Delivery System

Small Bowel Disease · Inflammatory Bowel Disease

Bottom Line

View on ClinicalTrials.gov: NCT01088646 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System — 25 participants

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: PillCam® Express Capsule Endoscopy Delivery System (Device)
Age: Pediatric, Adult, Older Adult · 2+ yrs
Sex: All
Sponsor: Medtronic - MITG
Primary completion: May 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Number of Participants With Successful Capsule Placement Into the Duodenum Using Capsule Delivery System	25	—
SECONDARY Physician's Subjective Assessment of the Ease of Capsule Placement	94; 126	—

Summary

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

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01088646). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.