A Pilot and Feasibility Study to Evaluate Capsule Endoscopy

NCT ID: NCT00974701

Last Updated: 2019-07-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2010-11-30

Brief Summary

This study is aimed at assessing the capability of the PillCam Platform using the PillCam ESO 2 Capsule in:

• Determining whether there is 1) active bleeding in the Upper gastrointestinal (UGI) tract, 2) identifying the anatomic location of acute overt UGI bleeding, and 3) discriminating a variceal versus non-variceal source of UGI bleeding.

Detailed Description

Upper gastrointestinal hemorrhage (UGIH) is a prevalent, clinically significant, and expensive healthcare problem worldwide. The incidence of acute, overt UGIH has been estimated to be 50-150 cases per 100,000 adults in the United States population each year.

Clinical Significance / Rationale EGD is the currently accepted community standard for the diagnosis and management of UGIH. Diagnostic EGD in persons presenting with acute UGIH allows for (1) differentiating the source of bleeding (variceal vs. non-variceal), (2) defining the anatomic location of the bleeding site (e.g., esophagus, stomach, duodenum), (3) providing an endoscopic diagnosis, and (4) facilitating patient triage for subsequent level of care (ICU, monitored bed, non-monitored bed, early / expedited hospital discharge).

Capsule endoscopy for the small bowel was cleared by the FDA in 2001, and within a short time, has gained acceptance as providing state-of-the-art endoscopic imaging. Capsule endoscopy is now commonly used in the evaluation of patients with obscure gastrointestinal bleeding, including iron deficiency anemia, suspected and known Crohn's disease, malabsorption syndromes (e.g., Celiac disease), and chronic abdominal pain. Capsule endoscopy technology is now also being applied to evaluation of the esophagus (PillCam® ESO, Given Imaging, Ltd, Yoqneam, Israel) and the colon (PillCam® COLON). Recently, a second generation esophageal capsule endoscope (PillCam® ESO 2, Given Imaging Ltd, Yoqneam, Israel) was cleared by the United States Food and Drug Administration in June 2007. While having the same outer dimensions (length and diameter) as the original PillCam ESO capsule, several significant improvements have been made to the internal components of the PillCam ESO 2. Similar to the original PillCam ESO, the system includes a sensor array and data recording device which are connected to the patient during the procedure. The recorded data is downloaded into the Given Imaging RAPID® workstation for review of the capsule endoscopy video.

However, there are no published detailed data evaluating the feasibility of utilizing PillCam ESO 2 in individuals presenting with acute, overt UGI bleeding. Moreover, there are no data comparing PillCam ESO 2 and EGD in the evaluation of this patient population. Therefore, in this proof-of-concept pilot study, we will evaluate the feasibility and safety of using PillCam ESO 2 in individuals presenting with acute, overt UGI bleeding.

Conditions

Upper Gastrointestinal Hemorrhage

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patients to undergo PillCam procedure

Patients presenting to ER with acute overt upper GI bleeding

Group Type: EXPERIMENTAL

PillCam ESO2

Intervention Type: DEVICE

The capsule to be tested in this proposed study, PillCam ESO 2 capsule Endoscopy, is an improved version with exactly the same dimensions as the current PillCam ESO capsule, both in length and diameter.

Interventions

PillCam ESO2

The capsule to be tested in this proposed study, PillCam ESO 2 capsule Endoscopy, is an improved version with exactly the same dimensions as the current PillCam ESO capsule, both in length and diameter.

Intervention Type: DEVICE

Other Intervention Names

PillCam ESO 2

Eligibility Criteria

Inclusion Criteria

• age ≥ 18 years
• history of acute, overt UGI hemorrhage, defined as hematemesis (fresh blood or coffee grounds) and/or melena within the 48 hours prior to patient presentation

Exclusion Criteria

• dysphagia
• odynophagia
• known swallowing disorder
• history of Zencker's diverticulum
• suspected bowel obstruction or bowel perforation at the time of presentation
• UGI hemorrhage with hemodynamic shock requiring urgent endoscopy
• history of prior bowel obstruction
• history of Crohn's disease
• history of UGI tract surgery (e.g., Billroth I, Billroth II, esophagectomy, gastrectomy, bariatric procedure)
• presence of an electromedical device (pacemaker or internal cardiac defibrillator)
• altered mental status (e.g., hepatic encephalopathy) at the time of presentation that would limit patient ability in swallowing the capsule
• pregnancy
• known allergy to conscious sedation medications
• known allergy to erythromycin
• inability to provide written informed consent

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medtronic - MITG

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Josheph Sung, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

Prince of Wales Hospital, Hong Kong, China

Ian Gralnek, MD., PhD.

Role: PRINCIPAL_INVESTIGATOR

Rambam Medical Center, Haifa, Israel

Locations

Prince of Wales Hospital, Hong Kong, China

Shating, N.T., Hong Kong

Rambma Medical Center

Haifa, , Israel

Countries

Hong Kong; Israel

Other Identifiers

MA-79

Identifier Type: -

Identifier Source: org_study_id