A Pilot and Feasibility Study to Evaluate Capsule Endoscopy (MA-79)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00974701
Recruitment Status : Completed
First Posted : September 10, 2009
Last Update Posted : June 10, 2011
Information provided by:
Given Imaging Ltd.

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.

Condition or disease Intervention/treatment
Upper Gastrointestinal Hemorrhage Device: PillCam ESO2

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Pilot and Feasibility Study to Evaluate Capsule Endoscopy in Subjects Presenting With Acute, Overt Upper Gastrointestinal Hemorrhage
Study Start Date : August 2009
Primary Completion Date : November 2010
Study Completion Date : November 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Patients to undergo PillCam procedure
Patients presenting to ER with acute overt upper GI bleeding
Device: 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.
Other Name: PillCam ESO 2

Primary Outcome Measures :
  1. Identification of gross blood (fresh or coffee grounds) / active bleeding in the esophagus, stomach and /or duodenum by PillCam™ ESO 2 and NG aspirate [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. Suspected anatomic location of acute overt UGI bleeding (e.g., esophageal, gastric, and/or duodenal location) by PillCam™ ESO 2 and EGD. [ Time Frame: 7 days ]
  2. Determination of suspected variceal vs. non-variceal source of acute overt UGIH by PillCam™ ESO 2 and EGD. [ Time Frame: 7 days ]
  3. Number, type and severity of adverse events and number of PillCam™ ESO 2 capsules that reached the 2nd portion of the duodenum. [ Time Frame: 7 days ]
  4. Patient subjective assessment questionnaires [ Time Frame: 7 days ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00974701

Hong Kong
Prince of Wales Hospital, Hong Kong, China
Shating, N.t., Hong Kong
Rambma Medical Center
Haifa, Israel, 31096
Sponsors and Collaborators
Given Imaging Ltd.
Principal Investigator: Josheph Sung, MD,PhD Prince of Wales Hospital, Hong Kong, China
Principal Investigator: Ian Gralnek, MD., PhD. Rambam Medical Center, Haifa, Israel

Responsible Party: Hila Debby -Director Clinical Trials, Given Imaging Ltd. Identifier: NCT00974701     History of Changes
Other Study ID Numbers: MA-79
First Posted: September 10, 2009    Key Record Dates
Last Update Posted: June 10, 2011
Last Verified: May 2010

Keywords provided by Given Imaging Ltd.:
symptoms of acute overt upper gastrointestinal hemorrhage

Additional relevant MeSH terms:
Gastrointestinal Hemorrhage
Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases