NCT00974701

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2009

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2009

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

September 9, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 10, 2009

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2010

Completed
Last Updated

July 31, 2019

Status Verified

May 1, 2010

Enrollment Period

1.3 years

First QC Date

September 9, 2009

Last Update Submit

July 29, 2019

Conditions

Upper Gastrointestinal Hemorrhage

Keywords

symptoms of acute overt upper gastrointestinal hemorrhage

Outcome Measures

Primary Outcomes (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

    7 days

Secondary Outcomes (4)

  • Suspected anatomic location of acute overt UGI bleeding (e.g., esophageal, gastric, and/or duodenal location) by PillCam™ ESO 2 and EGD.

    7 days

  • Determination of suspected variceal vs. non-variceal source of acute overt UGIH by PillCam™ ESO 2 and EGD.

    7 days

  • Number, type and severity of adverse events and number of PillCam™ ESO 2 capsules that reached the 2nd portion of the duodenum.

    7 days

  • Patient subjective assessment questionnaires

    7 days

Study Arms (1)

Patients to undergo PillCam procedure

EXPERIMENTAL

Patients presenting to ER with acute overt upper GI bleeding

Device: PillCam ESO2

Interventions

PillCam ESO2DEVICE

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.

Also known as: PillCam ESO 2
Patients to undergo PillCam procedure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Prince of Wales Hospital, Hong Kong, China

Shating, N.T., Hong Kong

Location

Rambma Medical Center

Haifa, 31096, Israel

Location

MeSH Terms

Conditions

Gastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Gastrointestinal DiseasesDigestive System DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Josheph Sung, MD,PhD

    Prince of Wales Hospital, Hong Kong, China

    PRINCIPAL INVESTIGATOR

  • Ian Gralnek, MD., PhD.

    Rambam Medical Center, Haifa, Israel

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 9, 2009

First Posted

September 10, 2009

Study Start

August 1, 2009

Primary Completion

November 1, 2010

Study Completion

November 1, 2010

Last Updated

July 31, 2019

Record last verified: 2010-05

Locations

IL(1)HK(1)