Upper Gastrointestinal Hemorrhage Clinical Trial
— MA-79Official title:
A Pilot and Feasibility Study to Evaluate Capsule Endoscopy in Subjects Presenting With Acute, Overt Upper Gastrointestinal Hemorrhage
NCT number | NCT00974701 |
Other study ID # | MA-79 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | August 2009 |
Est. completion date | November 2010 |
Verified date | May 2010 |
Source | Medtronic - MITG |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 50 |
Est. completion date | November 2010 |
Est. primary completion date | November 2010 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Hong Kong | Prince of Wales Hospital, Hong Kong, China | Shating | N.t. |
Israel | Rambma Medical Center | Haifa |
Lead Sponsor | Collaborator |
---|---|
Medtronic - MITG |
Hong Kong, Israel,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | Suspected anatomic location of acute overt UGI bleeding (e.g., esophageal, gastric, and/or duodenal location) by PillCam™ ESO 2 and EGD. | 7 days | ||
Secondary | Determination of suspected variceal vs. non-variceal source of acute overt UGIH by PillCam™ ESO 2 and EGD. | 7 days | ||
Secondary | Number, type and severity of adverse events and number of PillCam™ ESO 2 capsules that reached the 2nd portion of the duodenum. | 7 days | ||
Secondary | Patient subjective assessment questionnaires | 7 days |
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