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NCT01858220 Clinical Trial

IS There a Correlation Between Sypmtoms of Gastroparesis and the Duration of Video Caspule Retention in the Stomach

Gastroparesis Clinical Trial

Official title:
Open Prospective Single Center Study for the Determination of Correlation Between Video Capsule Period of Retention in the Stomach and Symptoms of Gastroparesis

Clinical Trial Details — Status: Unknown status

Administrative data
NCT number NCT01858220
Other study ID # Sheba-9180-2011
Secondary ID
Status Unknown status
Phase N/A
First received May 12, 2013
Last updated February 24, 2014
Start date January 2013
Est. completion date January 2015

Study information
Verified date February 2014
Source Sheba Medical Center
Contact Dan Carter, MD
Phone 972-3-5302197
Email carterd@zahav.net.il
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Gastroparesis is a syndrome characterized by delayed gastric emptying in absence of mechanical obstruction of the stomach. The cardinal symptoms include postprandial fullness (early satiety), nausea, vomiting, and bloating.Capsule endoscopy (CE) has evolved to become a first-line, noninvasive diagnostic technique for the small bowel. CE is now being utilized to assess patients for obscure gastrointestinal bleeding, possible Crohn's disease, celiac disease and small bowel tumors. Capsule endoscopy is preformed in a fasting state, and usually past the pylorus of the stomach into the duodenum after up to 30-40 minutes. The aim of the study is to determine the correlation between gasytoparesis symptoms to duration of capsule retention in the stomach

Recruitment information / eligibility
Status Unknown status
Enrollment 100
Est. completion date January 2015
Est. primary completion date June 2014
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Age > 18 years

- Undergoing video capsule endoscopy for any indication

Exclusion Criteria:

-Endoscopic intraduodenal insertion of the capsule -

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Israel Sheba Medical Center Ramat Gan

Sponsors (1)
Lead Sponsor Collaborator
Sheba Medical Center

Country where clinical trial is conducted

Israel, 

Outcome
Type Measure Description Time frame Safety issue
Primary Duration of capsule retention in the stomach End of capsule examination
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