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

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ClinicalTrials.gov Identifier: NCT01858220
Recruitment Status : Unknown
Verified February 2014 by Dr. Dan Carter, Gastroenterologist, Sheba Medical Center.
Recruitment status was:  Recruiting
First Posted : May 21, 2013
Last Update Posted : February 25, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief 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

Condition or disease
Gastroparesis

Study Design

Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Case-Only
Time Perspective: Prospective
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
Study Start Date : January 2013
Estimated Primary Completion Date : June 2014
Estimated Study Completion Date : January 2015
Groups and Cohorts

Group/Cohort
Video capsule examinee
Every subject having capsule endoscopy for any indication


Outcome Measures

Primary Outcome Measures :
  1. Duration of capsule retention in the stomach [ Time Frame: End of capsule examination ]

Eligibility Criteria

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
Sampling Method:   Non-Probability Sample
Study Population
Any patient undergoing small bowel video capsule examination for any indication
Criteria

Inclusion Criteria:

  • Age > 18 years
  • Undergoing video capsule endoscopy for any indication

Exclusion Criteria:

-Endoscopic intraduodenal insertion of the capsule -

Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT01858220


Contacts
Contact: Dan Carter, MD 972-3-5302197 carterd@zahav.net.il

Locations
Israel
Sheba Medical Center Recruiting
Ramat Gan, Israel, 52621
Contact: Dan Carter, MD    972-3-5302197    carterd@zahav.net.il   
Principal Investigator: Dan Carter, MD         
Sub-Investigator: Eytan Bardan, MD         
Sponsors and Collaborators
Sheba Medical Center
More Information

Responsible Party: Dr. Dan Carter, Gastroenterologist, Senior GI Consult, Sheba Medical Center
ClinicalTrials.gov Identifier: NCT01858220     History of Changes
Other Study ID Numbers: Sheba-9180-2011
First Posted: May 21, 2013    Key Record Dates
Last Update Posted: February 25, 2014
Last Verified: February 2014

Keywords provided by Dr. Dan Carter, Gastroenterologist, Sheba Medical Center:
Gastroparesis
Small bowel video capsule
gastric retention

Additional relevant MeSH terms:
Gastroparesis
Stomach Diseases
Gastrointestinal Diseases
Digestive System Diseases
Paralysis
Neurologic Manifestations
Signs and Symptoms