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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified February 2014 by Dr. Dan Carter, Gastroenterologist, Sheba Medical Center.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01858220
First Posted: May 21, 2013
Last Update Posted: October 12, 2017
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.
Information provided by (Responsible Party):
Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
  Purpose
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
Gastroparesis

Study Type: Observational
Study Design: 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

Further study details as provided by Dr. Dan Carter, Gastroenterologist, Sheba Medical Center:

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

Estimated Enrollment: 100
Study Start Date: January 2013
Estimated Study Completion Date: January 2015
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Video capsule examinee
Every subject having capsule endoscopy for any indication

  Eligibility

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 Submitted: May 12, 2013
First Posted: May 21, 2013
Last Update Posted: October 12, 2017
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