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

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Sheba Medical Center
Sponsor:
Information provided by (Responsible Party):
Dr. Dan Carter, Gastroenterologist, Sheba Medical Center
ClinicalTrials.gov Identifier:
NCT01858220
First received: May 12, 2013
Last updated: February 24, 2014
Last verified: February 2014
  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 Sheba Medical Center:

Primary Outcome Measures:
  • Duration of capsule retention in the stomach [ Time Frame: End of capsule examination ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 12, 2013
Last Updated: February 24, 2014
Health Authority: Israel: Ethics Commission

Keywords provided by Sheba Medical Center:
Gastroparesis
Small bowel video capsule
gastric retention

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

ClinicalTrials.gov processed this record on November 20, 2014