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

February 24, 2014 updated by: Dr. Dan Carter, Gastroenterologist, Sheba Medical Center

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

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

Study Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Ramat Gan, Israel, 52621
        • Recruiting
        • Sheba Medical Center
        • Contact:
        • Principal Investigator:
          • Dan Carter, MD
        • Sub-Investigator:
          • Eytan Bardan, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any patient undergoing small bowel video capsule examination for any indication

Description

Inclusion Criteria:

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

Exclusion Criteria:

-Endoscopic intraduodenal insertion of the capsule -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Duration of capsule retention in the stomach
Time Frame: End of capsule examination
End of capsule examination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sheba Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2013

Primary Completion (Anticipated)

June 1, 2014

Study Completion (Anticipated)

January 1, 2015

Study Registration Dates

First Submitted

May 12, 2013

First Submitted That Met QC Criteria

May 14, 2013

First Posted (Estimate)

May 21, 2013

Study Record Updates

Last Update Posted (Estimate)

February 25, 2014

Last Update Submitted That Met QC Criteria

February 24, 2014

Last Verified

February 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Sheba-9180-2011

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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