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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00588224 |
The goal is to study the accuracy of 3-dimensional ultrasound (which does not involve radiation) to measure the size of the stomach, comparing it with a previously validated method that involves radiation. This will make it possible to check the stomach function of children without exposing them to radiation. A second goal is to measure the size of the stomach and the effect of a standard meal on stomach volume in adolescent boys and girls.
Condition | Intervention |
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Healthy |
Other: 3D ultrasound |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Validation and Application of 3-Dimensional Ultrasound for Measurement of Gastric Volumes in Healthy Subjects |
Estimated Enrollment: | 36 |
Study Start Date: | October 2007 |
Estimated Study Completion Date: | June 2008 |
Estimated Primary Completion Date: | June 2008 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
adults
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Other: 3D ultrasound
measurement of stomach volume by 3D ultrasound
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2
adolescents
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Other: 3D ultrasound
measurement of stomach volume by 3D ultrasound
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Specific Aims
Study Design
The study will be conducted in 2 parts: first, 12 healthy adults will undergo SPECT and 3-D ultrasound in random order (aim 1); one week after the first ultrasound examination, a second Ultrasound examination will be conducted in all participants (aim 2) In the second part, 24 adolescents (12 in each gender, 12 aged 13-15, 12 aged 16-18)) will undergo a single determination of fasting and postprandial gastric volumes during fasting and post-prandially. The methods and validation of the SPECT study have been previously published (2). Three D ultrasonography will be conducted using state of the art equipment following methods published in the literature. (3)
The study will screen 80 healthy adults or adolescents in order to enroll 12 healthy adulkts for the first two aims, and 24 adolescent healthy subjects for the third aim.
For subjects in group 1, the order of SPECT and 3D- ultrasound tests will be randomized.
The randomization assignments will be made according to a pre-study schedule prepared by the Section of Biostatistics. Medical investigators will be blinded to assignment, allocation will be concealed
Ages Eligible for Study: | 13 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Probability Sample |
ealthy adolescents and adults: The study will screen up to 80 healthy adults or adolescents in order to enroll 12 healthy adults for the first two aims, and 24 adolescent healthy subjects for the third aim
Inclusion Criteria:
Exclusion Criteria:
Use of drugs or agents within the past 2 weeks that alter GI transit including laxatives, magnesium or aluminum-containing antacids, prokinetics, erythromycin, narcotics, anticholinergics, tricyclic antidepressants, SSRI and newer antidepressants.
NOTE: Low stable doses of thyroid replacement, estrogen replacement, low dose aspirin for cardioprotection, and birth control pills or depot injections are permissible.
Contact: Deborah Eckert, RN | 507-266-8020 | eckert.deborah@mayo.edu |
United States, Minnesota | |
Mayo Clinic | Recruiting |
Rochester, Minnesota, United States, 55905 | |
Principal Investigator: Michael L Camilleri, MD |
Principal Investigator: | Michael L Camilleri, MD | Mayo Clinic |
Responsible Party: | Mayo Clinic ( Michael Camilleri MD ) |
Study ID Numbers: | 07-005231 |
Study First Received: | December 22, 2007 |
Last Updated: | January 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00588224 History of Changes |
Health Authority: | United States: Institutional Review Board |
stomach accommodation volume |
SPECT 3 dimensional ultrasonography healthy volunteers |
Healthy |