3D Ultrasound Validation for Measuring Stomach Volume

NCT00588224 | Completed

• 1 other identifier: 07-005231
• Study Type: observational
• Target: 36
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Healthy

Keywords

stomach; accommodation; volume; SPECT; 3 dimensional ultrasonography; healthy volunteers

Outcome Measures

Primary Outcomes (1)

• Fasting and Postprandial gastric volumes measured by 3D ultrasonography in adults and adolescents

  one month

Secondary Outcomes (2)

• Intra and inter-individual COV in adults for fasting and postprandial volumes

  one month

• Accuracy of 3D-ultrasonography in measurement of fasting and posprandial volume using Bland-Altman plot

  one month

Study Arms (2)

1

adults

Other: 3D ultrasound

2

adolescents

Other: 3D ultrasound

Interventions

3D ultrasound OTHER

measurement of stomach volume by 3D ultrasound

1; 2

Eligibility Criteria

• Age: 13 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• Age: 13-65 years
• Body mass index (BMI): 18 to 32 (exept in adolescents)
• Negative urine pregnancy test for women of childbearing potential
• Absence of gastrointestinal symptoms (abridged Bowel Disease Questionnaire)
• Signed informed consent

You may not qualify if:

• Subjects with body mass index (BMI) of less than 18 or more than 32.
• Structural or metabolic diseases/conditions that affect the gastrointestinal system, or functional gastrointestinal disorders. For screening, the Bowel Disease Questionnaire will be used to exclude subjects with irritable bowel syndrome.
• 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.
• Female subjects who are pregnant or breast feeding.
• Females must be either surgically sterilized, postmenopausal (\>12 months since last menses) or, if of childbearing potential, using reliable methods of contraception as determined by the physician (single-barrier methods alone and rhythm methods are not acceptable).
• Clinical evidence (including physical exam and ECG) of significant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological, psychiatric, or other disease that interfere with the objectives of the study. Any candidate participants with such disorder mentioned will be referred to their general physician.
• Symptoms of a significant clinical illness in the preceding two weeks.
• Participation in another clinical study within the past 30 days.
• Subjects who are considered by the investigator to be alcoholics not in remission or known substance abusers.

Sponsors & Collaborators

• Mayo Clinic: lead

Study Officials

• Michael L Camilleri, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: December 22, 2007
• First Posted: January 8, 2008
• Study Start: October 1, 2007
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: July 22, 2009

Record last verified: 2009-07