Healthy3DUSstomachNCT00588224
3D Ultrasound Validation for Measuring Stomach Volume
An observational study of Healthy, run by Mayo Clinic.
Trial 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. Read more about this study
- Who is it for?
- Ages 13 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 3D ultrasound
- How many people
- 36 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Jun 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 13 to 65 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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).
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- 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.
About this study
Official title: Validation and Application of 3-dimensional Ultrasound for Measurement of Gastric Volumes in Healthy Subjects
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.
Read the detailed description
Specific Aims
- To compare the fasting and postprandial volumes measured by 99mTc- SPECT (standard test) and 3-D ultrasound in 12 healthy adults in order to test latter's external validity
- To assess the performance characteristics of 3-D ultrasound for the measurement of gastric volumes during fasting and in response to a standard meal, specifically, the intra- and inter-individual coefficient of variation in 12 healthy adults who undergo two estimations of fasting and postprandial volumes
- To develop normative data for fasting and postprandial gastric volumes in 24 asymptomatic adolescents.
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
- Conditions
- Healthy
- Being tested
- 3D ultrasound
- Keywords
- stomach, accommodation, volume, SPECT, 3 dimensional ultrasonography, healthy volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D ultrasoundOther
measurement of stomach volume by 3D ultrasound
| Study group | Role | What they receive |
|---|---|---|
| 1 | adults Receives: Other: 3D ultrasound | |
| 2 | adolescents Receives: Other: 3D ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fasting and Postprandial gastric volumes measured by 3D ultrasonography in adults and adolescents
Measured: one month
Secondary outcomes (2)
Intra and inter-individual COV in adults for fasting and postprandial volumes
Measured: one month
Accuracy of 3D-ultrasonography in measurement of fasting and posprandial volume using Bland-Altman plot
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2008 (estimated)
- Study startOct 2007
- Primary completionJun 2008
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Investigators
- Michael L Camilleri, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00588224
- Sponsor's protocol ID
- 07-005231
- Acronym
- 3DUSstomach
- Status last verified
- Jul 2009
- First submitted
- 22 Dec 2007
- Last updated
- 22 Jul 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation and Application of 3-dimensional Ultrasound for Measurement of Gastric Volumes in Healthy Subjects
- ClinicalTrials.gov ID
- NCT00588224
- Acronym / sponsor ID
- 3DUSstomach / 07-005231
- Conditions
- Healthy
- Keywords
- stomach, accommodation, volume, SPECT, 3 dimensional ultrasonography, healthy volunteers
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2007
- Primary completion
- Jun 2008 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 8 Jan 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aims
- To compare the fasting and postprandial volumes measured by 99mTc- SPECT (standard test) and 3-D ultrasound in 12 healthy adults in order to test latter's external validity
- To assess the performance characteristics of 3-D ultrasound for the measurement of gastric volumes during fasting and in response to a standard meal, specifically, the intra- and inter-individual coefficient of variation in 12 healthy adults who undergo two estimations of fasting and postprandial volumes
- To develop normative data for fasting and postprandial gastric volumes in 24 asymptomatic adolescents.
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
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Other: 3D ultrasoundadults |
| 2 | – | Other: 3D ultrasoundadolescents |
Who may qualify
- Ages
- 13 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3D ultrasoundmeasurement of stomach volume by 3D ultrasound | Other | 1, 2 |
Primary outcome
Fasting and Postprandial gastric volumes measured by 3D ultrasonography in adults and adolescents
Time frame: one month
2 secondary outcomes
Intra and inter-individual COV in adults for fasting and postprandial volumes
Time frame: one month
Accuracy of 3D-ultrasonography in measurement of fasting and posprandial volume using Bland-Altman plot
Time frame: one month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael L Camilleri, MD principal investigator
Mayo Clinic
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy, run by Mayo Clinic.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 Jul 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fasting and Postprandial gastric volumes measured by 3D ultrasonography in adults and adolescents (time frame: one month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2009.