Gastrointestinal DiseasesGETOver65NCT00682877
A Comparison of SmartPill Capsule With Scintigraphy for Determining Gastric Residence Time - Over 65 Years Old
An observational study of Gastrointestinal Diseases and Stomach Diseases, run by The SmartPill Corporation at 2 sites in United States.
Trial summary
The purpose of this study is to determine the correlation between gastric residence time of the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled meal as measured by gastric emptying scintigraphy for subjects 65 years of age and older. Read more about this study
- Who is it for?
- Ages 65 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Gastrointestinal Diseases, Stomach Diseases, Gastroparesis
- How many people
- 23 participants
- Where
- 2 sitesUnited States
- Study dates
- Jul 2007to Nov 2007
- 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 65 to 80 years
- All sexes
- Healthy volunteers accepted
- Older adult
Study population: patients with gastroparesis referred to a tertiary motility center - 65 years of age and older.
Who may be able to join
- Healthy males and females between ages 65-80 years of age with no gastrointestinal disease as screened by the GI Disease Screening Questionnaire
- Average bowel movement frequency of at least one bowel movement within 48 hours
- Subjects with high probability for compliance and completion of the study
- Abnormal gastric emptying as defined by local standards and documented by nuclear medicine scintigraphy performed within the last two years.
- Males and females between ages 18-65 years of age.
- Average bowel movement frequency of at least one bowel movement within 72 hours
- Subjects with high probability for compliance and completion of the study
- Upper endoscopy or upper GI within last 3 years showing no evidence of gastric bezoar, stricture, or peptic ulcer.
Who cannot join
- Prior GI surgery
- Surgery within the past 3 months
- Diverticulitis
- Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
- Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
- Body mass index (BMI) > 35
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- Allergies to components of the test meal including eggs, bread, and jam.
- Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
- Cardiovascular, endocrine, renal, or other chronic disease likely to affect motility.
- History of gastric bezoar
- Severe dysphagia to solid food and pills
- Severe vomiting more than 1 time per day
- Diverticulitis
- Severe daily abdominal pain requiring medications for relief
- Severe weight loss, greater than 10 lbs over the preceding 2 months.
- Uncontrolled diabetes with a hemoglobin A1C greater than 10.
- Excessively delayed gastric emptying time: more than 90% of a standard egg meal retained after 2 hours.
- Previous gastro-esophageal surgery including vagotomy, fundoplication, gastric bypass, ulcer surgery.
- Prior GI surgery except for uncomplicated appendectomy and laparoscopic cholecystectomy
- Surgery within the past 3 months
- Tobacco use within eight hours prior to capsule ingestion and during the 8 hour monitoring time.
- Alcohol use within 24 hours prior to capsule ingestion and throughout the entire monitoring period (up to 72 hours).
- BMI > 35
- Allergies to components of the test meal including eggs, bread, and jam
- Female of childbearing age who is not practicing birth control and/or is pregnant or lactating. (Confirm with urine pregnancy test)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Division of Gastroenterology and Hepatology at KUMC
Kansas City, Kansas, 66160
About this study
Official title: A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time - In Subjects Over 65 Years of Age
The purpose of this study is to determine the correlation between gastric residence time of the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled meal as measured by gastric emptying scintigraphy for subjects 65 years of age and older.
Read the detailed description
Gastric emptying scintigraphy is considered the gold standard for evaluating gastric emptying and is widely available. Accurate characterization of gastric emptying may guide medical and surgical treatment choices. In addition, these techniques may allow for monitoring of therapeutic results for follow-up patient management.
The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 65 years of age and older.
- Conditions
- Gastrointestinal Diseases, Stomach Diseases, Gastroparesis
- Keywords
- gastroparesis, Digestive, Gastrointestinal, Stomach, Motility, Non-Invasive, Capsule, GI, Device, Digestive System Diseases
- Medical subject headings
- Gastrointestinal Diseases, Stomach Diseases, Gastroparesis, Digestive System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Normal | healthy adult subjects with no history or current gastrointestinal disorders or conditions | |
| Gastroparesis | Subjects with documented gastroparesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
To demonstrate the correlation between the gastric residence time as determined by SmartPill GI Monitoring System and the gastric emptying time of a radiolabeled meal in both healthy subjects and patients with documented gastroparesis.
Measured: 30 minute intervals up to 6 hours
Secondary outcomes (3)
To demonstrate that the gastric residence time as determined by SmartPill GI Monitoring System can discriminate between healthy human subjects and patients with gastroparesis
Measured: Continuous time measure until capsule elimination
To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis
Measured: Continuous time measure until capsule elimination
To characterize total GI transit time in healthy subjects
Measured: Continuous time measure until capsule elimination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2008 (estimated)
- Study startJul 2007
- Primary completionOct 2007
- Study completionNov 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gastrointestinal DiseasesStudies of the same condition, open and under way.
- 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
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- The SmartPill Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Braden Kuo, MD, Principal investigator, Massachusetts General HospitalJohn R Semler, PhD, Study director, SmartPill Corporation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00682877
- Sponsor's protocol ID
- 102204a
- Acronym
- GETOver65
- Status last verified
- May 2008
- First submitted
- 20 May 2008
- Last updated
- 23 May 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison Trial of SmartPill Corporation GI Monitoring System With Scintigraphic Gastric Emptying Procedure for Determining Gastric Residence Time - In Subjects Over 65 Years of Age
- ClinicalTrials.gov ID
- NCT00682877
- Acronym / sponsor ID
- GETOver65 / 102204a
- Conditions
- Gastrointestinal Diseases, Stomach Diseases, Gastroparesis
- Keywords
- gastroparesis, Digestive, Gastrointestinal, Stomach, Motility, Non-Invasive, Capsule, GI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- The SmartPill CorporationIndustry (pharma, biotech, devices)
- Study start
- Jul 2007
- Primary completion
- Oct 2007 (actual)
- Study completion
- Nov 2007 (actual)
- First posted
- 23 May 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 purpose of this study is to determine the correlation between gastric residence time of the SmartPill Capsule and the time required for partial emptying of a standard radiolabeled meal as measured by gastric emptying scintigraphy for subjects 65 years of age and older.
Detailed description
Gastric emptying scintigraphy is considered the gold standard for evaluating gastric emptying and is widely available. Accurate characterization of gastric emptying may guide medical and surgical treatment choices. In addition, these techniques may allow for monitoring of therapeutic results for follow-up patient management.
The SmartPill GI Monitoring System offers an alternative non-invasive method for characterizing disorders of the stomach. The system consists of an ingestible capsule that houses sensors for pH, temperature, and pressure, a receiver for receiving and storing signals from the capsule, and software for displaying data on a personal computer. The capsule samples at regular intervals and transmits the sensed pH, pressure, and temperature data to a portable receiver worn by the subject. After test completion, the recorded data is downloaded to a personal computer for subsequent evaluation. This trial is for subjects 65 years of age and older.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Normal | – | –healthy adult subjects with no history or current gastrointestinal disorders or conditions |
| Gastroparesis | – | –Subjects with documented gastroparesis |
Who may qualify
- Ages
- 65 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Older adult
- Study population
- patients with gastroparesis referred to a tertiary motility center - 65 years of age and older.
Key inclusion criteria (8 listed)
Key exclusion criteria (25 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To demonstrate the correlation between the gastric residence time as determined by SmartPill GI Monitoring System and the gastric emptying time of a radiolabeled meal in both healthy subjects and patients with documented gastroparesis.
Time frame: 30 minute intervals up to 6 hours
3 secondary outcomes
To demonstrate that the gastric residence time as determined by SmartPill GI Monitoring System can discriminate between healthy human subjects and patients with gastroparesis
Time frame: Continuous time measure until capsule elimination
To characterize pressure patterns within the antrum and duodenum in healthy subjects and patients with documented gastroparesis
Time frame: Continuous time measure until capsule elimination
To characterize total GI transit time in healthy subjects
Time frame: Continuous time measure until capsule elimination
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 23 May 2008.
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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.
Braden Kuo, MD principal investigator
Massachusetts General Hospital
John R Semler, PhD study director
SmartPill Corporation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastrointestinal Diseases and Stomach Diseases, run by The SmartPill Corporation at 2 sites in United States.
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 8 inclusion and 25 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 23 May 2008. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
To demonstrate the correlation between the gastric residence time as determined by SmartPill GI Monitoring System and the gastric emptying time of a radiolabeled meal in both healthy subjects and patients with documented gastroparesis. (time frame: 30 minute intervals up to 6 hours). 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 23 May 2008.