Upper Gastrointestinal Motility DisordersNCT01026922
Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
An observational study of Upper Gastrointestinal Motility Disorders, run by Nationwide Children's Hospital at 1 site in United States.
Trial summary
This study will test a new medical device called the SmartPill GI Monitoring System, which is now used to diagnose gastric motility disorders in adults, in children. The study will compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard procedure currently used for the evaluation… Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Upper Gastrointestinal Motility Disorders
- Type of treatment
- Pill or oral medicine
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2009to Jun 2011
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients coming to clinic for concerns of gastric or small bowel dysmotility
Who may be able to join
- Children older than 10 years of age referred to our Motility Center to receive AD manometry studies will be offered participation to the study
- The patients will have to be able to swallow the SmartPill capsule
- The patients will need to have no evidence of strictures or narrowing
Who cannot join
- Inability to swallow the capsule
- Patients on TPN because of inability to tolerate enteral feedings (high likelihood of not emptying the capsule from the stomach)
- Children with evidence of strictures
- Children with history of esophageal or gastric surgeries, such as TE fistula, fundoplication, or gastrojejunostomy
- Children with a history of gastric bezoars
- Allergies to components of the test meal including eggs, bread, and jam
- Patients with history of inflammatory bowel disease
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Digestive Disorders at Nationwide Childrens Hospital
Columbus, Ohio, 43205
About this study
This study will test a new medical device called the SmartPill GI Monitoring System, which is now used to diagnose gastric motility disorders in adults, in children. The study will compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard procedure currently used for the evaluation of gastric and duodenal motility in children. The ADM studies will be done for clinical purposes and only if recommended by the patient's gastroenterologist. The research portion of the study is limited to the use of SmartPill.
Read the detailed description
ADM is a standard procedures used in children, but it has some limitations and disadvantages. Manometry studies involve placing catheters in the nose and are often poorly tolerated by children. Also, placement of the catheter requires sedation or anesthesia, the manometry test lasts several hours and involves ingestion of a meal which many children find difficult when having a catheter in their nose. The reason we are conducting this study is because we would like to find a new, less invasive, equally informative test for understanding gastrointestinal motility.
The SmartPill GI Monitoring System uses a capsule, about the size of a large vitamin or PillCam capsule, which is swallowed and passed through the stool. While in the GI tract, the capsule measures the acidity (pH) and pressures, and these measurements are used to determine how long it takes for food to leave the stomach. Pressure and pH information are sent by the capsule to a receiver that the patient will either wear on the belt or keep within 2 feet. The receiver stores data collected about the pH, temperature, and pressure inside the GI tract. The SmartPill GI Monitoring System has already been approved by the Food and Drug Administration (FDA) for use in adults but not in children.
- Keywords
- antroduodenal manometry, gastric dysmotility, intestinal dysmotility
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 |
|---|---|---|
| SmartPill Participants | It is a single-center study, children aged 8-17 years with severe upper GI symptoms (ie, nausea, vomiting, retching, abdominal pain) referred for antroduodenal manometry (ADM) studies underwent a wireless motility capsule (smartpill) test. The scintigraphic gastric emptying study was done when clinically indicated either at the time of the ADM or at a different time within 1 year of the wireless motility capsule test. In summary, we studied symptomatic adolescents using scintigraphic gastric emptying studies, ADM, and the wireless motility capsule test, with the goal of identifying the diagnostic yield of each test and exploring how they compare in detecting motor abnormalities in the GI tract. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determine if a patient's gastric and duodenal motility is considered normal or abnormal, if their motility disorder considered as neuropathic (normal amplitude of contractions) or myopathic (low amplitude or absent contractions) based on ADM vs SmartPill
Determine if a patient's gastric and duodenal motility is considered normal or abnormal, if their motility disorder considered as neuropathic (normal amplitude of contractions) or myopathic (low amplitude or absent contractions) based on ADM vs SmartPill. The goal is to identify the diagnostic yield of each test and exploring how they compare in detecting motor abnormalities in the GI tract.
Measured: SmartPill use will be within 180 days of ADM
Secondary outcomes (1)
The patient's tolerance using the Smartpill
Assess the tolerability and safety of the wireless motility capsule test.
Measured: The day the patient returns the SmartPill recording device
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Upper Gastrointestinal Motility DisordersStudies of the same condition, open and under way.
- More trials run by Nationwide Children's HospitalThe 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
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nationwide Children's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The SmartPill Corporation
- Responsible party
- Principal investigator, Carlo Di Lorenzo, Nationwide Children's Hospital
- Investigators
- Carlo Di Lorenzo, MD, Principal investigator, Nationwide Children's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01026922
- Sponsor's protocol ID
- NCHSmartPill-01
- Status last verified
- Jul 2018
- First submitted
- 4 Dec 2009
- Last updated
- 19 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kuo B, McCallum RW, Koch KL, Sitrin MD, Wo JM, Chey WD, Hasler WL, Lackner JM, Katz LA, Semler JR, Wilding GE, Parkman HP. Comparison of gastric emptying of a nondigestible capsule to a radio-labelled meal in healthy and gastroparetic subjects. Aliment Pharmacol Ther. 2008 Jan 15;27(2):186-96. doi: 10.1111/j.1365-2036.2007.03564.x. Epub 2007 Oct 28.
PubMed 17973643Cassilly D, Kantor S, Knight LC, Maurer AH, Fisher RS, Semler J, Parkman HP. Gastric emptying of a non-digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy. Neurogastroenterol Motil. 2008 Apr;20(4):311-9. doi: 10.1111/j.1365-2982.2007.01061.x. Epub 2008 Jan 13.
PubMed 18194154Rao SS, Kuo B, McCallum RW, Chey WD, DiBaise JK, Hasler WL, Koch KL, Lackner JM, Miller C, Saad R, Semler JR, Sitrin MD, Wilding GE, Parkman HP. Investigation of colonic and whole-gut transit with wireless motility capsule and radiopaque markers in constipation. Clin Gastroenterol Hepatol. 2009 May;7(5):537-44. doi: 10.1016/j.cgh.2009.01.017.
PubMed 19418602
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of an Ambulatory Capsule to Characterize Gastrointestinal Pressure Patterns in Children
- ClinicalTrials.gov ID
- NCT01026922
- Acronym / sponsor ID
- NCHSmartPill-01
- Keywords
- antroduodenal manometry, gastric dysmotility, intestinal dysmotility
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Nationwide Children's HospitalUniversity, hospital or other
- Collaborators
- The SmartPill Corporation
- Study start
- Dec 2009
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Dec 2009 (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.
This study will test a new medical device called the SmartPill GI Monitoring System, which is now used to diagnose gastric motility disorders in adults, in children. The study will compare the SmartPill capsule findings to antroduodenal manometry (ADM), which is a standard procedure currently used for the evaluation of gastric and duodenal motility in children. The ADM studies will be done for clinical purposes and only if recommended by the patient's gastroenterologist. The research portion of the study is limited to the use of SmartPill.
Detailed description
ADM is a standard procedures used in children, but it has some limitations and disadvantages. Manometry studies involve placing catheters in the nose and are often poorly tolerated by children. Also, placement of the catheter requires sedation or anesthesia, the manometry test lasts several hours and involves ingestion of a meal which many children find difficult when having a catheter in their nose. The reason we are conducting this study is because we would like to find a new, less invasive, equally informative test for understanding gastrointestinal motility.
The SmartPill GI Monitoring System uses a capsule, about the size of a large vitamin or PillCam capsule, which is swallowed and passed through the stool. While in the GI tract, the capsule measures the acidity (pH) and pressures, and these measurements are used to determine how long it takes for food to leave the stomach. Pressure and pH information are sent by the capsule to a receiver that the patient will either wear on the belt or keep within 2 feet. The receiver stores data collected about the pH, temperature, and pressure inside the GI tract. The SmartPill GI Monitoring System has already been approved by the Food and Drug Administration (FDA) for use in adults but not in children.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SmartPill Participants | – | –It is a single-center study, children aged 8-17 years with severe upper GI symptoms (ie, nausea, vomiting, retching, abdominal pain) referred for antroduodenal manometry (ADM) studies underwent a wireless motility capsule (smartpill) test. The scintigraphic gastric emptying study was done when clinically indicated either at the time of the ADM or at a different time within 1 year of the wireless motility capsule test. In summary, we studied symptomatic adolescents using scintigraphic gastric emptying studies, ADM, and the wireless motility capsule test, with the goal of identifying the diagnostic yield of each test and exploring how they compare in detecting motor abnormalities in the GI tract. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients coming to clinic for concerns of gastric or small bowel dysmotility
Key inclusion criteria (3 listed)
- Children older than 10 years of age referred to our Motility Center to receive AD manometry studies will be offered participation to the study
- The patients will have to be able to swallow the SmartPill capsule
- The patients will need to have no evidence of strictures or narrowing
Key exclusion criteria (7 listed)
- Inability to swallow the capsule
- Patients on TPN because of inability to tolerate enteral feedings (high likelihood of not emptying the capsule from the stomach)
- Children with evidence of strictures
- Children with history of esophageal or gastric surgeries, such as TE fistula, fundoplication, or gastrojejunostomy
- Children with a history of gastric bezoars
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
Determine if a patient's gastric and duodenal motility is considered normal or abnormal, if their motility disorder considered as neuropathic (normal amplitude of contractions) or myopathic (low amplitude or absent contractions) based on ADM vs SmartPill
Time frame: SmartPill use will be within 180 days of ADM
Determine if a patient's gastric and duodenal motility is considered normal or abnormal, if their motility disorder considered as neuropathic (normal amplitude of contractions) or myopathic (low amplitude or absent contractions) based on ADM vs SmartPill. The goal is to identify the diagnostic yield of each test and exploring how they compare in detecting motor abnormalities in the GI tract.
1 secondary outcome
The patient's tolerance using the Smartpill
Time frame: The day the patient returns the SmartPill recording device
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 19 Jul 2018.
- Background: PubMed 17973643Kuo B, McCallum RW, Koch KL, Sitrin MD, Wo JM, Chey WD, Hasler WL, Lackner JM, Katz LA, Semler JR, Wilding GE, Parkman HP. Comparison of gastric emptying of a nondigestible capsule to a radio-labelled meal in healthy and gastroparetic subjects. Aliment Pharmacol Ther. 2008 Jan 15;27(2):186-96. doi: 10.1111/j.1365-2036.2007.03564.x. Epub 2007 Oct 28.
- Background: PubMed 18194154Cassilly D, Kantor S, Knight LC, Maurer AH, Fisher RS, Semler J, Parkman HP. Gastric emptying of a non-digestible solid: assessment with simultaneous SmartPill pH and pressure capsule, antroduodenal manometry, gastric emptying scintigraphy. Neurogastroenterol Motil. 2008 Apr;20(4):311-9. doi: 10.1111/j.1365-2982.2007.01061.x. Epub 2008 Jan 13.
- Background: PubMed 19418602Rao SS, Kuo B, McCallum RW, Chey WD, DiBaise JK, Hasler WL, Koch KL, Lackner JM, Miller C, Saad R, Semler JR, Sitrin MD, Wilding GE, Parkman HP. Investigation of colonic and whole-gut transit with wireless motility capsule and radiopaque markers in constipation. Clin Gastroenterol Hepatol. 2009 May;7(5):537-44. doi: 10.1016/j.cgh.2009.01.017.
- Individual participant dataSharing planned: No
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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.
Carlo Di Lorenzo, MD principal investigator
Nationwide Children's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Upper Gastrointestinal Motility Disorders, run by Nationwide Children's Hospital at 1 site 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 3 inclusion and 7 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 19 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Determine if a patient's gastric and duodenal motility is considered normal or abnormal, if their motility disorder considered as neuropathic (normal amplitude of contractions) or myopathic (low amplitude or absent contractions) based on ADM vs SmartPill (time frame: SmartPill use will be within 180 days of ADM). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01026922, which also lists 3 linked publications.
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 19 Jul 2018.