Celiac DiseaseNCT00555737
Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy (MA-23)
An observational study of Celiac Disease, run by Medtronic - MITG at 5 sites in 3 countries.
Trial summary
The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Celiac Disease
- What is being tested?
- Capsule Endoscopy
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 102 participants
- Where
- 5 sitesin 3 countries
- Study dates
- Nov 2003to Jul 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: clinic paitnets with known Gluten sensitivity (Celaic).
Who may be able to join
- Patient age is 18 years or older
- Patient agrees to sign the Informed Consent Form
- Patient has positive celiac serology or negative celiac serology + IgA deficiency and suffers from one or more of the following symptoms and/or abdominal biochemical values:
- Chronic diarrhea
- Weight loss
- Abdominal cramps
Show all 13Show fewer
- History of spontaneous abortion
- Iron deficiency anemia
- Osteoporosis
- Infertility
- Hypoalbuminaemia
- Low cholesterol
- Low prothrombin activity
Who cannot join
- Patient is known or is suspected to suffer from intestinal obstruction.
- Patient has a cardiac pacemaker or other electro-medical device.
- Patient suffers from severe swallowing disorder or Zenker's diverticulum
- Patient has any condition, which precludes compliance with study and/or device instructions.
- Female patient is pregnant
- Patient suffers from life threatening conditions
- Patient is currently participating in another clinical study.
Trial locations and contacts
5 sites in 3 countries.
5 sites in 3 countries
Italy3 sites
Ospedale Maggiore - Policlinico
Milan, 20122
Universita Cattolica del Sacro Cuore
Rome
San Giovanni A.S. Hospital
Torino
United States1 site
University of Massachusetts Memorial Medical Center
Worcester, Massachusetts, 01655
About this study
Official title: Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy
The purpose of this study is to determine how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.
Read the detailed description
Gluten-sensitive enteropathy (GSE), also known as celiac disease, is characterized by abnormal small intestinal mucosa arising as a consequence of an inappropriate inflammatory response to ingested gluten in susceptible individuals.
These changes cause a loss of absorptive capacity which in turn leads to variable degrees of malabsorption. A person suffering from celiac may have symptoms ranging from mild iron deficiency anemia to severe diarrhea and weight loss. Characteristically, removal of gluten from the diet is followed by resolution of the mucosal changes and the symptoms.
Celiac disease is suspected on the basis of clinical signs and symptoms, and is generally confirmed by serological testing and small bowel biopsy. Patients with suspected celiac disease undergo upper GI endoscopy with mucosal biopsy of the duodenum, in order to detect the characteristic histological changes.
Although the main role for endoscopy in GSE is to obtain tissue for histological examination, a variety of endoscopic changes have been described in these patients,such as nodularity of the mucosa and 'scalloping' or loss of the duodenal mucosal folds.
The Given® Diagnostic System can visually investigate the small bowel, producing high-quality images of the mucosa, which might be able to detect villous atrophy and thus could be used in the assessment of patients with GSE. Whereas upper GI endoscopy is invasive, often requires sedation and may be uncomfortable, Capsule Endoscopy is less invasive, convenient to use and does not require sedation.
Capsule Endoscopy could become an important tool for the non-invasive assessment of small bowel mucosa in GSE.
- Conditions
- Celiac Disease
- Being tested
- Capsule Endoscopy
- Keywords
- Celiac Disease, Capsule Endoscopy, small Bowel Disease
- Medical subject headings
- Celiac Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Capsule EndoscopyDevice
Given® Diagnostic system with Pillcam SB
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin
Measured: within 14 days of enrollment
Secondary outcomes (1)
Longitudinal extent of villous changes in the small bowel will be evaluated.
Measured: within 14 days of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2007 (estimated)
- Study startNov 2003
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Celiac DiseaseStudies of the same condition, open and under way.
- More trials run by Medtronic - MITGThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medtronic - MITG
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Roberto de Franchis, MD, Prof., Principal investigator, Ospedale Maggiore - Policlinico, Milano, Italy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00555737
- Sponsor's protocol ID
- MA-23
- Status last verified
- Nov 2007
- First submitted
- 8 Nov 2007
- Last updated
- 31 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Performance Evaluation of Capsule Endoscopy in the Diagnosis of Gluten Sensitive Enteropathy
- ClinicalTrials.gov ID
- NCT00555737
- Acronym / sponsor ID
- MA-23
- Conditions
- Celiac Disease
- Keywords
- Celiac Disease, Capsule Endoscopy, small Bowel Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Medtronic - MITGIndustry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Jul 2007 (actual)
- First posted
- 9 Nov 2007 (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 how well capsule endoscopy identifies changes in the small bowel mucosa of celiac disease patients.
Detailed description
Gluten-sensitive enteropathy (GSE), also known as celiac disease, is characterized by abnormal small intestinal mucosa arising as a consequence of an inappropriate inflammatory response to ingested gluten in susceptible individuals.
These changes cause a loss of absorptive capacity which in turn leads to variable degrees of malabsorption. A person suffering from celiac may have symptoms ranging from mild iron deficiency anemia to severe diarrhea and weight loss. Characteristically, removal of gluten from the diet is followed by resolution of the mucosal changes and the symptoms.
Celiac disease is suspected on the basis of clinical signs and symptoms, and is generally confirmed by serological testing and small bowel biopsy. Patients with suspected celiac disease undergo upper GI endoscopy with mucosal biopsy of the duodenum, in order to detect the characteristic histological changes.
Although the main role for endoscopy in GSE is to obtain tissue for histological examination, a variety of endoscopic changes have been described in these patients,such as nodularity of the mucosa and 'scalloping' or loss of the duodenal mucosal folds.
The Given® Diagnostic System can visually investigate the small bowel, producing high-quality images of the mucosa, which might be able to detect villous atrophy and thus could be used in the assessment of patients with GSE. Whereas upper GI endoscopy is invasive, often requires sedation and may be uncomfortable, Capsule Endoscopy is less invasive, convenient to use and does not require sedation.
Capsule Endoscopy could become an important tool for the non-invasive assessment of small bowel mucosa in GSE.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- clinic paitnets with known Gluten sensitivity (Celaic).
Key inclusion criteria (13 listed)
- Patient age is 18 years or older
- Patient agrees to sign the Informed Consent Form
- Patient has positive celiac serology or negative celiac serology + IgA deficiency and suffers from one or more of the following symptoms and/or abdominal biochemical values:
Key exclusion criteria (7 listed)
- Patient is known or is suspected to suffer from intestinal obstruction.
- Patient has a cardiac pacemaker or other electro-medical device.
- Patient suffers from severe swallowing disorder or Zenker's diverticulum
- Patient has any condition, which precludes compliance with study and/or device instructions.
- Female patient is pregnant
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 |
|---|---|---|
| Capsule EndoscopyGiven® Diagnostic system with Pillcam SB | Device | – |
Primary outcome
The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin
Time frame: within 14 days of enrollment
1 secondary outcome
Longitudinal extent of villous changes in the small bowel will be evaluated.
Time frame: within 14 days of enrollment
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 31 Jul 2019.
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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.
Roberto de Franchis, MD, Prof. principal investigator
Ospedale Maggiore - Policlinico, Milano, Italy
5 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Celiac Disease, run by Medtronic - MITG at 5 sites in 3 countries.
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 13 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 31 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Italy, United States, Finland. 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?
The number of findings identified during the capsule endoscopy or upper GI endoscopy procedure, and which were considered by the investigator as related to the gluten sensitive enteropathy origin (time frame: within 14 days of enrollment). 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 31 Jul 2019.