Systemic Sclerosissclero-videoNCT00958672
Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy
An observational study of Systemic Sclerosis, run by University Hospital, Rouen at 1 site in France.
Trial summary
The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis. Read more about this study
- Who is it for?
- Ages 18 to 81 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- Endoscopic capsule
- Type of treatment
- Pill or oral medicine
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Aug 2009to Sep 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 18 to 81 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 40 consecutive patients with systemic sclerosis will be included in this prospective study, without prior selection on digestive clinical manifestations
Who may be able to join
- Written informed consent
- Systemic sclerosis based on the ACR diagnostic criteria
Who cannot join
- Patients with other connective tissue diseases
- Pregnancy
- Absence of contraception in women
- Patients with pace maker
- Patients with intestinal pseudo-obstruction
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale
The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.
- Conditions
- Systemic Sclerosis
- Being tested
- Endoscopic capsule
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Endoscopic capsuleOther
Endoscopic capsule
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis
Measured: 1 year
Secondary outcomes (3)
- to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms
Measured: 1 year
to assess a correlation between small intestinal mucosal abnormalities and nutritional status
Measured: 1 year
to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2009 (estimated)
- Study startAug 2009
- Primary completionSep 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00958672
- Sponsor's protocol ID
- 2008/074/HP
- Acronym
- sclero-video
- Status last verified
- Jun 2014
- First submitted
- 17 Jul 2009
- Last updated
- 19 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation Des Anomalies Muqueuses Intestinales Par vidéocapsule Endoscopique au Cours de la sclérodermie systémique : Etude Prospective, Multicentrique et Inter-régionale
- ClinicalTrials.gov ID
- NCT00958672
- Acronym / sponsor ID
- sclero-video / 2008/074/HP
- Conditions
- Systemic Sclerosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- Aug 2009
- Primary completion
- Sep 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 13 Aug 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.
The aim of this prospective study is to determine prevalence and characteristics of small intestinal mucosal abnormalities in 40 patients with systemic sclerosis, using capsule endoscopy. The investigators' findings may improve management of small intestinal involvement in patients with systemic sclerosis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 81 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 40 consecutive patients with systemic sclerosis will be included in this prospective study, without prior selection on digestive clinical manifestations
Key inclusion criteria (2 listed)
- Written informed consent
- Systemic sclerosis based on the ACR diagnostic criteria
Key exclusion criteria (5 listed)
- Patients with other connective tissue diseases
- Pregnancy
- Absence of contraception in women
- Patients with pace maker
- Patients with intestinal pseudo-obstruction
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 |
|---|---|---|
| Endoscopic capsuleEndoscopic capsule | Other | – |
Primary outcome
Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis
Time frame: 1 year
3 secondary outcomes
- to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms
Time frame: 1 year
to assess a correlation between small intestinal mucosal abnormalities and nutritional status
Time frame: 1 year
to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis
Time frame: 1 year
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 Jun 2014.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Systemic Sclerosis, run by University Hospital, Rouen at 1 site in France.
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 2 inclusion and 5 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 Jun 2014. 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 France. 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?
Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis (time frame: 1 year). 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 19 Jun 2014; AzTrials last refreshed its copy on 30 Oct 2026.