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CompletedNCT00958672sclero-videoUpdated Jun 19, 2014

Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy

An observational study in Systemic Sclerosis, sponsored by University Hospital, Rouen. Completed at 1 site in France. Open to participants aged 18 Years to 81 Years. Per ClinicalTrials.gov, last updated 2014-06-19.

Sponsored by University Hospital, Rouen · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years to 81 Years
Sex
All
01

Study 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.

02

Conditions studied

03

In context

Scleroderma, Systemic

688 studies on the registry are indexed under Scleroderma, Systemic; 223 are open to participants now.

This study's enrollment of 50 is below the median of 100 across 169 observational studies indexed under Scleroderma, Systemic.

Browse Scleroderma, Systemic studies →

Lead sponsor

University Hospital, Rouen is the lead sponsor of 410 studies on the registry; 104 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 81 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

40 consecutive patients with systemic sclerosis will be included in this prospective study, without prior selection on digestive clinical manifestations

Inclusion criteria

  • Written informed consent
  • Systemic sclerosis based on the ACR diagnostic criteria

Exclusion criteria

Exclusion Criteria:

  • Patients with other connective tissue diseases
  • Pregnancy
  • Absence of contraception in women
  • Patients with pace maker
  • Patients with intestinal pseudo-obstruction
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (actual)

Interventions

  • OtherEndoscopic capsule

    Endoscopic capsule

06

What researchers measure

Primary outcomes

  1. Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis

    Time frame: 1 year

Secondary outcomes

  1. - to assess a correlation between the presence of small intestinal mucosal abnormalities and digestive symptoms

    Time frame: 1 year

  2. to assess a correlation between small intestinal mucosal abnormalities and nutritional status

    Time frame: 1 year

  3. to assess a correlatio between small intestinal mucosal abnormalities and extra-intestinal manifestations of systemic sclerosis

    Time frame: 1 year

07

Study locations

1 site
  • CHU-Rouen
    Rouen, 76031, France
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 19, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00958672
Lead sponsor
University Hospital, Rouen
Responsible party
Sponsor
First posted
Aug 13, 2009
Start date
Aug 2009
Primary completion
Sep 2011
Completion
Sep 2011
Last update
Jun 19, 2014

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2014. You cannot join it, but the record below documents what was studied.

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