NCT00958672

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2009

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2009

Completed
15 days until next milestone

Study Start

First participant enrolled

August 1, 2009

Completed
12 days until next milestone

First Posted

Study publicly available on registry

August 13, 2009

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

June 19, 2014

Status Verified

June 1, 2014

Enrollment Period

2.1 years

First QC Date

July 17, 2009

Last Update Submit

June 18, 2014

Conditions

Systemic Sclerosis

Outcome Measures

Primary Outcomes (1)

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

    1 year

Secondary Outcomes (3)

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

    1 year

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

    1 year

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

    1 year

Interventions

Endoscopic capsuleOTHER

Endoscopic capsule

Eligibility Criteria

Age18 Years - 81 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU-Rouen

Rouen, Rouen, 76031, France

Location

MeSH Terms

Conditions

Scleroderma, Systemic

Interventions

Endoscopy

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques, SurgicalDiagnostic Techniques and ProceduresDiagnosisMinimally Invasive Surgical ProceduresSurgical Procedures, Operative

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2009

First Posted

August 13, 2009

Study Start

August 1, 2009

Primary Completion

September 1, 2011

Study Completion

September 1, 2011

Last Updated

June 19, 2014

Record last verified: 2014-06

Locations

FR(1)