Small Intestinal Mucosal Abnormalities in Systemic Sclero... | NCT00958672

Studies
Small Intestinal Mucosal Abnormalities in Systemic Sclerosis Using Capsule Endoscopy

NCT00958672

Sponsor

University Hospital, Rouen

Status

Completed

Last Update Posted

Jun 19, 2014Estimated

Enrollment

50Actual

Phase

Not provided

Conditions

Systemic Sclerosis

Interventions

Endoscopic capsule

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2009

Primary Completion Date

Sep 2011Actual

Completion Date

Sep 2011Actual

First Submitted Date

Jul 17, 2009

First Submission Date that Met QC Criteria

Aug 12, 2009

First Posted Date

Aug 13, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 18, 2014

Last Update Posted Date

Jun 19, 2014Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Name	Type	Description	Arm Group Labels	Other Names
Endoscopic capsule	Other	Endoscopic capsule

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Prevalence and characteristics of small intestinal mucosal involvement in 40 patients with systemic sclerosis		1 year

Secondary Outcomes

Measure	Description	Time Frame
- 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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
Systemic sclerosis based on the ACR diagnostic criteria

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

81 Years

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
CHU-Rouen		Rouen	Rouen	76031	France

Condition Browse Module

MeSH Terms

ID	Term
D012595	Scleroderma, Systemic

Ancestor Terms

ID	Term
D003240	Connective Tissue Diseases
D017437	Skin and Connective Tissue Diseases
D012871	Skin Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D004724	Endoscopy

Ancestor Terms

ID	Term
D003949	Diagnostic Techniques, Surgical
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis
D019060	Minimally Invasive Surgical Procedures

Browse Leaves

Not provided

Browse Branches

Not provided