Performance of the Water-Enema Computed Tomography (WE-CT) | NCT00188110

Studies
Performance of the Water-Enema Computed Tomography (WE-CT)

NCT00188110

Sponsor

University Hospital, Angers

Status

Unknown status

Last Update Posted

Jan 9, 2007Estimated

Enrollment

200

Phase

Not Applicable

Conditions

Colon Cancer

Interventions

Water-Enema Computed Tomography

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

ID	Type	Description	Link
2002/23 (CCPPRB)

Status Module

Record Verification Date

Sep 2005

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2003

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Sep 12, 2005

First Submission Date that Met QC Criteria

Sep 12, 2005

First Posted Date

Sep 16, 2005Estimated

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

Jan 8, 2007

Last Update Posted Date

Jan 9, 2007Estimated

Name	Class
Ministry of Health, France	OTHER_GOV

Description Module

Brief Summary

The WE-CT is an innovative and easy practice imaging technique of colon tumors; it is based on the colon distension by a high volume of warm water and a multidetector CT acquisition after IV (intravenous) contrast, allowing image analysis including the wall thickness and enhancement, the pericolic adjacent spaces and the entire abdomen.

The goal of the study is the evaluation of its performances for the diagnosis of colon tumors.

Detailed Description

Not provided

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200

Name	Type	Description	Arm Group Labels	Other Names
Water-Enema Computed Tomography	Procedure

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To evaluate the performances of the WE-CT in patients suspected of having a colon tumor

Secondary Outcomes

Measure	Description	Time Frame
To show the CT findings in case of colon tumor and its pitfalls
To demonstrate the advantages of the WE-CT compared to the CT and magnetic resonance (MR) colonography for the diagnosis and local staging of colon tumors

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Written informed consent
WE-TC indication for colon tumor suspicion
Age > 18 years

Exclusion Criteria:

Pregnancy
Patients under 65 years old and for whom the only WE-TC indication is familial antecedents of colon tumor, without clinical or para-clinical personal signs for this pathology
Infected sigmoid diverticulosis
Occlusive syndrome
Anesthesia contraindications
Anal incontinence
Renal insufficiency (creatinine > 150 micromol/L)
Iode allergy
Visceralgine contraindications
Scania contraindications

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Christophe Aube, MD	Contact	00-2-41-35-42-76		chaube@chu-angers.fr

Overall Officials

Name	Affiliation	Role
Christophe Aube, MD	UH of Angers	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UH of Angers	Recruiting	Angers		49033	France

Condition Browse Module

MeSH Terms

ID	Term
D003110	Colonic Neoplasms

Ancestor Terms

ID	Term
D015179	Colorectal Neoplasms
D007414	Intestinal Neoplasms
D005770	Gastrointestinal Neoplasms
D004067	Digestive System Neoplasms

Browse Leaves

Not provided

Browse Branches

Not provided