Feasibility Study of a New Fistula Pouching System | NCT00294450

Studies
Feasibility Study of a New Fistula Pouching System

NCT00294450

Sponsor

Coloplast A/S

Status

Completed

Last Update Posted

Feb 1, 2012Estimated

Enrollment

22Actual

Phase

Phase 2Phase 3

Conditions

Cutaneous Fistula

Interventions

Fistula Pouching System

Countries

United States

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

Jan 2012

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

Feb 2006

Primary Completion Date

Mar 2007Actual

Completion Date

Mar 2007Actual

First Submitted Date

Feb 20, 2006

First Submission Date that Met QC Criteria

Feb 20, 2006

First Posted Date

Feb 22, 2006Estimated

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 31, 2012

Last Update Posted Date

Feb 1, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

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 purpose of this investigation is to carry out a clinical evaluation of a newly developed fistula pouching system's ability to function as a good pouch for fistulas, with the opening on the skin of the stomach or in a wound on the skin of the stomach.

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

Phase 2Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

22Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Fistula Pouching System	Device	3 different sizes of fistula pounching system		Fistula and Wound Management System

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Nurse's preference to use the test product in the future		Up to 18 days

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

18 years or older
Capable of giving informed consent
Have to be hospitalized
Have a fistula with the opening on the skin in the abdominal area

Exclusion Criteria:

Pregnant and/or breast-feeding
Receiving radiation- or chemotherapy during the investigation period

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

Not provided

Overall Officials

Name	Affiliation	Role
Thais Benjamin N. Christensen, M.Sc. (BME)	Coloplast A/S	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
St. Francis Hospital and Medical Center		Hartford	Connecticut	06105	United States
Morton Plant Hospital

Condition Browse Module

MeSH Terms

ID	Term
D017577	Cutaneous Fistula

Ancestor Terms

ID	Term
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D005402	Fistula
D020763	Pathological Conditions, Anatomical

Browse Leaves

Not provided

Browse Branches

Not provided