CARTO 3 Human Patch Study | NCT00767390

Studies
CARTO 3 Human Patch Study

NCT00767390

Sponsor

Biosense Webster, Inc.

Status

Withdrawn

Last Update Posted

Oct 14, 2015Estimated

Enrollment

0Actual

Phase

Not provided

Conditions

Healthy

Interventions

ACL Patch

Countries

Not provided

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

Oct 2015

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

The required results were obtained through alternate methodology

Expanded Access Info

Start Date

Oct 2008

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Oct 3, 2008

First Submission Date that Met QC Criteria

Oct 3, 2008

First Posted Date

Oct 7, 2008Estimated

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

Oct 12, 2015

Last Update Posted Date

Oct 14, 2015Estimated

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 clinical investigation is to observe the changes in relative conductivity between the six ACL patches over time. In addition, the clinical investigation will evaluate the impact of prolonged placement of the ACL patches on subjects' skin on the chest and back. During the study the adhesiveness properties of the patches will be evaluated.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ACL Patch			Device: ACL Patch

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ACL Patch	Device	Observe and characterize the changes in relative conductivity between the six ACL patches over period of six hours. Investigation only involves passive data collection on pressure impact and adhesiveness properties of ACL patches.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absence of any clinically significant trauma to skin of the subjects at the ACL patches placement sites.		6 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Signed Subject Informed Consent Form
Healthy subject
Age Range: 20 - 50 years
BMI - half o the subjects 18-25 and half >25
Chest cage normal anatomy and dimensions
No history of skin contact patch allergy, of any kind

Exclusion Criteria:

Chest cage bony deformity
Known skin allergies to patches, or dermatological conditions requiring therapy
Presence of any active skin lesion on chest or back
Any condition that preclude subject from lying down for six hours with minimal movement
Pregnancy
Subjects with devices, such as pace makers, IC, loop recorder

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

Healthy Volunteers

Sampling Method

Non-Probability Sample