Pediatric Multicenter Study of REPEL-CV | NCT00116233

Studies
Pediatric Multicenter Study of REPEL-CV

NCT00116233

Sponsor

SyntheMed

Status

Unknown status

Last Update Posted

Jun 28, 2005Estimated

Enrollment

Not provided

Phase

Phase 2

Conditions

Adhesions

Interventions

REPEL-CV

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

Jun 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

Not provided

Start Date

Not provided

Primary Completion Date

Not provided

Completion Date

Not provided

First Submitted Date

Jun 27, 2005

First Submission Date that Met QC Criteria

Jun 27, 2005

First Posted Date

Jun 28, 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

Jun 27, 2005

Last Update Posted Date

Jun 28, 2005Estimated

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

Not provided

Name	Type	Description	Arm Group Labels	Other Names
REPEL-CV	Device

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Stage sternotomies

Exclusion Criteria:

Delayed closure beyond 5 days

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Day

Maximum Age

1 Year

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Eli Pines, Ph.D.	Contact	212-460-9488

Name	Affiliation	Role
Eli Pines	SyntheMed	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
SyntheMed	Recruiting	Little Silver	New Jersey	07739	United States

Condition Browse Module

MeSH Terms

ID	Term
D000267	Tissue Adhesions

Ancestor Terms

ID	Term
D002921	Cicatrix
D005355	Fibrosis
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided