Back to resultsPediatric Multicenter Study of REPEL-CV
Primary Purpose
Adhesions
Status
Unknown status
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
REPEL-CV
Sponsored by
About this trial
This is an interventional treatment trial for Adhesions focused on measuring post operative adhesions
Eligibility Criteria
Inclusion Criteria: Stage sternotomies Exclusion Criteria: Delayed closure beyond 5 days
Sites / Locations
- SyntheMedRecruiting
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00116233
Brief Title
Pediatric Multicenter Study of REPEL-CV
Official Title
Peds. Multicenter Study
Study Type
Interventional
2. Study Status
Record Verification Date
June 2005
Overall Recruitment Status
Unknown status
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
SyntheMed
4. Oversight
5. Study Description
Brief Summary
This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular (cv) surgery.
Detailed Description
- Efficacy at second sternotomy
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesions
Keywords
post operative adhesions
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Single
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
REPEL-CV
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Day
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Stage sternotomies
Exclusion Criteria:
Delayed closure beyond 5 days
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eli Pines, Ph.D.
Phone
212-460-9488
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eli Pines
Organizational Affiliation
SyntheMed
Official's Role
Study Director
Facility Information:
Facility Name
SyntheMed
City
Little Silver
State/Province
New Jersey
ZIP/Postal Code
07739
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eli Pines, Ph.D.
Phone
212-460-9488
12. IPD Sharing Statement
Learn more about this trial
Pediatric Multicenter Study of REPEL-CV
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