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NCT00116233 Clinical Trial

Pediatric Multicenter Study of REPEL-CV

Adhesions Clinical Trial

Official title:
Peds. Multicenter Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT00116233
Other study ID # LMS0104RCV
Secondary ID
Status Recruiting
Phase Phase 2
First received June 27, 2005
Last updated June 27, 2005

Study information
Verified date June 2005
Source SyntheMed
Contact Eli Pines, Ph.D.
Phone 212-460-9488
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

This trial will study REPEL-CV for reducing post operative adhesions following cardiovascular (cv) surgery.

Description:

- Efficacy at second sternotomy

Recruitment information / eligibility
Status Recruiting
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 1 Year
Eligibility Inclusion Criteria:

- Stage sternotomies

Exclusion Criteria:

- Delayed closure beyond 5 days

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Device:
• REPEL-CV

Locations
Country Name City State
United States SyntheMed Little Silver New Jersey

Sponsors (1)
Lead Sponsor Collaborator
SyntheMed

Country where clinical trial is conducted

United States, 

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