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Pediatric Multicenter Study of REPEL-CV

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2005 by SyntheMed.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
SyntheMed
ClinicalTrials.gov Identifier:
NCT00116233
First received: June 27, 2005
Last updated: NA
Last verified: June 2005
History: No changes posted
  Purpose

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


Condition Intervention Phase
Adhesions
 Device: REPEL-CV
 Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Peds. Multicenter Study

Resource links provided by NLM:

MedlinePlus related topics: Adhesions
U.S. FDA Resources

Further study details as provided by SyntheMed:

Detailed Description:

- Efficacy at second sternotomy

  Eligibility

Ages Eligible for Study:   up to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Stage sternotomies

Exclusion Criteria:

  • Delayed closure beyond 5 days
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00116233

Contacts
Contact: Eli Pines, Ph.D. 212-460-9488

Locations
United States, New Jersey
SyntheMed Recruiting
Little Silver, New Jersey, United States, 07739
Contact: Eli Pines, Ph.D.     212-460-9488        
Sponsors and Collaborators
SyntheMed
Investigators
Study Director: Eli Pines SyntheMed
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00116233     History of Changes
Other Study ID Numbers: LMS0104RCV
Study First Received: June 27, 2005
Last Updated: June 27, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by SyntheMed:
post operative adhesions

Additional relevant MeSH terms:
Tissue Adhesions
Cicatrix
Fibrosis
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013