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NCT01330433 · ClinicalTrials.gov registry record · Phase 2
Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery
A Phase 2 study, sponsored by Loma Linda University.
- Completed
- Registry status
- Phase 2
- Development phase
- 35
- Enrollment target
NCT01330433 is a Phase 2 study that has completed, run by Loma Linda University. The registered enrollment target is 35 participants.
The verdict
NCT01330433, a Phase 2 study, has completed, sponsored by Loma Linda University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 35 participants
- Enrollment target
Study Summary
This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (potential procedures include: Blalock-Taussig Type Operation, Classical Glenn Procedure, Bidirectional Glenn Procedure, Norwood). Additionally, bleeding will be evaluated by drainage post-operatively through surgical site drainage output.
Interventions
- DEVICE CoSeal Surgical Spray Group
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2011-08 |
| Est. Completion | 2015-08 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01330433
The ClinicalTrials.gov registry entry for NCT01330433 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Loma Linda University, which has 237 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which CoSeal Surgical Spray Group is the first listed.
NCT01330433 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01330433 about?
NCT01330433 is a clinical study titled "Effects of CoSeal on Bleeding & Adhesions in Pediatric Heart Surgery". This is a prospective, randomized, open-label, blinded-evaluator study that will evaluate the effectiveness of a surgical sealant (CoSeal) composed of biocompatible polyethylene glycol on the formation of mediastinal and pericardial adhesions in children undergoing staged surgical reconstruction (po...
What is the current status of trial NCT01330433?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 35 participants. The study started on 2011-08. Estimated completion is 2015-08.
What interventions are being tested in trial NCT01330433?
The interventions under investigation include: CoSeal Surgical Spray Group (DEVICE).
Who is sponsoring clinical trial NCT01330433?
This trial is sponsored by Loma Linda University, which has 237 total clinical trials registered on ClinicalTrials.gov.
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