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NCT02359994 · ClinicalTrials.gov registry record · NA
Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System
A NA study, sponsored by Artivion.
- Completed
- Registry status
- NA
- Development phase
- 324
- Enrollment target
NCT02359994 is a NA study that has completed, run by Artivion. The registered enrollment target is 324 participants.
The verdict
NCT02359994, a NA study, has completed, sponsored by Artivion.
- COMPLETED
- Registry status
- NA
- Development phase
- 324 participants
- Enrollment target
Study Summary
This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device. Three hundred and twenty four subjects across a maximum of 25 investigational sites undergoing open elective cardiac, general, or urological surgical procedures who meet the eligibility criteria will be intraoperatively randomized to receive no more than the entire contents of up to two 5 gram bellows of either the investigational device or a control hemostatic agent on a bleeding site, whose anatomic site is smaller than or equal to 25cm² and whose anatomic application site is smaller than or equal to 47cm², when bleeding is within the pre-defined bleeding severity range after any applicable conventional means for hemostasis are attempted as specified in the intraoperative procedures. Each investigational site is expected to enroll approximately 13-40 subjects. All investigational sites will be located in the U.S. Follow-up will occur at hospital discharge and 6 weeks post-device application. For oncologic subjects, an additional follow up will occur at 24 months post device application.
Interventions
- DEVICE PerClot Polysaccharide Hemostatic System
- DEVICE Arista AH
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 324 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-02-20 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02359994
The ClinicalTrials.gov registry entry for NCT02359994 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 324 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Artivion, which has 7 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which PerClot Polysaccharide Hemostatic System is the first listed.
NCT02359994 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02359994 about?
NCT02359994 is a clinical study titled "Prospective, Multicenter, Multidisciplinary, Controlled Clinical Investigation Evaluating the Safety and Efficacy of PerClot® Polysaccharide Hemostatic System". This is a prospective, multicenter, multidisciplinary, controlled clinical investigation evaluating the safety and efficacy of PerClot in achieving intraoperative hemostasis compared to a similar marketed hemostatic device. Three hundred and twenty four subjects across a maximum of 25 investigation...
What is the current status of trial NCT02359994?
This trial is currently completed. It is a NA study. The enrollment target is 324 participants. The study started on 2015-04. Estimated completion is 2019-02-20.
What interventions are being tested in trial NCT02359994?
The interventions under investigation include: PerClot Polysaccharide Hemostatic System (DEVICE), Arista AH (DEVICE).
Who is sponsoring clinical trial NCT02359994?
This trial is sponsored by Artivion, which has 7 total clinical trials registered on ClinicalTrials.gov.
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