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Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03772912
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : December 12, 2018
Last Update Posted : December 14, 2018
Sponsor:
Information provided by (Responsible Party):
Biom'Up France SAS

Brief Summary:
The purpose of this post-market observational registry is to collect additional data on the safety and effectiveness of the HEMOBLAST™ Bellows device in total knee arthroplasty procedures.

Condition or disease Intervention/treatment
Arthroplasty, Replacement, Knee Device: HEMOBLAST Bellows

Detailed Description:

A maximum of 100 subjects will be enrolled at up to 5 centers in the United States.

Enrollment occurs intraoperatively after confirmation of eligibility criteria. Data collection will occur during the surgical procedure as well as during patient follow up and will follow site standard of care. Subjects will be discontinued from the study after completion of the final follow up visit. The estimated duration of the study is approximately 10 months from the time of first subject enrollment to completion of the last subject follow up.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 1 Day
Official Title: Registry for the Use of HEMOBLAST Bellows in Total Knee Arthroplasty
Estimated Study Start Date : December 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Knee Replacement

Group/Cohort Intervention/treatment
Total Knee Arthroplasty Patients
Patients undergoing primary or revision total knee arthroplasty procedures in which the surgeon elects to use HEMOBLAST Bellows to control minimal, mild, or moderate bleeding for which conventional means of hemostasis are ineffective or impractical
Device: HEMOBLAST Bellows
The HEMOBLAST™ Bellows hemostatic agent consists of a bellows pre-loaded with 1.65g of powder composed of collagen, chondroitin sulfate, and thrombin (1500 IU). HEMOBLAST™ Bellows is indicated in surgical procedures as an adjunct to hemostasis when control of minimal, mild, and moderate bleeding by conventional procedures is ineffective or impractical, except in neurosurgical, ophthalmic, and urological procedures.




Primary Outcome Measures :
  1. Achievement of Hemostasis at the Target Bleeding Site [ Time Frame: Intraoperatively, expected within 3-10 minutes of application ]
    The ability of HEMOBLAST Bellows to achieve hemostasis (i.e. cessation of bleeding) at the target bleeding site will be assessed


Secondary Outcome Measures :
  1. Incidence of Serious Adverse Device Effects (SADEs) [ Time Frame: Through study completion, on average 1-2 days post-surgery ]
    The incidence of Serious Adverse Events deemed possibly, probably, or definitely related to the device will be quantified

  2. Incidence of Unanticipated Serious Adverse Device Effects (UADEs) [ Time Frame: Through study completion, on average 1-2 days post-surgery ]
    The incidence of Serious Adverse Events that are both unanticipated and deemed by the investigator to be possibly, probably, or definitely related to the device



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing elective, unilateral total knee arthroplasty procedures that meet all eligibility criteria.
Criteria

Preoperative Inclusion Criteria:

  • Patient is undergoing a unilateral total knee arthroplasty procedure; and
  • Patient is willing and able to give written informed consent for registry participation.

Preoperative Exclusion Criteria:

  • Patient has a known sensitivity or allergy to bovine and/or porcine substance(s); and
  • Patient has religious or other objections to porcine, bovine, or human components.

Intraoperative Inclusion Criteria

  • Patient has at least one Target Bleeding Site (TBS) with minimal, mild, or moderate bleeding for which conventional means for hemostasis are ineffective or impractical; and
  • The surgeon elects to utilize HEMOBLAST™ Bellows per its approved Indication for Use.
Additional Information:

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Responsible Party: Biom'Up France SAS
ClinicalTrials.gov Identifier: NCT03772912    
Other Study ID Numbers: ETC 2018-006
First Posted: December 12, 2018    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Biom'Up France SAS:
Hemostatics
Coagulants