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Post-Market Evaluation of HEMOBLAST™ Bellows in Open Gynecological, Urological, ENT, Head, Neck, and Vascular Surgeries (NOBLE-Open)

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ClinicalTrials.gov Identifier: NCT03873168
Recruitment Status : Recruiting
First Posted : March 13, 2019
Last Update Posted : September 5, 2019
Sponsor:
Information provided by (Responsible Party):
Biom'Up SA

Brief Summary:
A prospective, multi-center, multi-national single arm study to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT and head and neck, and vascular surgery.

Condition or disease Intervention/treatment
Hemostasis Device: HEMOBLAST™ Bellows

Detailed Description:
A prospective, multi-center, multi-national single arm study conducted in Austria, France, and Germany to evaluate the performance and safety of HEMOBLAST™ Bellows in open gynecological, urological, ENT, head and neck, and vascular surgery. Up to 120 subjects will be enrolled at up to 10 sites, with a minimum of 8 subjects enrolled in each surgical specialty.

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Study Type : Observational
Estimated Enrollment : 120 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Market Evaluation of HEMOBLAST™ Bellows Performance and Safety in Open Gynecological, Urological, ENT, Head and Neck, and Vascular Surgeries
Actual Study Start Date : May 9, 2019
Estimated Primary Completion Date : April 2020
Estimated Study Completion Date : April 2020

Intervention Details:
  • Device: HEMOBLAST™ Bellows
    Surgeon has chosen to use HEMOBLAST™ Bellows as an adjunct to hemostasis when control of minimal, mild, or moderate bleeding by conventional procedures is ineffective or impractical in gynecological, urological, vascular, ENT and head and neck surgeries.


Primary Outcome Measures :
  1. Achievement of Hemostasis [ Time Frame: Intraoperatively, expected within 3-10 minutes of application ]
    The proportion of subjects for which hemostasis was achieved after application of HEMOBLAST™ Bellows.


Secondary Outcome Measures :
  1. Re-bleeding at Target Bleeding Site [ Time Frame: Intraoperative, prior to surgical closure of the subject ]
    The rate of target bleeding site re-bleeding after hemostasis has been achieved with HEMOBLAST™ Bellows

  2. Re-operation due to bleeding [ Time Frame: Post-operatively, expected within 1-30 days of the surgical procedure ]
    The rate of re-operation due to post-operative bleeding/hemorrhage after treatment with HEMOBLAST™ Bellows



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects undergoing open gynecological, urological, ENT and head and neck, and vascular procedures that meet all of the inclusion criteria and none of the exclusion criteria.
Criteria

Pre-operative Inclusion Criteria:

  • Patient is undergoing a non-emergent open gynecological, urological, ENT, head and neck, or vascular surgery
  • Patient is willing and able to give prior written informed consent for investigation participation;
  • Patient is 18 years of age or older.

Intra-operative Inclusion Criteria

  • Patient has one or more target bleeding sites (TBS) for which control of bleeding by conventional procedures is ineffective or impractical.
  • The TBS(s) has been treated with HEMOBLASTTM Bellows as per their instructions for use.

Exclusion Criteria:

  • Patient is pregnant, planning on becoming pregnant during the follow-up period, or actively breast-feeding;
  • Patient has a known sensitivity or allergy to bovine and/or porcine substance(s) or any other component(s) of the hemostatic agent;
  • Patient has religious or other objections to porcine, bovine, or human components;
  • Patient has any significant coagulation disorder;
  • Patient has any other contraindications, warnings, precautions of the Approved Instruction For Use of HEMOBLAST™ Bellows preventing his/ her inclusion
  • Patient is not appropriate for inclusion in the clinical trial, per the medical opinion of the Investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03873168


Contacts
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Contact: Dirk Pauwels +33 7 60 83 81 32 d.pauwels@biomup.com
Contact: Rachel Hoffman r.hoffman@biomup.com

Locations
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Austria
Uniklinikum Recruiting
Salzburg, Austria
Contact: Lukas Lususardi, MD         
France
Centre Hospitalier Universitaire d'Angers Recruiting
Angers, France
Contact: Laurent Catala, MD         
Germany
Universitatsklinikum Bonn Recruiting
Bonn, Germany, 53127
Contact: Tim Vilz, MD         
Agaplesion Markus krankenhaus Recruiting
Frankfurt, Germany, 60487
Contact: Mark Thill, MD         
Sponsors and Collaborators
Biom'Up SA
Investigators
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Principal Investigator: Tim Vilz, MD Unversity Hospital Bonn

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Responsible Party: Biom'Up SA
ClinicalTrials.gov Identifier: NCT03873168     History of Changes
Other Study ID Numbers: ETC 2018-001
First Posted: March 13, 2019    Key Record Dates
Last Update Posted: September 5, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No